BLUE GUIDE

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
European Commission
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http://europa.eu.int/comm/enterprise/newapproach/newapproach.htm
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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
3
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.
4
1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
1.1. Concept of the New Approach and the Global Approach . .7
1.2. Standard elements of New Approach directives . . . . . . . .8
1.3. Adoption of New Approach directives . . . . . . . . . . . . . .10
1.4. Transposition of New Approach directives . . . . . . . . . . .11
1.5. New Approach directives . . . . . . . . . . . . . . . . . . . . . .12
2. Scope of New Approach directives . . . . . . . . .15
2.1.Products submitted to directives . . . . . . . . . . . . . . . . . .15
2.2. Simultaneous application of directives . . . . . . . . . . . . . .16
2.2.1. New Approach directives . . . . . . . . . . . . . . . . . . . . .16
2.2.2. New Approach directives and the Directive on general
product safety . . . . . . . . . . . . . . . . . . . . . . . . . . .17
2.2.3. New Approach directives and the Directive on product
liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
2.3. Placing on the market and putting into service . . . . . . . .18
2.3.1. Placing on the market . . . . . . . . . . . . . . . . . . . . . .18
2.3.2. Putting into service . . . . . . . . . . . . . . . . . . . . . . . .19
2.4. Transitional period . . . . . . . . . . . . . . . . . . . . . . . . . . .19
3. Responsibilities . . . . . . . . . . . . . . . . . . . . . . . .21
3.1. Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
3.1.1. New Approach directives . . . . . . . . . . . . . . . . . . . . .21
3.1.2. The Directives on product liability and general product
safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
3.2. Authorised representative . . . . . . . . . . . . . . . . . . . . . .22
3.3. Importer/person responsible for placing on the market . .23
3.4. Distributor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
3.5. Assembler and installer . . . . . . . . . . . . . . . . . . . . . . .24
3.6. User (employer) . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
3.7. Product liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
4. Compliance with directives . . . . . . . . . . . . . . .27
4.1. Essential requirements . . . . . . . . . . . . . . . . . . . . . . . .27
4.2. Harmonised standards . . . . . . . . . . . . . . . . . . . . . . . .27
4.3. Presumption of conformity . . . . . . . . . . . . . . . . . . . . .29
4.4. Withdrawal of the presumption of conformity . . . . . . . . .29
4.5. Revision of harmonised standards . . . . . . . . . . . . . . . .30
5. Conformity assessment procedure . . . . . . . . .31
5.1. The modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
5.2. Application of quality system standards . . . . . . . . . . . . .33
5.3. Technical documentation . . . . . . . . . . . . . . . . . . . . . .34
5.4. EC declaration of conformity . . . . . . . . . . . . . . . . . . . .34
6. Notified bodies . . . . . . . . . . . . . . . . . . . . . . . .36
6.1. Principles of notification . . . . . . . . . . . . . . . . . . . . . . .36
6.2. Notification procedure and withdrawal of notification . . . .38
6.2.1. Notification procedure . . . . . . . . . . . . . . . . . . . . . .38
6.2.2. Withdrawal of notification . . . . . . . . . . . . . . . . . . . .39
6.3. General responsibilities of notified bodies . . . . . . . . . . .39
6.4. Notified bodies and conformity assessment . . . . . . . . . .41
6.5. Notified bodies and subcontracting . . . . . . . . . . . . . . .42
6.6. Coordination and cooperation . . . . . . . . . . . . . . . . . . .43
7. CE marking . . . . . . . . . . . . . . . . . . . . . . . . . . .44
7.1. Principles of CE marking . . . . . . . . . . . . . . . . . . . . . .44
7.2. Products to be CE marked . . . . . . . . . . . . . . . . . . . . .44
7.3. Affixing of the CE marking . . . . . . . . . . . . . . . . . . . . .45
7.4. CE marking and other marks . . . . . . . . . . . . . . . . . . .46
8. Market surveillance . . . . . . . . . . . . . . . . . . . . .47
8.1. Principles of market surveillance . . . . . . . . . . . . . . . . .47
8.2. Market surveillance activities . . . . . . . . . . . . . . . . . . . .48
8.2.1. Monitoring of products placed on the market . . . . . . .48
8.2.2. Corrective actions . . . . . . . . . . . . . . . . . . . . . . . . .50
8.2.3. Complementary activities . . . . . . . . . . . . . . . . . . . .51
8.3. Safeguard clause procedure . . . . . . . . . . . . . . . . . . . .52
8.3.1. Conditions for invoking the safeguard clause . . . . . . .52
8.3.2. Notification to the Commission . . . . . . . . . . . . . . . . .53
8.3.3. Administering the safeguard clause . . . . . . . . . . . . . .54
8.4. Protection of CE marking . . . . . . . . . . . . . . . . . . . . . .54
8.5. Information exchange systems . . . . . . . . . . . . . . . . . .55
8.5.1. Consumer products: rapid exchange of information . . .55
8.5.2. Medical devices: vigilance system . . . . . . . . . . . . . .56
8.5.3. Community injury data-collection and information
exchange system . . . . . . . . . . . . . . . . . . . . . . . . .56
8.5.4. Other information exchange systems
at Community level . . . . . . . . . . . . . . . . . . . . . . . .56
8.6. Administrative cooperation . . . . . . . . . . . . . . . . . . . . .57
8.6.1. Outline for administrative cooperation . . . . . . . . . . . .57
8.6.2. Infrastructures for administrative cooperation . . . . . . .58
8.7. Products imported from third countries . . . . . . . . . . . . .59
9. External aspects . . . . . . . . . . . . . . . . . . . . . . .62
9.1. Agreement on the European Economic Area . . . . . . . . .62
9.1.1. Basic elements of the Agreement . . . . . . . . . . . . . . .62
9.1.2. Notification of bodies . . . . . . . . . . . . . . . . . . . . . . .62
5
Contents
9.1.3. Safeguard clause procedure . . . . . . . . . . . . . . . . . .62
9.1.4. Mutual recognition agreements and European
conformity assessment protocols . . . . . . . . . . . . . . .63
9.2. Mutual recognition agreements . . . . . . . . . . . . . . . . . .63
9.3. European conformity assessment protocols . . . . . . . . . .64
9.4. Technical assistance . . . . . . . . . . . . . . . . . . . . . . . . .64
9.5. WTO Agreement on Technical Barriers to Trade . . . . . . .65
Annexes
Annex 1: Community legislation referred to in the Guide . . . . .67
Annex 2: Additional information concerning certain Articles
of the Treaty establishing the European Community
(the EC Treaty) . . . . . . . . . . . . . . . . . . . . . . . . . .71
Annex 3: Additional guidance documents . . . . . . . . . . . . . . .74
Annex 4: Commission contact points . . . . . . . . . . . . . . . . .77
Annex 5: Useful web addresses . . . . . . . . . . . . . . . . . . . . .79
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
procedures as provided for by the directives . . . . . .89
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
6
New barriers to trade, which result from the
adoption of diverging national technical
standards and regulations, can be prevented
through a procedure laid down by Directive
98/34/EC (1). Member States are
obliged to notify draft technical regulations
and standards to the Commission and to the other Member
States (2). During a standstill period these may not be
adopted, which leaves the Commission and the other Member
States the possibility to react. In the absence of reactions
within the initial standstill period of three months, the
draft technical regulations may then be adopted. Otherwise,
where objections are raised, a further three months standstill
is imposed. The standstill period is 12 months where
there is a proposal for a directive. However, the standstill
period does not apply where, for urgent reasons, a Member
State is obliged to introduce technical regulations in a very
short space of time in order to protect public health or safety,
animals or plants. Directive 98/34/EC also gives the
Commission the possibility of inviting, after consultation
with the Member States, the European standards organisations
to elaborate European standards.
National technical regulations are subject to the provisions
of Articles 28 and 30 of the Treaty establishing the
European Community (the EC Treaty), which prohibit quantitative
restrictions or measures having equivalent effect. Case
law of the European Court of Justice, especially case 120/78
(the ‘Cassis de Dijon’ case), provides the key elements for
mutual recognition. The effect of this case law is as follows.
* Products legally manufactured or marketed in one country
should in principle move freely throughout the Community,
where such products meet equivalent levels of protection to
those imposed by the Member State of exportation and where
they are marketed in the territory of the exporting country.
* In the absence of Community measures, Member States
are free to legislate on their territory.
* Barriers to trade, which result from differences between
national legislations, may only be accepted, if national
measures:
 are necessary to satisfy mandatory requirements (such
as health, safety, 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,
can only be avoided or eliminated through technical harmonisation
on Community level. This harmonisation was, at
first, rather slow for two reasons. First, the legislation
became highly technical, as it had the objective of meeting
the individual requirements of each product category. Second,
the adoption of technical harmonisation directives was
based on unanimity in the Council.
The creation of a single market by 31 December 1992
could not have been achieved without a new regulatory technique
that set down only the general essential requirements,
reduced the control of public authorities prior to a product
being placed on the market, and integrated quality assurance
and other modern conformity assessment techniques.
Moreover, the decision-making procedure needed to be
adapted in order to facilitate the adoption of technical harmonisation
directives by a qualified majority in the Council.
A new regulatory technique and strategy was laid down
by the Council Resolution of 1985 on the New Approach to
technical harmonisation and standardisation, which established
the following principles.
* Legislative harmonisation is limited to essential requirements
that products placed on the Community market must
meet, if they are to benefit from free movement within the
Community.
* The technical specifications of products meeting the
essential requirements set out in the directives are laid
down in harmonised standards.
* Application of harmonised or other standards remains
voluntary, and the manufacturer may always apply other
technical specifications to meet the requirements.
* Products manufactured in compliance with harmonised
standards benefit from a presumption of conformity with the
corresponding essential requirements (3).
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.
7
(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 C-
194/94).
(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.
Introduction
1.1. Concept of the New Approach and the Global Approach
Free movement of goods is a cornerstone of the single market.
The mechanisms in place to achieve this aim are based on
prevention of new barriers to trade, mutual recognition and
technical harmonisation.
Since the New Approach calls for essential requirements
to be harmonised and made mandatory by directives,
this approach is appropriate only where it is genuinely
possible to distinguish between essential requirements
and technical specifications. Further, a wide range of products
has to be sufficiently homogenous, or a horizontal
hazard identifiable, to allow common essential requirements.
The product area or hazard concerned must also be
suitable for standardisation (4).
In addition to the principles of the New Approach, conditions
for reliable conformity assessment are necessary.
The key elements in this respect are the building of confidence
through competence and transparency, and the
setting up of a comprehensive policy and framework for
conformity assessment. The Council Resolution of 1989
on the Global Approach to certification and testing states
the following guiding principles for Community policy on
conformity assessment.
* A consistent approach is developed in Community legislation
by devising modules for the various phases of conformity
assessment procedures, and by laying down criteria
for the use of these procedures, for the designation of bodies
operating these procedures, and for the use of the CE
marking.
* The use of European standards relating to quality assurance
(EN ISO 9000 series), and to the requirements to be
fulfilled by conformity assessment bodies operating quality
assurance (EN 45000 series) is generalised.
* Setting up of accreditation systems and
the use of inter-comparison techniques
are promoted in Member States and at
Community level.
* Mutual recognition agreements concerning
testing and certification in the nonregulatory
sphere are promoted.
* The differences of existing quality infrastructures
(such as calibration and metrology
systems, testing laboratories, certification
and inspection bodies, and accreditation
bodies) between Member States and
between industrial sectors are minimised by
programmes.
* International trade between the Community
and third countries is promoted by
means of mutual recognition agreements,
cooperation and technical assistance programmes.
The New Approach entailed refining conformity
assessment in such a way as to
allow the Community legislator to evaluate
the consequences of the utilisation of different
conformity assessment mechanisms.
The objective was to provide flexibility of conformity
assessment over the entire manufacturing process in order
for it to be adapted to the needs of each individual operation.
The Global Approach introduced a modular approach,
which subdivided conformity assessment into a number of
operations (modules). These modules differ according to
the stage of development of the product (for example
design, prototype, full production), the type of assessment
involved (for example documentary checks, type approval,
quality assurance), and the person carrying out the assessment
(the manufacturer or a third party).
The Global Approach was completed by Council Decision
90/683/EEC, which was replaced and brought up to
date by Decision 93/465/EEC. These decisions lay down
general guidelines and detailed procedures for conformity
assessment that are to be used in New Approach directives.
Thus, conformity assessment is based on:
 manufacturers’ internal design and production control
activities;
 third party type examination combined with manufacturers’
internal production control activities;
 third party type or design examination combined with
third party approval of product or production quality assurance
systems, or third party product verification (5);
 third party unit verification of design and production; or
 third party approval of full quality assurance systems.
In addition to laying down guidelines for the use of conformity
assessment procedures in technical harmonisation
directives, Decision 93/465/EEC harmonises the rules for
the affixing and use of the CE marking.
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
8
(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.
1.2. Standard elements of New Approach
directives (6)
 New Approach directives are based on the following
principles.
* Harmonisation is limited to essential requirements.
* Only products fulfilling the essential requirements may be
placed on the market and put into service.
* Harmonised standards, the reference numbers of which
have been published in the Official Journal and which have
been transposed into national standards, are presumed to conform
to the corresponding essential requirements.
* Application of harmonised standards or other technical
specifications remains voluntary, and manufacturers are free
to choose any technical solution that provides compliance
with the essential requirements.
* Manufacturers may choose between different conformity
assessment procedures provided for in the applicable directive.
Scope
The scope defines the range of products covered by the
directive, or the nature of hazards the directive is intended
to avert. It usually covers hazards related to a product or to
a phenomenon. Accordingly, several directives may apply to
the same product.
Scope of New Approach directives: Chapter 2.
Placing on the market and putting into service
Member States are obliged to take the necessary measures
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 public interests covered by the
directive, when properly installed, maintained and used for
the intended purposes. This entails an obligation for market
surveillance on the part of the Member States.
Member States are allowed to adopt, in compliance with
the Treaty (in particular Articles 28 and 30 of the EC Treaty),
additional national provisions to protect, in particular, workers,
consumers or the environment. However, these provisions
may neither require modifications of the product nor
influence the conditions for its placing on the market.
Placing on the market and putting into service: Section 2.3.
Market surveillance: Chapter 8
Essential requirements
Essential requirements are set out in the annexes to the
directives, and include all that is necessary to achieve the
objective of the directive. Products may be placed on the
market and put into service only if they are in compliance
with the essential requirements.
New Approach directives are generally designed to
cover all hazards related to the public interest that the directive
intends to protect. Thus, compliance with Community
legislation often requires simultaneous application of several
New Approach directives and, possibly, other Community
legislation. Further, some elements may have been left outside
the scope of applicable Community legislation. This
allows Member States to draw up national legislation in
accordance with Articles 28 and 30 of the EC Treaty.
Compliance with directives: Chapter 4.
Free movement
Member States must presume that products bearing the CE
marking comply with all the provisions of the applicable
directives providing for its affixing. Accordingly, Member
States may not prohibit, restrict or impede the placing on
the market and putting into service in their territory of products
bearing the CE marking, unless the provisions relating
to CE marking are incorrectly applied.
As an exception, Member States may prohibit, restrict
or impede the free movement of products bearing CE marking
– in accordance with Articles 28 and 30 of the EC Treaty
– because of a hazard that is not covered by the applicable
directives.
Placing on the market and putting into service: Section 2.3.
CE marking: Chapter 7.
Presumption of conformity
Products that comply with national standards transposing
harmonised standards, the reference numbers of which
have been published in the Official Journal of the European
Communities, are presumed to comply with the corresponding
essential requirements. Where the manufacturer
has not applied, or has only partially applied, such a standard,
the measures taken and their adequacy must be
documented in order to comply with the essential requirements.
Compliance with directives: Chapter 4.
Safeguard clause
Member States are obliged to take all appropriate measures
to prohibit or restrict the placing on the market of products
bearing the CE marking or to withdraw them from the
market, if these products might compromise the safety and
health of individuals or other public interests covered by the
applicable directives, when the products are used for their
intended purpose. Further, Member States must inform the
Commission when they take such a measure. Where the
Commission considers the national measure justified, it
informs all Member States who must take appropriate
action in view of their general obligation to enforce Community
legislation.
Market surveillance: Chapter 8.
Safeguard clause procedure: Section 8.3.
Conformity assessment
Before placing a product on the Community market, the
manufacturer must subject the product to a conformity
assessment procedure provided for in the applicable directive,
with the view to affixing the CE marking.
Conformity assessment procedure: Chapter 5.
Notified bodies
Third party conformity assessment is carried out by notified
bodies, which have been designated by the Member States
among bodies that fulfil the requirements laid down in the
directive and that are established on their territory.
Notified bodies: Chapter 6.
CE marking
Products in compliance with all provisions of the applicable
directives providing for the CE marking must bear this
marking. Thus, the CE marking is, in particular, an indication
that the products comply with the essential requirements
of applicable directives and that the products have
been subject to a conformity assessment procedure provided
for in the directives. Further, Member States are
obliged to take appropriate measures to protect the CE
marking.
CE marking: Chapter 7.
Protection of CE marking: Section 8.4.
❝ Introduction ❞
9
After receiving a Commission proposal,
the Council requests an opinion from the Parliament
and the Economic and Social Committee
before reaching its common position
on the proposal. Once the common position
has been reached, it is transmitted to the Parliament,
which may accept, reject or propose
amendments during this second reading. The
Commission re-examines its proposal in the
light of Parliament’s amendments, and returns
the proposal to the Council, which takes
a final decision within three months. If necessary,
problems are referred to a conciliation committee of
Council and Parliament, in which the Commission participates
as a moderator. The flow chart in Table 1.1 shows the adoption
procedure according to Article 251 of the EC Treaty, and
the alternatives at the different phases.
Up to the adoption of the common position, discussion
is based on the Commission’s proposal. While the Commission
can modify its proposal at any time, for example in the
light of the opinion of the Parliament, the Council can only
diverge from the Commission’s proposal by unanimity.
Coordination of implementation
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 Committee’s
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 interest
groups (for example notified bodies, standards organisations,
manufacturers, distributors, consumer organisations
and trade unions), and chaired by the Commission (7).
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.
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
10
(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.
1.3. Adoption of New Approach directives
 New Approach directives are based on Article 95 of the EC
Treaty, and adopted according to the co-decision procedure
provided for in Article 251 of the EC Treaty.
 Adopted New Approach directives are published in the L
series of the Official Journal of the European Communities.
Commission proposals for New Approach directives are published
in the C series of the Official Journal.
The legal basis for adopting or modifying New Approach
directives is Article 95 of the EC Treaty. According to Article
251 of the EC Treaty, the Commission initiates the legislative
procedure by making a proposal to the Council and
to the European Parliament. Such Commission proposals
concerning health, safety, environmental protection and
consumer protection should, according to Article 95 take
as a basis a high level of protection. Further, Article 95
requires that a safeguard clause is provided for in appropriate
cases.
❝ Introduction ❞
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.
The act is
adopted by
the Council.
The Council adopts
all the amendments
and the act.
The Council convenes
a meeting of the
conciliation committee.
The Council can convene
the conciliation committee
to explain its position.
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)
the act is adopted. The act is adopted, unless
the European Parliament
by an absolute majority
rejects the common
position in the last resort.
If the joint text is adopted
by the European Parliament
and the Council
The act is
not adopted.
The Council can confirm
the common position
by an absolute majority.
The act is
not adopted.
The conciliation committee
approves a joint text.
The conciliation committee
does not approve
a joint text.
The European Parliament
confirms its rejection of the
common position
by an absolute majority.
approves or does
not take a decision. proposes amendments. rejects.
Table 1/1 • Adoption of directives according to Article 251 of the EC Treaty •
lation. Further, Member States are, as a
general rule, not allowed to maintain or
introduce more stringent measures than
foreseen in the directive, as is the case for
directives adopted according to Article 138
of the EC Treaty (directives aiming to
improve the health and safety of workers,
especially, in the working environment) (8).
Directives are, according to Article 249
of the EC Treaty, binding on the Member
States as to the result to be achieved, but
the choice of form and method is their own.
Case law of the European Court of Justice
has clarified the contents of this obligation
and the possible measures to be taken
where a non-compliance can be established
(9).
It is up to the Member States to decide
which measures should be adopted and
published in order to comply with a directive. However,
Member States must take appropriate implementing measures
to transpose the directive in a way that fully meets the
1.4. Transposition of New Approach directives
 New Approach directives are total harmonisation directives:
the provisions of these directives supersede all corresponding
national provisions.
 New Approach directives are addressed to the Member
States, which have an obligation to transpose them into their
national legislation as appropriate.
 National laws, regulations or administrative provisions,
which transpose the directive, shall contain a reference to the
directive in question or shall be accompanied by such a reference
on the occasion of their official publication.
 National laws, regulations or administrative provisions,
which are adopted and published in order to transpose a
directive, must be communicated to the Commission.
New Approach directives approximate the laws of Member
States in order to remove barriers to trade. Since New
Approach directives are total harmonisation directives,
Member States must repeal all contradictory national legisrequirements
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
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 obligation
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).
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
12
(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.
Directive Number of Directive, Date of End of transitional
(as referred to in this Guide) Amendment application period
1. Low voltage equipment (12) 73/23/EEC 19/8/74 1/1/97
93/68/EEC 1/1/95 1/1/97
2. Simple pressure vessels 87/404/EEC 1/7/90 1/7/92
90/488/EEC 1/7/91
93/68/EEC 1/1/95 1/1/97
3. Toys 88/378/EEC 1/1/90
93/68/EEC 1/1/95 1/1/97
4. Construction products 89/106/EEC 27/6/91
93/68/EEC 1/1/95 1/1/97
5. Electromagnetic compatibility 89/336/EEC 1/1/92 31/12/95
92/31/EEC 28/10/92
93/68/EEC 1/1/95 1/1/97
(98/13/EC) (13) 6/11/92
6. Machinery (14) 98/37/EC 1/1/93 31/12/94
1/1/93 31/12/94
1/1/95 31/12/96
1/1/95 1/1/97
98/79/EC 7/6/00
7. Personal protective equipment 89/686/EEC 1/7/92 30/6/95
93/68/EEC 1/1/95 1/1/97
93/95/EEC 29/1/94
96/58/EC 1/1/97
8. Non-automatic 90/384/EEC 1/1/93 31/12/02
weighing instruments 93/68/EEC 1/1/95 1/1/97
9. Active implantable 90/385/EEC 1/1/93 31/12/94
medical devices 93/42/EEC 1/1/95 14/6/98
93/68/EEC 1/1/95 1/1/97
10. Gas appliances 90/396/EEC 1/1/92 31/12/95
93/68/EEC 1/1/95 1/1/97
11. Hot water boilers 92/42/EEC 1/1/94 31/12/97
93/68/EEC 1/1/95 1/1/97
12. Civil explosives 93/15/EEC 1/1/95 31/12/02
13. Medical devices 93/42/EEC 1/1/95 14/6/98
98/79/EC 7/6/00 30/6/01
Table 1/2 • New Approach directives (directives providing for the CE marking) •
1.5. New 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.
❝ Introduction ❞
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.
Directive Number of Directive, Date of End of transitional
(as referred to in this Guide) Amendment application period
14. Potentially explosive 94/9/EC 1/3/96 30/6/03
atmospheres
15. Recreational craft 94/25/EC 16/6/96 16/6/98
16. Lifts 95/16/EC 1/7/97 30/6/99
17. Refrigeration appliances 96/57/EC 3/9/99
18. Pressure equipment 97/23/EC 29/11/99 29/5/02
19. Telecommunications 98/13/EC 6/11/92
terminal equipment (15) 1/5/92
1/1/95
20. In vitro diagnostic 98/79/EC 7/6/00 7/12/03
medical devices 7/12/05
21. Radio and telecommunications 99/5/EC 8/4/00 7/4/00
terminal equipment (16) 7/4/01
Table 1/2 • New Approach directives (directives providing for the CE marking) • (continued)
Directive Number of Directive Date of End of transitional
(as referred to in this Guide) application period
1. Packaging and 94/62/EC 30/6/96 31/12/99
packaging waste (17)
2. High speed rail systems 96/48/EC 8/4/99
3. Marine equipment 96/98/EC 1/1/99
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 •
Draft Directive Number of proposal,
Amendment
1. Articles of precious metal COM/93/322 final
COM/94/267 final
2. Cableway installations designed to carry passengers COM/93/646 final
3. Marking of packaging COM/96/191 final
4. Noise emission COM/98/46 final
Table 1/4 • Proposals for directives based on the principles of the New Approach
or the Global Approach •

New Approach directives apply to products
which are intended to be placed (or put into
service) on the Community market (19). Usually
such products are ready for use, or
require only adjustments that can be performed
in view of their intended use. Further,
the directives apply only when the
product is placed (and put into service) on
the Community market for the first time.
Consequently, the directives apply also to
used and second-hand products imported
from a third country when they enter the
Community market for the first time, but not
to such products already on the Community
market (20). This applies even to used and
second-hand products imported from a
third country that were manufactured
before the directive became applicable.
The concept of product varies between
New Approach directives (21). The objects
submitted to the directive are referred to,
for instance, as products, equipment, apparatus,
devices, appliances, instruments,
material, assemblies, components or safety
components, units, fittings, accessories
or systems. It is the responsibility of the
manufacturer to verify whether or not the
product is within the scope of a directive
(22).
A combination of products and parts,
which each comply with applicable directives,
does not always have to comply as a
whole. However, in some cases, a combination
of different products and parts
designed or put together by the same person is considered
as one finished product which, as such, has to comply with
the directive. In particular, the manufacturer of the combination
is responsible for selecting suitable products to
make up the combination, for putting the combination
together in such a way that it complies with the provisions
of the directives concerned, and for fulfilling all the requirements
of the directive in relation to the assembly, the EC
declaration of conformity and CE marking. The decision
whether a combination of products and parts needs to be
considered as one finished product has to be taken by the
manufacturer (22) on a case-by-case basis.
A product, which has been subject to important
changes that aim to modify its original performance,
purpose or type after it has been put into service, may be
considered as a new product. This has to be assessed on a
case-by-case basis and, in particular, in view of the objective
of the directive and the type of products covered by the
directive in question. Where a rebuilt or modified product is
considered as a new product, it must comply with the provisions
of the applicable directives when it is placed on the
market and put into service. This has to be verified – as
deemed necessary according to the risk assessment – by
applying the appropriate conformity assessment procedure
laid down by the directive in question. In particular, if the risk
assessment leads to the conclusion that the nature of the
hazard or the level of risk has increased, then the modified
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.
2. Scope of New Approach directives
2.1. Products submitted to directives
 New Approach directives apply to products which are
intended to be placed (or put into service) on the Community
market for the first time. Consequently, the directives apply to
new products manufactured in the Member States, and to new,
as well as used and second-hand, products imported from
third countries (18).
 The concept of product varies between New Approach
directives, and it is the responsibility of the manufacturer to
verify whether or not the product is within the scope of one or
more directives.
 Products that have been subject to important changes may
be considered as new products that have to comply with the
provisions of the applicable directives when placed on the
Community market and put into service. This has to be
assessed on a case-by-case basis, unless otherwise provided
for.
 Products, which have been repaired without changing the
original performance, purpose or type, are not subject to
conformity assessment according to the New Approach
directives.
 Products specially or exclusively intended for military or
police purposes are explicitly excluded from the scope of
certain New Approach directives. For the other directives,
Member States may, under certain conditions, exclude from
their field of application according to Article 296 of the EC
Treaty, products intended specifically for military purposes.
The person who carries out important changes to the product
is responsible for verifying whether or not it should be
considered as a new product.
Products which have been repaired (for example following
a defect), without changing the original performance,
purpose or type, are not to be considered as new products
according to New Approach directives. Thus, such products
need not undergo conformity assessment, whether or not
the original product was placed on the market before or
after the directive entered into force. This applies even if the
product has been temporarily exported to a third county for
the repair operations. Such operations are often carried out
by replacing a defective or worn item by a spare part, which
either is identical, or at least similar, to the original spare
part (for example modifications may have taken place due
to technical progress, or discontinued production of the old
part). Thus, maintenance operations are basically excluded
from the scope of the directives. However, at the design
stage of the product the intended use and maintenance
must be taken into account (23).
Some New Approach directives explicitly exclude products
that are specially or exclusively intended for military or
police purposes (24). For other directives Article 296 of the EC
Treaty may be taken into consideration, unless the product according
to its definition cannot be used for military purposes
(such as toys, recreational craft and refrigeration appliances).
Article 296(1) of the EC Treaty offers Member States the possibility
of excluding from the application of Community legislation
products intended for specifically military purposes, insofar
as the products concerned appear in the list drawn up by
the Council according to Article 296(2), and provided such exclusion
may not have an adverse effect on the competition
conditions in the Community market concerning products that
are not specifically intended for military purposes.
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
16
(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
be designed and manufactured in accordance
with all applicable directives, as well
as to undergo the conformity assessment
procedures according to all applicable
directives, unless otherwise provided for.
Certain directives make a direct reference
to the application of other directives
(for example the Directive relating to lifts
refers to the Directives relating to machinery,
and the Directive relating to telecommunications
terminal equipment to the
Directive relating to low voltage equipment).
Although such a reference has not been
included in a number of directives, the general
principle of simultaneous application
still applies where the essential requirements
of the directives are complementary
to each other.
Two or more directives can cover the
same product or hazard. In such a case, the
application of other directives is often limited
by excluding certain products from the field of application
of the other directives, or by giving preference to the
more specific directive. This usually requires a risk analysis
of the product, or sometimes an analysis of the intended
purpose of the product, which then determines the applicable
directive. In specifying the hazards related to a product,
the manufacturer may be assisted by the risk assessment
performed by the standards bodies in relation to harmonised
standards for the product in question. Taking into
account the dominant hazards of the product this risk analysis
may lead to the publication of such standards under only
one of the possibly applicable directives (25).
2.2. Simultaneous application of directives
2.2.1. New Approach directives
 Essential requirements set up by New Approach directives
may overlap or complement each other, depending on the hazards
covered by these requirements that are related to the
product in question.
 The placing on the market and putting into service can only
take place when the product complies with the provisions of
all applicable directives, and when the conformity assessment
has been carried out in accordance with all applicable
directives.
 Where the same product or hazard is covered by two or more
directives, the application of other directives can sometimes
be excluded following an approach that includes a risk analysis
of the product with a view to intended use as defined by the
manufacturer.
New Approach directives cover a wide range of products
and hazards, which both overlap and complement each
other. As a result several directives may have to be taken
into consideration for one product, since the placing on the
market and putting into service can only take place when
the product complies with all applicable provisions.
Hazards covered by the essential requirements of the
directives concern different aspects that in many cases
complement each other (for example the Directives relating
to electromagnetic compatibility and pressure equipment
cover phenomena not covered by the Directives relating to
low-voltage equipment or machinery). This calls for a joint
application of the directives. Accordingly, the product has to
❝ Scope of New Approach directives ❞
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.
Consumer products outside the field of application of
New Approach directives and other Community legislation
(for example products not complying with the definition laid
down by the directive in question, used and second-hand
products that were originally placed on the Community market
before the directive entered into force, and repaired
products) come under the Directive on general product
safety, where they are supplied in the course of commercial
activity.
New Approach directives do not contain any system for
rapid exchange of information between market surveillance
authorities in emergency situations, with the exception of
the vigilance system included in the directives relating to different
types of medical devices. Therefore, the provisions
concerning the procedure for rapid exchange of information
on dangers, and the subsequent action at Community level
are applicable to consumer products covered by New
Approach directives (26).
The Directive on general product safety contains
detailed provisions on market surveillance (Articles 5 and
6). These provisions are not directly applicable in sectors
covered by New Approach directives, but they provide a
model for obligations and powers that are necessary for
carrying out market surveillance, in particular as regards
consumer products.
The Directive on general product safety
(92/59/EEC) aims to ensure that consumer
products placed on the market do not present
a risk under conditions of use that are
normal or can be reasonably foreseen. It
requires producers to place only safe products
on the market, and to inform about
risks. It also obliges Member States to survey
products on the market, and to inform
the Commission about actions taken
through either a safeguard clause procedure
or the information system for serious
and immediate risks. The Directive on general product safety
covers new, used and reconditioned products intended
for consumers or likely to be used by consumers, supplied
in the course of commercial activity. According to this definition,
products within the scope of several New Approach
directives are to be considered as consumer products
(such as toys, recreational craft, refrigeration appliances,
and to certain extent electrical equipment, gas appliances,
machinery, personal protective equipment and pressure
equipment).
The Directive on general product safety is applicable
insofar as there are no specific provisions in rules of Community
law governing all the safety aspects of the products
concerned. Further, where specific rules of Community law
contain provisions governing only certain aspects of product
safety or categories of risk for the product concerned,
these provisions are applicable to the products in question
with regard to the relevant safety aspects or risks. This rule
gives priority to the application of New Approach directives
for all aspects of product safety and categories of risk they
cover. Further, for products covered by New Approach
directives the objective has been to cover all foreseeable
risks, if necessary by means of simultaneous application of
these directives and other relevant provisions of Community
legislation.
2.2.2. New Approach directives and the Directive on general
product safety
 The Directive on general product safety applies to consumer
products supplied in the course of commercial activity,
provided that:
* the product is not covered by New Approach directives or
other Community legislation; or
* not all aspects of safety or categories of risk are covered by
New Approach directives or other Community legislation.
the manufacturer, the importer and the distributor to supply
safe products in order to avoid the costs that liability places
on them for defective products causing damages to individual
or property. Consequently, New Approach directives and
the Directive on product liability are complementary elements
in ensuring an adequate level of protection (27).
The objective of New Approach directives is
to protect the public interest (for example
health and safety of persons, consumer protection,
protection of business transactions,
environmental protection). Thus, they
intend to prevent, as far as possible, the placing on the market
and putting into service of unsafe or otherwise non-compliant
products. The Directive on product liability
(85/374/EEC), which is applicable to all products covered
by New Approach directives, provides a powerful incentive
to guarantee the safety of products. It is in the interest of
2.2.3. New Approach directives and the Directive on product liability
 The Directive on product liability is applicable to all
products covered by New Approach directives.
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
18
(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,
product on the Community market (31). The
transfer may also take place directly from
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 importation),
or is in a free zone (34);
 manufactured in a Member State with a
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
from third countries – whether new or used – must meet the
provisions of the applicable directives when made available
for the first time on the Community market. Member States
have an obligation to ensure this in the framework of market
surveillance (36). Used products, which are on the Community
market, are subject to free movement according to the
principles laid down by Articles 28 and 30 of the EC Treaty.
2.3. Placing on the market and putting into service
 Placing on the market is the initial action of making a product
available for the first time on the Community market, with
a view to distribution or use in the Community. Making available
can be either for payment or free of charge.
 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.
2.3.1. Placing on the market (29)
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
market refers to each individual product, not to a type of
product, and whether it was manufactured as an individual
unit or in series.
The transfer of the product takes place either from the
manufacturer, or the manufacturer’s authorised representative
in the Community, to the importer established in the
Community or to the person responsible for distributing the
❝ Scope of New Approach directives ❞
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
 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.
2.3.2. Putting into service (37)
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
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
The aim of the transitional period is to allow
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
in force in each Member State, but also to
all national specifications applied voluntarily by manufacturers.
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
2.4. Transitional period
 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.
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).
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
20
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
The manufacturer is any natural or legal person
who is responsible for designing and
manufacturing a product with a view to placing
it on the Community market under his
own name (48). The responsibilities of the
manufacturer apply also to any natural or
legal person who assembles, packs,
processes, or labels ready-made products
with a view to their being placed on the
Community market under his own name.
Further, the responsibility of the manufacturer
is placed on any person who changes
the intended use of a product in such a way
that different essential requirements will
become applicable, or substantially modifies
or re-builds a product (thus creating a
new product), with a view to placing it on the
Community market (49).
The manufacturer may design and manufacture
the product himself. As an alternative,
he may have it designed, manufactured,
assembled, packed, processed or labelled with a
view to placing it on the Community market under his own
name, and thus presenting himself as a manufacturer.
Where subcontracting takes place, the manufacturer must
retain the overall control for the product and ensure that he
receives all the information that is necessary to fulfil his
responsibilities according to the New Approach directives.
The manufacturer who subcontracts some or all of his activities
may in no circumstances discharge himself from his
responsibilities, for example to an authorised representative,
a distributor, a retailer, a wholesaler, a user or a subcontractor.
The manufacturer has sole and ultimate responsibility
for the conformity of the product to the applicable directives,
whether he designed and manufactured the product
himself or is considered as a manufacturer because the
product is placed on the market under his name.
He is responsible:
 for designing and manufacturing the product in accordance
with essential requirements laid down by the directive(
s); and
 for carrying out conformity assessment in accordance
with the procedure(s) laid down by the directive(s).
The manufacturer is obliged to understand both the
design and construction of the product to be able to take
the responsibility for the product being in compliance with
all provisions of the relevant New Approach directives. This
applies equally to situations where the manufacturer
designs, manufactures, packs and labels the product himself,
as to situations where some or all of these operations
are carried out by a subcontractor.
As regards conformity assessment, the manufacturer’s
responsibility depends on the procedure applied (50). As a
general rule, the manufacture must take all measures necessary
to ensure that the manufacturing process assures
compliance of the products, to affix the CE marking to the
product, to establish a technical documentation and to draw
up the EC declaration of conformity. Depending on the
directive, the manufacturer may be required to submit the
product to a third party (usually a notified body) for product
testing and certification, or to have the quality system certified
by a notified body. In addition, several directives set
up complementary obligations (such as the requirement to
accompany the product with specified information).
Directives usually require that the manufacturer is identified
on the product, for example on a marking on the product
or the accompanying documentation (51). However,
sometimes it is not possible to identify the person who, in
reality, was in charge of designing and manufacturing the
product. Unless otherwise provided for, this does not
reduce the responsibilities of the person who placed the
product on the Community market (for example any natural
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
3. Responsibilities
3.1. Manufacturer
3.1.1. New Approach directives
 A manufacturer, in the meaning of New Approach, is the person
who is responsible for designing and manufacturing a
product with a view to placing it on the Community market on
his own behalf.
 The manufacturer has an obligation to ensure that a product
intended to be placed on the Community market is designed
and manufactured, and its conformity assessed, to the essential
requirements in accordance with the provisions of the
applicable New Approach directives.
 The manufacturer may use finished products, ready-made
parts or components, or may subcontract these tasks. However,
he must always retain the overall control and have the
necessary competence to take the responsibility for the
product (47).
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.
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
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 manufacturer’s 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).
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
22
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
instance, be appointed to ensure and declare that the product
complies with the requirements, to affix the CE marking
and the notified body’s number to the product, to draw up
and sign the EC declaration of conformity, or to keep the
declaration and the technical documentation at the disposal
of national surveillance authorities (57).
The tasks that may be delegated to the authorised
representative according to the directives are of an
The manufacturer may be based in the Community
or elsewhere. In either case, the
manufacturer may appoint an authorised
representative in the Community to act on
his behalf in carrying out certain tasks
required in the applicable directives. However,
a manufacturer established outside
the Community is not obliged to have an
authorised representative, although this
may present some advantages (56).
For the purposes of New Approach
directives, to be able to act on behalf of the
manufacturer, the authorised representative
must be established inside the Community.
Commercial representatives of the manufacturer
(such as authorised distributors),
whether or not established inside the Community,
are not to be confused with the authorised representative
in the meaning of New Approach directives.
The delegation of tasks from the manufacturer to the
authorised representative must be explicit and should take
place in writing, in particular to define the contents of the
tasks and the limits of the representative’s powers. Depending
on the conformity assessment procedure and the directive
in question, the authorised representative can, for
3.2. Authorised representative
 The manufacturer may appoint any natural or legal person to
act on his behalf as an authorised representative (55).
 For the purposes of New Approach directives the authorised
representative must be established inside the Community.
 The authorised representative is explicitly designated by
the manufacturer, and he may be addressed by the authorities
of the Member States instead of the manufacturer with regard
to the latter’s obligations under the New Approach directive in
question.
 The manufacturer remains generally responsible for actions
carried out by an authorised representative on his behalf.
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).
❝ Responsibilities ❞
23
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
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).
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).
3.3. Importer/person responsible for placing on the
market
 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 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-
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
3.4. 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.
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.
The distribution conditions (for example transportation
or storage) may have an impact on maintaining the compliance
with the provisions of the applicable directive. This
may, for instance, be the case for measuring instruments
and medical devices. Thus, the person in charge of the distribution
conditions shall take the necessary measures to
protect the compliance of the product. This is to ensure that
the product complies with the essential requirements at the
moment of first use within the Community.
The distribution conditions may, in the absence of Community
legislation, be regulated to some extent on the
national level in accordance with Articles 28 and 30 of the
EC Treaty. National legislation that grants to members of a
specific profession the exclusive right to distribute certain
products is capable, insofar as it restricts sales to certain
channels, of affecting the possibilities of marketing imported
products. Accordingly, such legislation may constitute a
measure having an effect equivalent to a quantitative restriction
on imports. However, it can be justified for instance on
grounds of the protection of public health, if the measure is
appropriate for the purpose and does not go beyond what
is necessary to achieve it (61).
New Approach directives do not foresee that the distributor
would take over the responsibilities of the manufacturer.
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
due care and ensured that the manufacturer, or his authorised
representative in the Community, or the person who
provided him with the product has taken the necessary
measures required by the applicable directives. The distributor
must also be able to identify the manufacturer, his
authorised representative in the Community, the importer or
the person who has provided him with the product in order
to assist the surveillance authority in its efforts to receive
the EC declaration of conformity and the necessary parts of
the technical documentation.
According to the Directive on general product safety the
distributor is defined as any professional in the supply chain
whose activity does not affect the safety properties of a
product. The Directive requires distributors to act with due
care in order to help to ensure compliance with the general
safety requirement of the Directive, in particular by not supplying
products that they know or should have presumed,
on the basis of the information in their possession and as
professionals, not to comply with this requirement. In particular,
within the limits of their activities, they must participate
in monitoring the safety of products placed on the market,
especially by passing on information on product risks
and cooperating in the action taken to avoid these risks.
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
24
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
provision of the applicable directives at the moment of first
use within the Community.
Some products can only be used after an
assembly, an installation or other manipulation
has been carried out. This may, for
instance, be the case for machinery, personal
protective equipment, measuring instruments,
gas appliances and telecommunications
terminal equipment (63).
Where the directive in question covers
putting into service (64), and where an
assembly, an installation or other manipulations
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 requirements.
This is to ensure that the product complies with the
3.5. Assembler and installer
 The installer and assembler of a product, which is already
placed on the market, should take necessary measures to
ensure that it still complies with the essential requirements at
the moment of first use within the Community. This applies to
products where the directive in question covers putting into
service, and where such manipulations may have an impact on
the compliance of the product.
❝ Responsibilities ❞
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
employer is required, before choosing the personal protective
equipment, to assess that it satisfies the requirements.
According to the Directive on the minimum safety and
health requirements for work with display screen equipment
(90/270/EEC), employers are obliged to perform an analysis
of workstations in order to evaluate the safety and health
conditions, particularly regarding possible risks to eyesight,
physical problems and problems of mental stress. The
Directive also lays down the minimum requirements for the
display screen and other equipment.
According to the Directive on the introduction of measures
to encourage improvements in the safety and health of
workers at work (89/391/EEC), workers have a general
responsibility to take care, as far as possible, of their own
safety and health and that of other persons affected by their
acts at work. In accordance with the training and the
instructions given by their employer they must, for instance,
make correct use of machinery, apparatus, and other
means of production, and the personal protective equipment.
Directives 89/391/EEC, 89/655/EEC, 89/656/EEC
and 90/270/EEC lay down minimum requirements. Therefore,
Member States are allowed to adopt or retain more
stringent provisions, as long as they are compatible with the
EC Treaty. The provisions of New Approach directives must
be respected and, thus, additional national provisions may
neither request a modification of a product within the scope
of a New Approach directive, nor influence the conditions of
the placing on the market of such products.
Many products covered by New Approach
directives are used at the workplace.
According to directives based on Article
138 of the EC Treaty (65), employers have
obligations as regards the use of work
equipment at the workplace. An employer is
considered to be any natural or legal person
who has an employment relationship with a
worker (that is any person employed by an
employer), and has responsibility for the
undertaking or establishment.
According to the Directive concerning the minimum
safety and health requirements for the use of work equipment
by workers at work (89/655/EEC, modification
95/63/EC), the employer must take all measures necessary
to ensure that the work equipment (for example
machinery and apparatus) made available to the workers is
suitable for the work carried out, and may be used by workers
without impairment to their safety or health. The employer
may only obtain or use work equipment that complies
with the provisions of the applicable directives, or, if no
other directive is applicable or is only partially applicable,
the minimum requirements laid down in the annex to the
Directive 89/655/EEC. The employer must also take the
necessary measures to ensure that work equipment is kept
at such a level. Further, the employer has an obligation to
provide information and training for workers as regards the
use of work equipment.
According to the Directive concerning the minimum
health and safety requirements for the use of personal protective
equipment by workers at the workplace
(89/656/EEC), such equipment must comply with the relevant
Community provisions on design and manufacture with
respect to safety and health (that is the New Approach
Directive relating to personal protective equipment). Further,
the equipment must be appropriate for the risk involved, correspond
to existing conditions at the workplace, take into
account ergonomic requirements and the worker’s state of
health, fit the wearer correctly, and be compatible where
more than one equipment must be used simultaneously. The
3.6. User (employer)
 New Approach directives do not lay down obligations for
users, apart from those related to putting into service.
 Community legislation concerning the health and safety of
the workplace has an impact on the maintenance and use of
products covered by New Approach directives that are used at
the workplace.
The Directive on product liability covers all
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,
3.7. Product liability
 The Directive on product liability covers any product manufactured
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.
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 producer’s
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 Directive’s regime is added to the existing
national rules on liability. It is up to victim to choose on what
grounds to file the action.
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
26
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.
A fundamental principle of the New
Approach is to limit legislative harmonisation
to the essential requirements that are
of public interest. These requirements deal
in particular with the protection of health
and safety of users (usually consumers and
workers) and sometimes cover other fundamental
requirements (for example protection
of property or the environment).
Essential requirements are designed to
provide and ensure a high level of protection.
They either arise from certain hazards
associated with the product (for example physical and
mechanical resistance, flammability, chemical, electrical or
biological properties, hygiene, radioactivity, accuracy), or
refer to the product or its performance (for example provisions
regarding materials, design, construction, manufacturing
process, instructions drawn up by the manufacturer),
or lay down the principal protection objective (for example
by means of an illustrative list). Often they are a combination
of these. As a result, several directives may be applicable
to a given product at the same time, since essential
requirements of different directives need to be applied
simultaneously in order to cover all relevant public interests.
Essential requirements must be applied as a function of
the hazard inherent to a given product. Therefore, manufacturers
need to carry out risk analysis to determine the
essential requirement applicable to the product. This analysis
should be documented and included in the technical
documentation (71).
Essential requirements define the results to be attained,
or the hazards to be dealt with, but do not specify or predict
the technical solutions for doing so. This flexibility allows
manufacturers to choose the way to meet the requirements.
It allows also that, for instance, the materials and product
design may be adapted to technological progress. Accordingly,
New Approach directives do not necessitate regular
adaptation to technical progress, since assessment of
whether requirements have been met or not are based on
the state of technical know-how at a given moment.
The essential requirements are set out in annexes to the
directives. Although no detailed manufacturing specifications
are included in the essential requirements, the degree
of detailed wording differs between directives. The wording
is intended to be precise enough to create, on transposition
into national legislation, legally binding obligations that can
be enforced, and to facilitate the setting up of mandates by
the Commission to the European standards organisations in
order to produce harmonised standards. They are also formulated
as to enable the assessment of conformity with
those requirements, even in the absence of harmonised
standards or in case the manufacturer chooses not to apply
them (72).
27
4. Compliance with directives (69)
4.1. Essential requirements
 Essential requirements lay down the necessary elements for
protecting the public interest.
 Essential requirements are mandatory. Only products
complying with essential requirements may be placed on the
market and put into service (70).
 Essential requirements must be applied as a function of the
hazards inherent to a given product.
(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),
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).
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.
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
28
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
1. A mandate is drawn up, following consultation with the Member States.
2. 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.
Table 4/1 • Standardisation procedure under the New Approach •
❝ Compliance with directives ❞
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
bility for conformity assessment without the intervention of
a third party or for a larger choice of procedures (85).
According to certain directives, national standards may
give a presumption of conformity – as a transitional measure
– insofar as there is no harmonised standard covering
the same area (86). Member States may communicate to
the Commission the text of those national standards, which
they consider to meet the essential requirements. After consulting
the Committee under Directive 98/34/EC and, if provided
for, the sectoral Committee, the Commission notifies
the Member States whether or not the national standard
should enjoy presumption of conformity. If the opinion is
positive, Member States are required to publish references
of such standards. The reference is also published in the
Official Journal. This procedure has not been used so far in
order to give full priority to the development of European
standards.
Harmonised standards provide a presumption
of conformity with the essential requirements
(84), if their reference has been published
in the Official Journal and if they have
been transposed at national level. However,
it is not necessary that transposition takes
place in all Member States before the presumption
of conformity becomes effective.
Since European standards have to be transposed
in a uniform way, a manufacturer may
choose any of the corresponding national
standards.
The objective of publishing the reference
in the Official Journal is to set the earliest
date for the presumption of conformity
to take effect. Before the Commission publishes
the reference, it may verify that the
terms of the mandate are fulfilled. When it
considers that a standard does not meet
the terms of the mandate, it will either not
publish the reference of this standard, or it
will limit publication of the reference to parts
of this standard. In such cases, the condition
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.
The application of harmonised standards that give a presumption
of conformity remains voluntary (83).The manufacturer
can choose whether or not to refer to harmonised
standards. However, if the manufacturer chooses not to follow
a harmonised standard, he has the obligation to prove
that his products are in conformity with essential requirements
by the use of other means of his own choice (for
example by means of any existing technical specifications).
If the manufacturer applies only a part of a harmonised standard
or the applicable harmonised standard does not cover
all the essential requirements, the presumption of conformity
exists only to the extent the standard corresponds to the
essential requirements.
Compliance with harmonised standards will, according
to certain directives, determine the applicable conformity
assessment procedure, which sometimes opens the possi-
4.3. Presumption of conformity
 Conformity with a national standard that transposes a
harmonised standard, whose reference has been published,
confers a presumption of conformity with the essential
requirements of the applicable New Approach directive that
is covered by such a standard (81).
 References (such as titles, identification numbers) of harmonised
standards are published in the Official Journal for the
directive in question. An updated list of references for each
directive can be found at the following Internet address:
http://europa.eu.int/comm/dg03/directs/dg3b/newapproa/
eurstd/harmstds/index.html (82).
 Member States must publish the reference of the national
standard that transposes a harmonised standard. It is useful to
indicate in the publication the link with the legislation in
question.
 The application of harmonised standards, which give a presumption
of conformity, remains voluntary in the field of New
Approach directives. Thus, the product may be manufactured
directly on the basis of the essential requirements (83).
* In the light of the committee’s opinion, the Commission
shall inform the Member States who shall take necessary
measures.
New Approach directives contain a clause
according to which a harmonised standard
can be challenged (87).
* Where a Member State or the Commission
considers that a harmonised standard
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,
giving reasons for doing so.
* The committee shall deliver an opinion without delay.
4.4. Withdrawal of the presumption of conformity
 The Commission withdraws the presumption of conformity,
if it has been established that the harmonised standard does
not fully meet the essential requirements.
* 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.
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
30
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 http://www.
NewApproach.org
(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
national level of the revised harmonised standard, and the
date of withdrawal of the old standard. The transitional period
is normally the time period between these two dates.
During this transitional period both harmonised standards
give presumption of conformity, provided that the conditions
for this are met. After this transitional period, only the
revised harmonised standard gives a presumption of conformity.
The Commission may consider that, for safety or other
reasons, the old version of the harmonised standard must
cease giving a presumption of conformity before its date of
withdrawal, set by the European standards organisation in
question. In such cases, the Commission fixes an earlier date
after which the standard will no longer give a presumption of
conformity, and publishes this information in the Official Journal.
If circumstances allow, the Commission consults the
Member States prior to taking a decision to reduce the period
during which the standard gives a presumption of conformity.
The reference of the revised harmonised standard, the
reference of the old harmonised standard, and the date
when the presumption of conformity of the old standard
finishes are published together in the Official Journal.
The formal decision to revise a standard is,
in principle, taken by the European standards
organisations. This takes place on the
basis of their own initiative (89), or following
a request from the Commission directly or,
indirectly, based on an initiative of a Member
State. The need for revision can result
from the changes of the scope of the directive
(such as an extension of the scope to
other products or a modification of the
essential requirements), from the fact that
the Commission or a Member State challenges
the contents of the harmonised standard, indicating
that it could no longer give presumption of conformity with
the essential requirements, or as a result of technological
development.
When a harmonised standard is revised, the revision
must be covered by a mandate to maintain the possibility of
giving presumption of conformity. Unless the contrary can
be deduced from the original mandate, the terms and conditions
of the original mandate apply also for the revision of
the harmonised standard. This does not exclude the possibility
of a new mandate, in particular where the revision is
related to shortcomings with respect to the essential
requirements.
To give presumption of conformity, the revised standard
must satisfy the general conditions according to the New
Approach: the standard is based on a mandate, it is presented
by the relevant European standards organisation to
the Commission, its reference is published by the Commission
in the Official Journal, and it is transposed as a national
standard.
Following its internal regulations, the relevant European
standard organisation lays down the date of publication at
4.5. Revision of harmonised standards
 The principles concerning the mandate and the adoption of
harmonised standards, their availability, and the presumption
of conformity to the essential requirements apply also to the
revised version of harmonised standards.
 During the transitional period, both the old and the revised
standards give presumption of conformity, provided that the
conditions for this are met by both standards.
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 existence
or non-existence of third parties), the
types and importance of production to ensure a high degree
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
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.
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,
5. Conformity assessment procedure
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.
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
32
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 manufacturer’s
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.
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.
A Internal control of production Covers internal design and production control. This module does not require
a notified body to take action.
B EC type-examination 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.
C Conformity to type 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.
D Production quality assurance 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.
E Product quality assurance 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.
F Product verification 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.
G Unit verification Covers the design and production phases. Each individual product is examined
by a notified body, which issues a certificate of conformity.
H Full quality assurance 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 5/1 • Basic modules •
MANUFACTURER
MODULE A
MODULE C
MODULE D
MODULE E
MODULE F
MODULE G
MODULE H
MODULE B
DESIGN PHASE PRODUCTION PHASE
Table 5/2 • Simplified flow chart of conformity assessment procedures •
❝ Conformity assessment procedure ❞
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.
Additional elements compared to basic modules
Aa1 and Cbis1 Internal production control, and one Intervention of a notified body either at design or
or more tests on one or more specific production stage regarding testing carried out by the
aspect of the finished product manufacturer or on his behalf. The products concerned
and the applicable tests are specified in the directive.
Aa2 and Cbis2 Internal production control, and product Intervention of a notified body regarding product checks
checks at random intervals at production stage. The relevant aspects of the checks
are specified in the directive.
Dbis Production quality assurance A technical documentation is required.
without use of module B
Ebis Product quality assurance A technical documentation is required.
without use of module B
Fbis Product verification A technical documentation is required.
without use of module B
Hbis Full quality assurance with A notified body analyses the design of a product or a
design control product and its variants, and issues an EC design
examination certificate.
Table 5/3 • Variants of basic modules •
solutions that will ensure fulfilment of the essential
requirements;
 the identified standards or other technical solutions must
be used as design input, and as verification that design output
ensures that the essential requirements will be met;
 the measures taken by the organisation to control production
must ensure that the products conform to the identified
safety requirements;
 the organisation in its measurement and control of the
The modules based on quality assurance
techniques (modules D, E, H and their variants)
describe the elements a manufacturer
must implement in his organisation in order
to demonstrate that the product fulfils the
essential requirements of the applicable
directive. This means that a manufacturer is
given the possibility of using an approved
quality system for the purpose of demonstrating
compliance with regulatory requirements,
thus having the capability to design
(if applicable), manufacture and supply products
that fulfil the applicable essential
requirements.
A quality system implemented on the
basis of the EN ISO 9001, 9002 or
9003 (94) standard gives a presumption of
conformity with the respective modules with
regard to the provisions in the modules that
these standards cover, and provided that
the quality system enables the manufacturer
to demonstrate that the products fulfil the
essential requirements of the directive in
question. This means that the manufacturer
must specifically address regulatory needs
when implementing and applying a quality
system for the purpose of the New Approach directives, in
particular:
 the quality objectives, quality planning, quality manual and
control of documents must fully take on board the objective
of delivering products that conform to the essential requirements;
 the manufacturer must identify and document the essential
requirements that are relevant for the product and
the harmonised standards to be used or other technical
5.2. Application of quality system standards
 The use of quality systems for the purpose of conformity
assessment procedures in the directives is described in modules
D, E and H and their variants.
 Compliance with standards EN ISO 9001, 9002 and 9003
gives a presumption of conformity with the corresponding
quality assurance modules as regards the provisions covered
by the standard in question, provided that the quality system
takes into consideration — as necessary — the specific
requirements of the products for which they are implemented.
 Compliance with modules D, E, H and their variants does
not require a certified quality system according to standards
EN ISO 9001, 9002 or 9003, although it provides a useful means
of establishing compliance. The manufacturer is free to apply
other quality system models than those based on EN ISO 9000
standards for the purpose of complying with these modules.
 For the purpose of complying with the applicable directives
the manufacturer shall ensure that the quality system is implemented
and applied in such a way that it ensures the full application
of the essential requirements in question.
production process and finished products must identify and
use methods which are identified in standards or other
appropriate methods to ensure that the essential requirements
are met; and
 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
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
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).
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
34
(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
product on the Community market must
take on this responsibility (99).
The contents of the technical documentation
are laid down, directive by directive,
in accordance with the products concerned.
As a rule, the documentation should cover
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
technical point of view, for demonstrating the conformity of
the product to the essential requirements of the relevant
directive or, if the harmonised standards have been applied,
to these instead by indicating the essential requirements
covered by the standards.
Several directives require that the technical documentation
is written in an official language of the Member State
where the procedures are to be carried out, or in which the
notified body is established, or in a language accepted by
it (100). In order to carry out the conformity assessment procedures
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.
5.3. Technical documentation
 The manufacturer must draw up a technical file (technical
documentation).
 The technical documentation is intended to provide information
on the design, manufacture and operation of the product.
New Approach directives oblige the manufacturer to draw
up technical documentation containing information to
demonstrate the conformity of the product to the applicable
requirements. This documentation may be part of the quality
system documentation where the directive provides for a
conformity assessment procedure based on a quality system
(modules D, E, H and their variants). This obligation
begins when the product is placed on the market, whatever
its geographical origin is (97).
The technical documentation must be kept for at least
10 years from the last date of manufacture of the product,
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
vides for any other duration (102). This is the responsibility
of the manufacturer or the authorised representative
New Approach directives impose an obligation
on the manufacturer, or the authorised
representative established within the Community,
to draw up an EC declaration of conformity
when the product is placed on the
market. Depending on the procedure, the
EC declaration of conformity must either
ensure that the product satisfies the essential
requirements of the applicable directives,
or that the product is in conformity
with the type for which a type-examination
certificate has been issued and satisfies the
essential requirements of the applicable
directives (101).
The EC declaration of conformity must
be kept for at least ten years from the last date of manufacture
of the product, unless the directive expressly pro-
5.4. EC declaration of conformity
 The manufacturer or the authorised representative established
within the Community must draw up an EC declaration
of conformity as part of the conformity assessment procedure
provided for in the New Approach directives.
 The EC declaration of conformity should contain all relevant
information to identify the directives according to which it is
issued, as well as the manufacturer, the authorised representative,
the notified body if applicable, the product, and where
appropriate a reference to harmonised standards or other
normative documents.
established within the Community. In some cases the
importer or the person responsible for placing on the
market must take on this responsibility (99).
The contents of the EC declaration of conformity are
laid down, directive by directive, in accordance with the
products concerned. The standard EN 45014 has been
drawn up with the objective of providing the general criteria
for the declaration of conformity, and it can also be used as
a guidance document in view of New Approach directives.
According to the standard the declaration may take the
form of a document, a label or equivalent, and should contain
sufficient information to enable all products covered by
it to be traced back to it.
As a minimum the following information should be provided:
 the name and address of the manufacturer or the authorised
representative issuing the declaration;
 the identification of the product (name, type or model
number, and any relevant supplementary information, such
as lot, batch or serial number, sources and numbers of
items);
 all relevant provisions complied with;
the referenced standards or other normative documents
(such as national technical standards and specifications) in
a precise, complete and clearly defined way;
 all supplementary information that may be required (for
example grade, category), if applicable;
 the date of issue of the declaration;
signature and title or an equivalent marking of authorised
person (103); and
 the statement that the declaration is issued under the
sole responsibility of the manufacturer and, if applicable,
the authorised representative.
Other useful information to be included in the EC declaration
of conformity is the name, address and identification
number of the notified body when it has been involved in the
conformity assessment procedure, as well as the name and
address of the person who keeps the technical documentation.
Where several New Approach directives apply to a product,
the manufacturer or the authorised representative can,
basically, merge all the declarations into a single document.
However, this is not possible if the directive provides for a
specific form of the EC declaration of conformity (such as
the Directive relating to personal protective equipment).
Consequently, the EC declaration should also provide information
on whether or not it covers only one directive. In
such a case the declaration should include a reference to
other directives in order to verify whether the manufacturer
has followed all the Community legislation, or which legislation
has been chosen during the transitional period.
The EC declaration of conformity must be made available
to the surveillance authority immediately upon request.
Moreover, Directives relating to machinery, gas appliances,
potentially explosive atmospheres, recreational craft, lifts
and high-speed rail systems require that products are
accompanied by the EC declaration of conformity.
The EC declaration of conformity must be drawn up in
one of the official languages of the Community. If the Community
directives contain no further provisions concerning
the language of the declaration, the requirements of the
Member States to use a specific language must be
assessed according to Articles 28 and 30 of the EC Treaty
on a case by case basis. However, for products, which are
required to be accompanied by the declaration of conformity,
it has to be in the official language of the country of use.
In these situations a translation should be provided by the
manufacturer, the authorised representative or the distributor.
Additionally, a copy of the declaration in the original
language should be supplied.
❝ Conformity assessment procedure ❞
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).
Notified bodies (104) take responsibilities in areas of public
interest and, therefore, should remain answerable to the
competent national authorities. To be eligible a body must
be a legal entity established on the territory of the Member
State and, thus, come under its jurisdiction. Otherwise
Member States remain free to decide whether or not to notify
a body which complies with the requirements laid down in
the directives and Decision 93/465/EEC.
Since notification falls within the discretion of Member
States, they are not obliged under Community law to notify
all the bodies demonstrating technical competence. Further,
Member States are not obliged to notify bodies in
respect of each procedure to be applied according to a specific
directive. Even so, they cannot prohibit the placing on
the market of products which have been subject to one of
the conformity assessment procedures set up by a directive
and which a body notified by another Member State has
certified. This is due to the fact that Member States have
an obligation to transpose each conformity assessment
procedure established in the directive into their national
legislation.
Member States take the final responsibility for the
competence of the notified bodies vis-à-vis
the other Member States and the Community
institutions. Therefore, they must verify
the competence of the bodies seeking notification.
This shall be based on the criteria
laid down in the applicable directive in conjunction
with essential requirements and the
conformity assessment procedure in question.
In general, the competence criteria set
out in the directives cover:
 availability of personnel and equipment;
 independence and impartiality in relation
to those directly or indirectly concerned
with the product (such as the designer, the
manufacturer, the manufacturer’s authorised
representative, the supplier, the
assembler, the installer, the user);
 technical competence of personnel that
is relevant to the products and conformity
assessment procedure in question;
 maintenance of professional secrecy and
integrity; and
 subscription to civil liability insurance,
unless that liability is covered by the state
under national law.
The assessment of the body seeking notification will
determine if the body fulfils the requirements. Accreditation
according to the EN 45000 series of standards is a support
to the technical part of notification and, although it is not a
requirement, it remains an important and privileged instrument
for evaluating the competence, impartiality and
integrity of the bodies to be notified (105). Further, accreditation
should be considered by national notifying authorities
as the most favoured technical basis for the assessment in
order to reduce differences in the criteria applied for notification.
It falls within the discretion of the notifying Member
State to decide whether or not assessment carried out by a
competent accreditation body established in another Member
State is taken into consideration (106).
The EN 45000 series cover different types of conformity
assessment bodies (certification bodies, testing laboratories,
inspection bodies and accreditation bodies). It is
irrelevant whether the body calls itself a laboratory, a certification
body or an inspection body as long as it carries out
the tasks in the conformity assessment procedure and has
technical ability to do so in an independent and impartial
way.
36
6. Notified bodies
6.1. Principles of notification
 Notified bodies carry out the tasks pertaining to the conformity
assessment procedures referred to in the applicable
New Approach directives when a third party is required.
 Member States are responsible for their notification. They
may choose the bodies they notify from the bodies under their
jurisdiction which comply with the requirements of the directives
and the principles laid down in Decision 93/465/EEC.
 The assessment of the body seeking notification determines
if it is technically competent and capable of carrying out the
conformity assessment procedures in question, and if it can
demonstrate the necessary level of independence, impartiality
and integrity. Further, the competence of the notified body
should be subject to surveillance, which is carried out at
regular intervals and follows the practice established by the
accreditation organisations.
 The EN 45000 series of standards and accreditation are
important instruments to help in establishing conformity with
the requirements of the applicable directive.
(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.
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
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).
❝ Notified bodies ❞
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.
Certification bodies Testing laboratories Inspection bodies
Criteria for accreditation bodies EN 45010 EN 45002 EN 45010
EN 45003
Accreditation and EN 45010 EN 45002 EN 45010
assessment criteria EN 45003
Operational criteria EN 45011 EN 45001 EN 45004
EN 45012
EN 45013
Table 6/1 • The EN 45000 series of standards relevant for notified bodies •
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)
B EN 45004 (EN 45001 to be observed for testing required), or
EN 45011 (EN 45001 to be observed for testing required)
Cbis1, Cbis2 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)
D, Dbis EN 45012 (+ product related knowledge)
E, Ebis EN 45012 (+ product related knowledge)
F, Fbis 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)
G EN 45004 (EN 45001 to be observed for testing required), or
EN 45011 ((EN 45001 to be observed for testing required)
H EN 45012 (+ product related knowledge)
Hbis EN 45012 + EN 45004 or
EN 45011
Table 6/2 • Relevant standards of the EN 45000 series for each module •
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
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
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.
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
38
Quality system
certification involves
the assessment,
determination of
conformity against
quality system
standard and within a
certain scope of
activity and
surveillance of the
supplier’s 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.
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 management
of the lists of notified bodies, and it
does not confer rights or commit the Commission
in any way.
Member States should designate their
bodies within three months of the number
being allocated. Once this deadline has
expired the Commission can take back the
number allocated to the body.
Official notification of a body takes
place when all the information required (109)
and the identification number allocated
beforehand to each body is sent — normally
by the national administration responsible
for the implementation and management of
the directive in question — via the Permanent
Representation to the Commission (Secretariat-General)
and to the other Member States (via their Permanent
Representations). The notification takes effect after it has
been sent to the Commission and the other Member States.
The Commission ensures that a consolidated list of notified
bodies is regularly kept up to date. The Commission
has this list published for information purposes in the Official
Journal of the European Communities (C series).
Amendments or reductions of the scope, modifications of
the validity of the notification and reduction or cancellation
of the notification will likewise be published in the same
form. The Member States should also publish at the
6.2. Notification procedure and withdrawal of
notification (108)
 Notification is an act to inform the Commission and the other
Member States that a body, which fulfils the requirements, has
been designated to carry out conformity assessment according
to a directive.
 The Commission publishes a list of notified bodies in the
Official Journal of the European Communities for information
purposes. The list is constantly updated and can be obtained
directly from the Commission services.
 Withdrawal of notification takes place when the notified
body ceases to fulfil the requirements or its obligations. Withdrawal
is the responsibility of the notifying Member State. It
can also be the end result of an infringement procedure.
6.2.1. Notification procedure
Member States are free to notify a body at any time
after the directive has been adopted. To put the transitional
periods provided for in the directives to effective use so that
certificates may be granted as from the date of first application,
Member States should consider the possibility of
ensuring a mechanism by which to notify bodies before formal
transposition. In such a case notified bodies are not,
however, entitled to issue certificates before the directive is
in force.
Notification requires that the Commission has allocated
an identification number to the body. Each body receives a
national level the information concerning all notified bodies
(those they notify as well as those notified by other Member
States).
6.2.2. Withdrawal of notification
The Commission and the Member States have the responsibility
to act when doubt arises about the competence of a
notified body, either at the moment of notification or thereafter.
Should the Commission consider, on its own initiative
or after complaint, that a notified body does not comply with
the requirements or fulfil its responsibilities, it will inform the
national notifying authority and ask for appropriate documented
evidence concerning the basis for the notification or
the maintenance of the competence of the body. Should a
Member State not provide such information, the Commission
may bring this to the attention of the other Member
States for discussion or initiate the procedure under Article
226 of the EC Treaty against the notifying Member State.
Apart from presenting a complaint to the Commission,
Member States may have recourse to the procedure laid
down in Article 227 of the EC Treaty, if they dispute that a
body notified by another Member State fulfils the requirements
or its obligations properly.
When a notified body ceases to fulfil the requirements or
its obligations, the Member State has to withdraw or, if
appropriate, suspend the notification after immediately contacting
the body in question. The Member State must also
have this information published, and inform the Commission
and the other Member States following a procedure similar
to that of the notification. The body in question should have
the possibility to appeal against such a decision. Whether
this appeal postpones the de-notification or not depends on
the national legislation.
The national authority in question is solely entitled to
withdraw notification. The Commission can only withdraw a
notified body from the consolidated list when the notifying
authority of a Member State itself withdraws its notification
or when, at the end of an infringement procedure under Article
226 or 227 of the EC Treaty, the Court declares a Member
State to be in infringement of a given directive and, consequently,
declares a notification to be invalid.
The withdrawal of a notification does not affect certificates
issued by the notified body until such time as demonstration
can be made that the certificates should be withdrawn.
Where a Member State withdraws its notification, it
shall take appropriate steps to ensure that another notified
body processes files of the body concerned in order to
ensure continuity.
❝ Notified bodies ❞
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.
independent of their clients and other interested parties.
The legal status of bodies seeking notification, whether they
are private or State-owned, is irrelevant as long as their
Notified bodies must keep their national
notifying authorities informed of their activities
(for example concerning the conduct of
conformity assessments, availability of
resources, subcontracting, situations of
conflicts of interest), either directly or via an
authorised body (for example the accreditation
body). They must also be prepared to
provide to their notifying authorities all information
concerning the proper implementation
of the conditions under which they were
notified, either at the request of their notifying
authorities or of the Commission.
Notified bodies have generally an obligation
to inform the other notified bodies
and the national surveillance authority about
all certificates suspended or withdrawn and,
on request, about certificates issued or
refused. They shall also provide the surveillance
authority and, according to some
directives also the competent authorities of
other Member States, with relevant information
for the purpose of market surveillance
(111). Further, notified bodies shall
provide the Commission services responsible
for administering a safeguard clause
necessary information related to the product or the conformity
assessment upon request.
Notified bodies are and must remain third parties
6.3. General responsibilities of notified bodies
 Notified bodies shall provide relevant information to their
notifying authority, the market surveillance authorities and
other notified bodies.
 Notified bodies shall operate in a competent, non-discriminatory,
transparent, neutral, independent and impartial
manner.
 Notified bodies shall employ the necessary personnel,
which has sufficient and relevant knowledge and experience
to carry out conformity assessment in accordance with the
directive in question.
 Notified bodies shall make adequate arrangements to
ensure confidentiality of the information obtained in the
course of conformity assessment.
 Notified bodies shall be adequately insured to cover their
professional activities, unless liability is assured under the
national legislation of the notifying Member State.
 Notified bodies shall participate in coordination activities
(110). They shall also take part directly or be represented in
European standardisation, or otherwise ensure that they know
the situation of relevant standards.
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).
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
40
(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.
❝ Notified bodies ❞
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.
Notified bodies are designated to assess
the conformity with the essential requirements,
and to ensure consistent technical
application of these requirements according
to the relevant procedures in the directives
concerned. The notified bodies must have
appropriate facilities that enable them to
carry out technical and administrative tasks
related to conformity assessment. They
must also apply appropriate procedures of
quality control in relation to such services
provided.
The conformity assessment procedures
have been divided into a set of separate
modules, which cannot be further
subdivided without putting into question the
coherence of the system and the responsibilities
which should lie with the manufacturer
and, where applicable, the notified bodies. This
means that a notified body must be capable of taking the
responsibility and have the competence to carry out the
conformity assessment according to a complete module
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
6.4. Notified bodies and conformity assessment
 The primary task of a notified body is to provide services
for conformity assessment on the conditions set out in the
directives. This is a service to the manufacturers in an area
of public interest.
 Notified bodies are free to offer their conformity assessment
services, within their scope of notification, to any economic
operator established either inside or outside the Community.
They may carry out these activities also on the territory of
other Member States or of third countries.
 Manufacturers are free to choose any notified body that has
been designated to carry out the conformity assessment procedure
in question according to the applicable directive.
authorised representative regarding the directive in question,
apply the conformity assessment procedure without
unnecessary burdens for the economic operators, and
refrain from proposing additional certification or marking
that has no added value (116).
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.
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
42
(117) See Section 6.3.
with the requirements laid down in the relevant
directive.
Information on subcontracting activities
and on the competence of the subcontractors
shall be available for the notifying
authority so that it can take necessary
action, and for communication without
delay to the Commission and the other
Member States on request. Compliance
with the EN 45000 series of standards
entails a presumption of conformity with
most of the requirements, as is the case
with the notified body itself.
A notified body can subcontract strictly
limited technical tasks (such as tests and
examinations), as long as these can be defined
as substantial and coherent parts of
the technical operation. The notified body
cannot under any circumstances subcontract
all of its activities, as that would make
the notification meaningless. Notified bodies
may for example subcontract tests while
continuing to assess their results and, in
particular, to validate the test report in order
to evaluate whether the requirements of the
directive are met. Similarly, subcontracting
is possible in the field of certification of quality
systems by using external persons as
auditors, provided that the notified body carries
out the evaluation of the audit results.
The subcontracted work must be carried
out according to pre-established technical
specifications setting out a detailed procedure
based on objective criteria to guarantee
total transparency. Where the body subcontracted
by the notified body is involved in the assessment
of conformity to standards, these must be used if they lay
down the procedures. If this body is involved in the assessment
of conformity to essential requirements, the procedure
followed by the notified body itself or a procedure deemed by
the notified body to be equivalent to that must be used.
The notified body shall in all cases have a direct privatelaw
contractual link with its subcontractors to ensure the fulfilling
of its general responsibilities (117). Serial subcontracting
is prohibited in order to avoid undermining the coherence
of the system and confidence in it.
The notified body remains entirely responsible for the
work carried out for it by the subcontractor. It can have its
notification withdrawn for any reason connected with its
subcontractor.
6.5. Notified bodies and subcontracting
 A notified body can have part of its work carried out by
another body on the basis of established and regularly monitored
competence.
 The body subcontracted by the notified body must be technically
competent, and display independence and objectivity
according to the same criteria and under the same conditions
as the notified body. However, notification is not necessary.
The Member State that has notified the body, which subcontracts
part of its work, must be capable of ensuring effective
monitoring of the competence of the body subcontracted by
the notified body.
 A further condition for subcontracting is that the conformity
assessment procedure can be subdivided into technical operations
and assessment operations, and that the methodology
used to carry out the technical operations is sufficiently
precise. The body subcontracted by the notified body must,
nevertheless, carry out substantial and coherent parts of
these technical operations.
 Subcontracting must be based on a contract, which makes it
possible to ensure the transparency of and have confidence in
the notified body’s operations.
 A subcontracting notified body remains responsible for all
the activities covered by the notification. Subcontracting does
not entail the delegation of powers or responsibilities. Certificates
are always issued in the name and under the responsibility
of the notified body.
 The conditions for subcontracting apply to any subcontractor
whether or not established within the Community.
The bodies acting as subcontractors for the notified bodies
need not be notified as such. Nevertheless, the notified
body must inform the Member State concerned of its intention
to subcontract certain work. Consequently, the Member
State may decide that it cannot take the overall responsibility
as a notifying authority for such an arrangement, and
withdraw or limit the scope of the notification. The notified
body shall keep a register of all its subcontracting activities,
and update it systematically.
The notified body shall ensure that its subcontractors have
the necessary competence and that they maintain this competence,
for example by carrying out regular evaluations and by
keeping itself regularly informed of the details regarding the
performance of their tasks. The notified body must also be
able to provide proof of the compliance of its subcontractors
❝ Notified bodies ❞
43
(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.
sentatives of notified bodies (119). To achieve a higher degree
of efficiency in their work the groups can set up subgroups
with a restricted number of participants to discuss specific
technical questions. The Commission is represented in the
groups. Governmental experts and representatives of the authorities
directly responsible for the effective implementation
of the directives can participate as observers in the groups.
The European standards organisations (CEN, Cenelec and
ETSI) will be represented in the groups when such issues
arise. The groups will also invite relevant European federations
or representatives of other interested parties as observers.
Where the groups of notified bodies have to treat
subjects of a confidential nature, the participation in meetings
will be restricted as deemed necessary.
The coordination of Member States is carried
out through the sectoral working
groups of governmental experts established
under the directives (118). The cooperation
of notified bodies takes place under
the authority of the relevant working groups.
Cooperation of notified bodies is established
for each New Approach directive, by
usually making use of existing structures.
Each group has a technical secretariat and
a president. The cooperation is limited to
technical problems relating to conformity
assessment in order to ensure a uniform
application of the technical provisions of the
New Approach directives.
In recognition of the fact that notified
bodies fulfil tasks delegated to them by public authorities
they must take part in coordination activities organised by
the Commission. If a body refuses to cooperate, the notification
may be withdrawn. However, the notified bodies are
not obliged to participate in meetings at European level, if
they keep themselves informed of, and apply as general
guidance, the administrative decisions and documents produced
by their group. The relevant working documents,
meeting reports, recommendations and guidelines elaborated
by the sectoral and intersectoral groups of notified
bodies or their subgroups will be circulated to all notified
bodies forming part of those groups, whether they have
taken part in the meetings or not.
The groups of notified bodies are composed of repre-
6.6. Coordination and cooperation
 A coherent application of the conformity assessment procedures
requires close cooperation between the notified bodies,
the Member States and the European Commission.
 The Commission supports the Member States in their efforts
to establish coherence between the notifying authorities
regarding, in particular, the assessment of the competence of
the bodies to be notified, the application of notification procedures
and the surveillance of notified bodies.
 The Commission, in coordination with Member States, also
ensures that cooperation is organised between the notified
bodies.
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).
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.
44
(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.
7. CE marking (120)
7.1. Principles of CE marking
 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.
 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);
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.
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
❝ CE marking ❞
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.
 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 manufacturer’s 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
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).
ments. The CE marking on the product may neither be omitted
nor be moved to the packaging or accompanying documents
on purely aesthetic grounds (128).
The CE marking symbolises conformity to essential public
interests covered by the directives in question. Therefore, it is
to be considered as essential information to Member States’
authorities as well as other relevant parties (for example distributors,
consumers and other users). Accordingly, the requirement
for visibility means that the CE marking must be
easily accessible for all parties. It could, for instance, be affixed
on the back or underside of a product. A minimum height
of 5 mm is required to ensure that it is legible (129). It shall also
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).
The CE marking may not, in principle, be
affixed until the conformity assessment procedure
has been completed to ensure that
the product complies with all the provisions
of the relevant directives. This will usually be
at the end of the production phase. This
poses no problem if, for example, the CE
marking is on a data plate that is not affixed
to the product until after the final inspection.
However, if the CE marking forms an inseparable
part of the product, or of a component,
for example by stamping or casting, the
marking can be affixed at any other stage of
the production phase, provided that the conformity
of the product is verified as appropriate
throughout the production phase.
The CE marking shall, as a rule, be
affixed to the product or to its data plate. In
addition, it can be affixed, for instance, to the packaging or
to the accompanying documents. However, it may exceptionally
be moved from the product or its data plate if this
rule cannot be followed. This would be justified where affixing
it to the product was impossible (for example on certain
types of explosives), or not possible under reasonable technical
or economic conditions, or where the minimum dimensions
could not be respected, or it could not be ensured
that the CE marking was visibly, legibly and indelibly affixed.
In such cases, the CE marking has to be affixed to the packaging,
if it exists, and to the accompanying document,
where the directive concerned provides for such docu-
7.3. 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 must be affixed visibly, legibly and indelibly
to the product or to its data plate. However, where this is not
possible or not warranted on account of the nature of the product,
it must be affixed to the packaging, if any, and to the
accompanying documents, where the directive concerned
provides for such documents.
 Where a notified body is involved in the production control
phase according to the applicable directives, its identification
number must follow the CE marking. The manufacturer or the
authorised representative established in the Community affixes
the identification number, under the responsibility of the
notified body.
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:
 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.
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).
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
46
(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.
Owners of trademarks similar to the CE
marking, that were acquired before the introduction
of the CE marking, will be protected
against expropriation since such marks will,
as a rule, not be liable to deceive market surveillance
authorities, distributors, users, consumers
or other third parties.
In view of the objectives of technical
harmonisation, markings and marks additional
to the CE marking need to fulfil a different
function from that of the CE marking.
Thus, they should provide an added
value in signifying conformity with objectives
that are different from those to which
the CE marking relates (for example environmental
aspects not covered by applicable
directives).
The affixing of legal marking (such as a protected trademark
of a manufacturer), or of acceptable certification and
other marks additional to the CE marking, is allowed to the
extent that such markings or marks do not create confusion
with the CE marking, and that they do not reduce the legibility
and visibility of the CE marking. This confusion may
either refer to the meaning or form of the CE marking (132).
Whether or not a marking or mark is confusing should be
decided from the point of view of all relevant parties likely
to come into contact with it.
7.4. CE marking and other marks
 CE marking is the only marking which symbolises conformity
to all the obligations incumbent on manufacturers for the
product as required by the applicable directives providing for
its affixing. Member States shall refrain from introducing any
reference to another conformity marking into their national
regulations, which would signify conformity with objectives
that relate to the CE marking.
 A product may bear additional markings and marks, provided
that they:
* fulfil a different function from that of the CE marking,
* are not liable to cause confusion with it, and
* do not reduce its legibility and visibility.
The CE marking replaces all mandatory conformity markings
having the same meaning, which existed before harmonisation
took place. Such national conformity markings
are incompatible with CE marking and would constitute an
infringement of the applicable New Approach directives.
When transposing the directives, Member States shall incorporate
the CE marking in their national regulations and
administrative procedures. They shall also refrain from
introducing any other conformity marking into their national
legislation that has the same meaning as the CE marking.
Enforcement of Community legislation is an
obligation on Member States: Article 10 of
the EC Treaty requires Member States to
take all appropriate measures to ensure fulfilment
of their obligation arising out of the
Treaty. Market surveillance is an essential
tool for enforcing New Approach directives,
in particular by taking measures to check
that products meet requirements of the
applicable directives, that action is taken to
bring non-compliant products into compliance,
and that sanctions are applied when
necessary.
A high level of protection is envisaged in
the New Approach directives. This requires
Member States to take all necessary measures
to ensure that products may be 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 New Approach directives,
when correctly constructed, installed and
maintained, and used in accordance with
their purpose. This implies an obligation for
Member States to organise and carry out
market surveillance, in a way that is effective and sufficiently
extensive to discover non-compliant products. This
is to protect not only the interests of consumers, workers
and other users, but also the interests of economic operators
from unfair competition.
The obligation for market surveillance is complementary
to the provisions of the New Approach directives that
require Member States to allow free movement of products
that are in compliance with the requirements. This obligation
also corresponds to the right of Member States to challenge,
under the safeguard clause, the free movement of
substantially non-compliant products (133).
The Directive relating to toys lays down provisions for
the market surveillance authority, and obliges the Member
States to send to a report the Commission every three
years (134). Other New Approach directives do not contain
special provisions on how market surveillance should be organised
and carried out in Member States. The Directive on
general product safety has a more detailed description of
the obligation of Member States to organise market surveillance
and to adopt appropriate surveillance tools. This Directive
is not applicable to products that are covered by specific
rules of Community law based on total harmonisation
containing provisions on all safety aspects, such as New Approach
directives. However, it can be used as a reference
for market surveillance carried out in the field of New Approach
directives, especially regarding consumer products.
Market surveillance is the responsibility of public authorities
(135). This is, in particular, to guarantee the impartiality
of market surveillance operations. Each Member State can
decide upon the market surveillance infrastructure, for
example there is no limitation on the allocation of responsibilities
between authorities on a functional or geographical
basis as long as surveillance is efficient and covers the
whole territory (136). As a result, the legal and administrative
market surveillance infrastructures differ from one Member
State to another. This requires, in particular, that efficient
administrative cooperation between competent national
authorities is in place so that an equivalent level of protection
can be ensured throughout the Community, in spite of
the competence for market surveillance being limited to
each Member State’s territory.
Market surveillance authorities should have the necessary
resources and powers to conduct their surveillance activities.
This is to monitor products placed on the market
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).
8. Market surveillance
8.1. Principles of market surveillance
 Market surveillance is an essential tool for the enforcement
of New Approach directives.
 The purpose of market surveillance is to ensure that the provisions
of applicable directives are complied with across the
Community. Citizens are entitled to an equivalent level of protection
throughout the single market, regardless of the origin
of the product. Further, market surveillance is important for the
interest of economic operators, because it helps to eliminate
unfair competition.
 Member States must nominate or establish authorities to be
responsible for market surveillance. These authorities need to
have the necessary resources and powers for their surveillance
activities, ensure technical competence and professional
integrity of their personnel, and act in an independent
and non-discriminatory way respecting the principle of proportionality.
 Notified bodies should, basically, be excluded from the
responsibility of market surveillance activities. This is to
avoid conflicts of interest.
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 body’s
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.
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.
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
48
(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.
moment when placed on the market and, if
relevant, when put into service (138). Basically,
market surveillance cannot take place
during the design and production stages,
that is before the manufacturer has taken
formal responsibility for the conformity of
the products, usually by affixing the CE
marking. However, this does not exclude
collaboration between the surveillance
authority and the manufacturers and suppliers
(139).
For market surveillance to be efficient,
resources should be concentrated where
risks are likely to be higher or non-compliance
more frequent, or where a particular
interest can be identified. Statistics and risk
assessment procedures can be used for
this purpose. To be able to monitor products
placed on the market, surveillance
authorities shall have the power, competence
and resources:
 to regularly visit commercial, industrial
and storage premises;
 to regularly visit, if appropriate, work
places and other premises where products
are put into service (140);
 to organise random and spot checks;
 to take samples of products, and to subject them to
examination and testing; and
 to require all necessary information (141).
8.2. Market surveillance activities
 Market surveillance involves two main stages:
* national surveillance authorities shall monitor that products
placed on the market comply with the provisions of the
applicable national legislation transposing the New Approach
directives;
* subsequently, when necessary, they shall take action to
establish conformity.
 Although market surveillance operations cannot take place
during the design and product stages, efficient enforcement
usually requires that surveillance authorities act in collaboration
with manufacturers and suppliers in order to prevent the
placing on the market of non-compliant products.
8.2.1. Monitoring of products placed on the market
 The objective of monitoring products placed on the market is
to verify that they comply with applicable directives at the moment
when placed on the market and, if relevant, when put into
service.
 The EC declaration of conformity and the technical documentation
provide the surveillance authority with necessary
information about the product.
Market surveillance authorities must monitor products
placed on the market. The aim is to find out whether or not
a product complies with the applicable provisions at the
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
❝ Market surveillance ❞
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.
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.
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
50
(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
directive are incorrectly affixed, or where
the EC declaration of conformity cannot be
provided for immediately or it does not
accompany the product when this is mandatory,
or the requirement to accompany
other information provided for in the directive(
s) is complied with insufficiently, or,
where applicable, the identification number
of the notified body has not been affixed to
the CE marking.
Non-conformity to essential requirements
must usually be considered as a substantial
non-compliance, because this may,
for instance, present a potential or actual
risk to the health and safety of citizens.
However, non-conformity to a harmonised
standard is not, as such, sufficient evidence
of non-conformity to essential requirements,
but indicates that further investigations may be necessary.
Depending on the circumstances, it may be considered
either as a non-substantial or substantial non-compliance, if
a product is not CE marked when it should be according to
the applicable directives, or a product is CE marked when it
should not be. It needs to be taken into account that the
application of a directive, and accordingly the requirement
to affix the CE marking, can sometimes prove to be difficult.
On the other hand, if a product covered by a New Approach
directive is not CE marked, it is an indication that the product
does not comply with the essential requirements or the
8.2.2. Corrective actions
 Before any action is taken, the party concerned must be notified
and — unless the matter is urgent — given the possibility
of being consulted.
 The corrective action depends on the level of noncompliance,
which has to be established on a case by case
basis, and it has to be in accordance with the principle of
proportionality:
* first, the manufacturer, or the authorised representative,
should be obliged to make the product comply with the provisions
and to remedy the infringement;
* ultimately, where other measures have failed or they are not
considered as sufficient, all appropriate measures shall be
taken to restrict or prohibit the placing on the market and putting
into service of the product in question, and to ensure that
it is withdrawn from the market.
Competent national authorities must take action to enforce
conformity, when they discover that a product is not in compliance
with the provisions of the applicable directives.
The corrective action depends on the degree of noncompliance
and, thus, must be in accordance with the principle
of proportionality. However, the difference between
non-substantial and substantial non-compliance is not
always clear, and must be decided on a case by case basis.
The incorrect affixing of the CE marking as regards, for
instance, the design, size, visibility, indelibility or legibility,
can usually be considered as a non-substantial non-compliance.
Examples of typically non-substantial non-compliance
conformity assessment procedure has not been applied
and, consequently, the product may, for instance, endanger
the health and safety of persons. Such non-compliance
should be considered as substantial.
Enforcement of conformity can be achieved by obliging
the manufacturer, the authorised representative, or other
responsible persons, to take required measures (149). Corrective
action can also take place if the necessary measures
are taken (for example the product is modified or withdrawn
from the market), either as a result of consultations
carried out by the surveillance authority or as a result of formal
or informal warnings. In all cases the surveillance
authority must establish accompanying measures to ensure
that conformity is enforced.
Action taken against non-substantial non-compliance
can be on two levels.
* First, the surveillance authority should oblige the manufacturer,
or the authorised representative, to make the product
intended to be placed on the market and, if necessary,
the product already on the market, comply with the provisions
and to remedy the infringement.
* Secondly, if no result can be achieved, the competent
authority shall, ultimately, take a further step to restrict or
prohibit the placing on the market of the product and, if necessary,
to ensure that it is also withdrawn from the market.
In case of substantial non-compliance the competent
authority has to take appropriate measures, following the
principle of proportionality, to enforce conformity.
* The authority shall, ultimately, restrict or prohibit the
placing on the market and the putting into service of the
product and ensure that it is withdrawn from the market, if
no other measures are sufficient to maintain the high level
of protection envisaged in the directives. This usually
invokes the safeguard clause.
Action to prohibit or restrict the placing
on the market may first be temporary to
allow the surveillance authority to obtain
sufficient evidence about the danger or
other substantial non-compliance of the
product.
Any decision taken by national authorities
to restrict or prohibit the placing on the
market, or the putting into service, or to
withdraw products from the market must
state the exact grounds on which it is
based. The party concerned – in particular,
the manufacturer, or the authorised representative
established in the Community –
shall be notified. They shall also be
informed about remedies available under
the national law in force in the Member State in question,
and of the time limits to which such remedies are subjected
(150).
Unless the matter is urgent (for example the product
presents a serious and immediate danger to the health and
safety of persons), the manufacturer, or the authorised representative
established in the Community, should have an
opportunity to be consulted in advance, before the competent
authority takes action to restrict the free circulation of
products. In practice, it should be considered as sufficient
when the manufacturer or the authorised representative has
been provided with an opportunity to react. However, it
should not delay the proceeding, if the manufacturer or the
authorised representative remains passive (151).
The decision to restrict the free movement of a CE
marked product in case of substantial non-compliance usually
invokes the safeguard clause procedure. This procedure
is aimed to enable the Commission to keep an
overview of such measures and to consider whether or not
they are justified. In addition, the exchange of information
between national surveillance authorities on corrective
actions taken, whether or not based on substantial noncompliance,
should take place, where this is considered
appropriate and necessary, and where the need for confidentiality
as well as transparency can be respected (152).
A manufacturer, the authorised representative, or other
person may consider himself to have suffered a loss as a
result of an inappropriate national measure that restricted
the free movement of a product. In such a case he could be
entitled to claim damages under the jurisdiction of the State
which initiated the procedure and in accordance with the
laws of that State. For instance, an opinion taken by the
Commission, at the end of a safeguard clause procedure,
where the national measure is considered as non-justified,
may raise the question whether or not a liability case for
incorrect implementation of Community law could take
place.
❝ Market surveillance ❞
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.
8.2.3. Complementary activities
 Efficient enforcement of directives usually requires that, in
addition to market surveillance operations described in
Sections 8.2.1 and 8.2.2, surveillance authorities should:
* act in collaboration with manufacturers and suppliers;
* take appropriate action against the person who has affixed
the CE marking to a non-compliant product, and against those
who are responsible for the non-compliance of the product;
and
* have the possibility to warn persons who might be at risk,
to destroy dangerous products and ban their export, to prohibit
the use of such products, and to require the withdrawal of
certificates.
Surveillance authorities should not limit their activities to
monitoring products placed on the market, and to taking
the necessary corrective actions. Informal contacts and
other collaboration between the authority and the manufacturers
and suppliers may help in preventing the placing
on the market of non-compliant products. For instance,
the authority can provide general advice and guidance to
the economic operators on the application of the directives.
Further, the authority should also consider the possibilities
of raising the awareness of consumers and other
users, for example on issues relevant to their health and
safety.
New Approach directives require that action is taken
against persons who affix the CE marking to non-compliant
products (153). Action should, as well,
be taken against the manufacturer (or
other person) responsible for placing a
non-compliant product on the market.
These actions can, for instance, consist of
warnings or legal proceedings. Actions
must also be considered against the notified
body, if it was involved in the conformity
assessment procedure that had, as
a result, non-compliant products. In such
cases, the competence of the notified
body may need to be assessed as well.
Since New Approach directives do not
specify any penalty, Member States remain
free to choose the sanctions to be used
when infringements take place. These
penalties must be analogous to those applicable
to infringements of national law of a
similar nature and importance. In addition,
these penalties must be effective, proportionate
and dissuasive (154).
Usually some products from the same
product series will have already been sold
or even put into use after the non-compliance
has been discovered. In these cases,
it is important to ensure that persons who
might be exposed to a risk from a product
are informed. This should basically be considered
as a responsibility of the manufacturer
or the distributor, in particular as
regards consumer products (155). The warning
can take the form of a general publication
or, if the number of persons at risk is
limited, it can be directed to individuals. The
authority should also consider whether or
not it would be necessary to restrict the use of products
that have proven to be dangerous.
When a competent authority decides to restrict or prohibit
the placing on the market and the putting into service
of a product, or to withdraw it from the market, it should
also consider — in accordance with the principle of proportionality
— whether or not it would be necessary to destroy
the product, or ban its export to other Member States, and
to require the withdrawal of certificates. Sometimes it is
also important to verify whether or not decisions need to be
taken for other products which have the same technical fea-
8.3.1. Conditions for invoking the safeguard clause
The safeguard clause is designed to allow the Commission
to analyse the justification of national measures restricting
the free movement of CE marked products (products presumed
to comply with requirements). Secondly, it provides
a means to inform all national surveillance authorities about
dangerous products, and, accordingly, to have the necessary
restrictions extended to all Member States so as to
ensure an equivalent level of protection throughout the Community.
The safeguard clause shall be applied to products that
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
52
(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.
8.3. Safeguard clause procedure
 New Approach directives include a form of safeguard
clause, which obliges Member States to restrict or forbid the
placing on the market and the putting into service of dangerous
– or, according to some directives, otherwise non-compliant –
products, or to have them withdrawn from the market (156).
 As a general rule, this safeguard clause procedure is
restricted to products which are:
* covered by New Approach directives;
* CE marked; and
* ascertained by the Member State to present a substantial
hazard, even if the products are correctly constructed,
installed and maintained, and used according to their intended
purpose.
 This safeguard clause procedure shall be applied to national
measures which:
* restrict or forbid the placing on the market of a product, or
have a product withdrawn from the market;
* relate to all products belonging to the same batch or series;
and
* have binding legal effects.
 The Member State must notify the Commission immediately
after taking action that invokes the safeguard clause. The necessary
information and evidence to justify the action must
accompany the notification.
 If the Commission considers the national action to be justified,
it informs the other Member States. They are required to
take the necessary measures on their territory.
tures as those subject to market surveillance actions, in
order to ensure a high level of protection.
New Approach directives may require the competent
authority to take special action regarding non-compliant
products. For instance, the directive relating to telecommunications
terminal equipment requires Member States to
disconnect equipment from the public telecommunication
network if it is not used for the intended purpose.
fall within the scope of a New Approach directive and bear
the CE marking provided by such a directive. Consequently,
the safeguard clause cannot be applied to products that are
not CE marked in accordance with the directive providing
for the safeguard procedure in question (157).
For the safeguard clause to be applicable, the non-conformity
has to be established regarding a systematic failure
in the design of a whole series of products manufactured,
however limited the series. For an isolated error, limited to
the territory of the Member State that has discovered the
non-compliance, there is no need to invoke the safeguard
clause, since there is no need to take action on Community
level.
The application of the safeguard clause requires that the
competent national authority decides to restrict or forbid
the placing on the market and, possibly, the putting into
service of the product, or has it withdrawn from the market.
The contents of the decision should relate to all products
belonging to the same batch or series. It must also have
binding legal effect: it is followed by sanctions, if not
respected, and can be subject to an appeals procedure.
Court decisions, which restrict the free movement of CE
marked product within the scope of the relevant directive(s),
do not invoke the safeguard clause. However, where administrative
proceedings initiated by the surveillance authority
must be, according to the national law, confirmed by a
court, such court decisions are not excluded from the safeguard
clause procedure.
Conformity can be enforced if the national authority requests
the manufacturer or the authorised representative to
take the necessary measures, or if the product is modified
or voluntarily withdrawn from the market. Unless a formal
decision is taken in these cases, to prohibit or restrict the
placing on the market of the product or to have it withdrawn
from the market, the safeguard clause procedure is not invoked.
Thus, a direct exchange of information between market
surveillance authorities may be necessary (158).
The findings that justify the national measure are established
either by the market surveillance authority on its own
initiative, or based on information received from a third
party (such as consumers, competitors, consumer organisations,
labour inspectorates). Further, the national measure
must be based on evidence (for example tests or examinations)
that constitutes sufficient proof of errors in the
product design or the manufacture to indicate a foreseeable
potential or actual danger or other substantial non-compliance,
even when the products are correctly constructed,
installed, maintained and used in accordance with their
intended purpose or in a reasonably foreseeable way. There
is a grey zone between correct and incorrect maintenance
and use, and it can be considered that, to a certain extent,
products should be safe, even if maintained and used with
their intended purpose in an incorrect way that can reasonably
be expected (159). In evaluating this, the data supplied
by the manufacturer on the labelling, in the instructions, in
the user’s manual or in promotion materials are to be taken
into consideration (160).
The reason for invoking the safeguard clause may
result, for instance, from differences or failures in the application
of essential requirements, incorrect application of
harmonised standards or shortcomings in them. The surveillance
authority can add or specify other motives (for
example failure to comply with good engineering practice)
when invoking the safeguard clause, provided that they are
directly linked with these three reasons.
Where non-compliance with harmonised standards that
give a presumption of conformity is established, the manufacturer,
or the authorised representative in the Community,
must be requested to provide evidence about compliance
with essential requirements. The decision of the competent
authority to take corrective action must always be based on
an established non-compliance with the essential requirements
invoking the application of the safeguard clause.
8.3.2. Notification to the Commission
As soon as a competent national authority restricts or forbids
the free movement of a product in such way that the
safeguard clause is invoked, the Member State must immediately
notify the Commission indicating the reasons and
justification for the decision (161). At this stage, the Commission
does not distribute the information it has received.
The safeguard clause does not include an obligation to
inform the other Member States (162). In several sectors
Member States tend to send a copy of their notification to
other Member States (163). Member States that have
received such a notification from another Member State
should decide if action is necessary, and take into account
that such action must be justified.
To reduce the time taken to process the file by the Commission,
the notification should include:
 a reference to the directive(s), and in particular to the
essential requirements, against which the non-compliance
has been established;
 name and address of the manufacturer, the authorised
representative, and in addition – if necessary – the name
and address of the importer or other person responsible for
placing the product on the Community market;
 a copy of the declaration of conformity;
 the name and number of the notified body that intervened
in the conformity assessment procedure, if applicable;
 information on the procedure which was used by the
authority to verify the compliance of the product; and
 a comprehensive assessment and evidence to justify the
measure (for example harmonised standards or other technical
specifications used by the authority, the test reports
and identification of the testing laboratory).
Where the manufacturer, the authorised representative,
or other responsible person, agrees to modify the product
❝ Market surveillance ❞
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
in such a way that it complies with the applicable provisions,
the Member State should withdraw the safeguard clause
notification.
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,
research institutes or scientific experts).
Although these consultations can be relatively
wide, the urgency of the problem is
taken into account and the procedure is
kept as short as possible.
At the end of the consultation procedure,
the Commission takes an opinion on
the justification of the national measure that
restricted or prohibited the free movement
of products.
Where the Commission considers in its
opinion that the action is justified, it informs
the Member State concerned and the other
Member States immediately. The Commission
may also decide to publish this opinion. Consequently,
Member States have an obligation to take appropriate
action, with a view to the opinion of the Commission, to
ensure a similar level of protection throughout the Community.
This requirement is based on the general obligation of
Member States for market surveillance and for enforcement
of Community legislation. If a Member State refuses to follow
the position taken by the Commission, the Commission
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.
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
54
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.
8.4. Protection of CE marking
 Market surveillance authorities must check that the affixing
and use of the CE marking is correct, and that the principles
regarding additional markings and marks are respected.
 Where necessary, the authority has to take appropriate
corrective action to protect the CE marking.
 A Member State must notify to the Commission and to the
other Member States when it decides to restrict free movement
due to incorrect affixing of the CE marking, or when it
takes action against those who are responsible for a noncompliant
product bearing the CE marking.
Member States must provide in their national legislation for
appropriate measures both to prevent the abuse and misuse
of CE marking, and to redress the situation if such
abuse or misuse takes place.
The affixing of the CE marking to a product that is not
covered by any of the directives providing for its affixing is
considered to be deceiving because consumers or users,
for instance, are likely to get the impression that the
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 authorities
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.
❝ Market surveillance ❞
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.
vent, restrict or impose specific conditions on the possible
marketing or use of consumer products presenting a serious
and immediate risk. A further condition for invoking
RAPEX is that the effects of the risk can go beyond the territory
of the Member State concerned. Member States are
not required, as is the case under the safeguard clause procedure
according to the New Approach directives, to provide
evidence to justify the national measure. The Commission
verifies that the information complies with the provisions
of the Directive on general product safety, and will
pass it to the other Member States.
Where RAPEX has been applied, the Commission, after
consulting the Member States and at the request of at least
one of them, may adopt a decision requiring Member States
to take temporary measures. This is to ensure the protection
of health and safety of consumers and the proper
functioning of the single market.
The safeguard clause procedures under the New
Approach directives apply independently from RAPEX.
8.5.1. Consumer products: rapid
exchange of information
The Directive on general product safety provides
a legal basis for an information
exchange system for emergency situations.
This system for the rapid exchange of information
on dangers arising from the use of
consumer products (RAPEX) (170) is a general
and horizontal early warning and monitoring
system. It is designed for handling
urgent situations caused by new, used or
repaired products that present a serious
and immediate risk to the health and safety
of consumers. Its essential aim is to provide
information in order to allow authorities of
all Member States to take immediate and
appropriate action when a serious risk arising
from a product has been detected.
RAPEX applies to all products intended
for consumers, or likely to be used by consumers, which,
used under normal or reasonably foreseeable conditions,
present, for any reason, an immediate and serious risk to
the health and safety of consumers. It covers both foodstuffs
and industrial (non-food) products. It is also applicable
to consumer products covered by the New Approach
directives and it is, in particular, important for toys and low
voltage products. This is because the New Approach directives
do not provide for such a procedure (171).
RAPEX works according to the detailed procedures laid
down in the annex to the Directive on general product safety.
As soon as a serious and immediate risk is detected, the
national authority must consult, insofar as possible and
appropriate, the producer or distributor of the product concerned.
The authority should try to obtain the maximum of
information on the products and the nature of the danger,
without compromising the need for rapidity.
A Member State shall inform the Commission when it
adopts, or decides to adopt, emergency measures to pre-
8.5. Information exchange systems
 A rapid information exchange system has been set up by the
Directive on general product safety to handle emergency situations
caused by consumer products that present a serious
and immediate danger.
 A vigilance system applies for medical devices. This system
requires that a national surveillance authority notifies to the
Commission and to the other Member States serious performance
defects, inadequate marking or instructions that can
result in, or have resulted in, the death of patients or users, or
a serious deterioration in their health.
 Information on injuries, particularly those resulting
from home and leisure accidents, for example, caused by or
involving products, is available in the Community injury datacollection
and information-exchange system.
Accordingly, RAPEX does not necessarily have to come into
play before the safeguard clause procedure is applied. However,
the safeguard clause procedure has to be applied, in
addition to RAPEX, when the Member State takes a decision
to permanently prohibit or restrict the free movement of CE
marked products on the basis of a danger or other serious
risk presented by the product.
8.5.2. Medical devices: vigilance system
Risks posed by medical devices have necessitated a comprehensive
monitoring system whereby all serious product
incidents will be reported (172). The medical devices vigilance
system applies to all incidents which might lead to, or
might have led to, the death of a patient or a user, or to a
serious deterioration in their state of health, and which
result from:
 any malfunction or deterioration in the characteristics or
performance of a device;
 any inadequacy in the labelling or the instructions for use;
or
 any technical or medical reason in relation to the characteristics
or performance of a device, and which leads the
manufacturer to systematically recall all devices of the
same type.
The manufacturer is responsible for activating the vigilance
system and must, accordingly, inform the surveillance
authority about incidents that invoke it. After the notification,
the manufacturer is obliged to make investigations,
send a report to the surveillance authority and consider, in
collaboration with the authority, what action should be
taken.
The manufacturer’s notification is followed by an
assessment carried out by the surveillance authority, if possible
together with the manufacturer. After the assessment,
the authority must immediately inform the Commission, and
the other Member States, of the incidents for which relevant
measures have been taken or are contemplated. The Commission
may then take any steps to coordinate, facilitate
and support measures taken by the national surveillance
authorities when dealing with the same type of incidents, or,
if necessary, take measures at Community level (for example
envisaging the re-classification of the device).
A databank containing, among other information, data
obtained in accordance with the vigilance system will be set
up and made accessible to the competent authorities.
The vigilance system is different from the safeguard
clause procedure, since it requires notification even if the
manufacturer takes the necessary measures on a voluntary
basis. Nevertheless, when applying the vigilance system the
surveillance authority is also obliged to adopt a restrictive
measure vis-à-vis non-compliant CE marked products, if the
conditions for invoking the safeguard clause apply and,
accordingly, notify this measure following the safeguard
clause procedure. However, the vigilance system does not
necessarily have to come into play before the safeguard
clause procedure is applied.
8.5.3. Community injury data-collection and
information exchange system
The Community action programme on injury prevention within
the framework for action in the field of public health aims
to contribute to public health activities which seek to reduce
the incidence of injuries, particularly injuries caused by
home and leisure accidents (173). For this purpose the programme
promotes:
 the epidemiological monitoring of injuries by means of a
Community system for the collection of data and the
exchange of information on injuries based on strengthening
and improving on the achievements of the European home
and leisure accident surveilance system (Ehlass); and
 information exchanges on the use of those data to contribute
to the definition of priorities and better prevention
strategies.
The data is collected from hospitals and other appropriate
establishments and services within the Member States,
and by means of surveys. The collection and transmission
of data to the information system is carried out under the
responsibility of the Member States, which have an obligation
to ensure the reliability of sources.
The setting up of an on-line telematic tool for sharing
and transferring data is underway. This will facilitate direct
exchanges of information between national administrations,
Commission and international organisations.
The programme is also open to participation by the
associated countries of central and eastern Europe, and by
Cyprus and Malta.
8.5.4. Other information exchange systems at
Community level
The safeguard clause procedure, under the New Approach
directives, provides a means to exchange information,
although its primary objective is to verify whether or not the
national measure can be justified and, if this is the case, to
resolve the problem at Community level. In addition, the
New Approach directives oblige Member States to inform
the Commission, and the other Member States, when free
circulation is restricted due to incorrect affixing of the CE
marking, or action has been taken against those who are
responsible for a non-compliant product bearing the CE
marking.
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
56
(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.
❝ Market surveillance ❞
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.
communicate to the Commission any information they consider
relevant, spontaneously or in response to a reasoned
request from the Commission. The Commission may then
communicate this information to the other national authorities
when considered necessary.
Information exchange has been set up in Community legislation
to a limited extent, mainly where a risk of a serious
danger is present (175). For instance, the safeguard clause of
the New Approach directives is, basically, only applicable to
CE marked products, and all non-consumer products as well
as minor non-compliance are excluded from the application
of the rapid information exchange system according to the
Directive on general product safety. In some circumstances,
the existing information exchange systems are not quick
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.
8.6.1. Outline for administrative
cooperation
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).
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
practical problems.
Administrative cooperation calls for mutual trust and
transparency between national surveillance authorities.
Member States and the Commission need to be informed
about the way enforcement of New Approach directives, in
particular market surveillance of products covered by the
New Approach, is organised throughout the single market.
This includes information about national authorities in charge
of market surveillance for the different product sectors, and
about national market surveillance mechanisms to clarify
how monitoring of products placed on the market takes
place and what corrective actions and other activities the
surveillance authority is entitled to use. Transparency is also
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
8.6. Administrative cooperation
 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.
Cooperation and mutual assistance are, in particular,
necessary to ensure that action can be taken against all
those who are responsible for a non-compliant product
being placed on the market. In such cases the authority of
the Member State, where the manufacturer, the authorised
representative, or other responsible person is established,
needs to be contacted (176). This is to obtain information
from these economic operators, for example to require the
EC declaration of conformity or some specified details from
the technical documentation, or to request information concerning
the distribution chain. The Member State under
whose jurisdiction the notified body operates needs to be
contacted as well. When a national authority acts due to
information it has received from another national body, it
should report back to this authority on the outcome of the
action.
Moreover, market surveillance would be more efficient,
on the Community level, if the national surveillance authorities
could agree on how to allocate their resources in such
a way that a maximum number of different product types
could be covered in each sector. To avoid duplication of
product tests, or other investigations for market surveillance
purposes, national authorities should build up a mechanism
to exchange a summary report of these tests. National
surveillance authorities should also consider whether or
not there is special need to carry out technical analyses or
laboratory tests when another surveillance authority has
already done so, and the results are available to those
authorities or may at their request be placed at their disposal
(177). It might also be useful to exchange results of
periodic inspections on equipment in service, to the extent
that they provide information on the compliance of products
when they were placed on the market.
Information exchanged between national surveillance
authorities has to be covered by professional secrecy,
according to principles of the national legal system in question,
and it has to enjoy the protection extended to similar
information under national law. Where a Member States has
rules permitting free access by persons to information held
by surveillance authorities, this fact must be revealed at the
time of the request to another surveillance authority, or during
the exchange of information if no such request occurs.
If the sending authority indicates that the information
involves matters of professional or commercial secrecy, the
receiving authority should ensure that this can be provided
for. Otherwise the sending authority is entitled to withhold
the information.
Coordination and exchange of information between
national surveillance authorities need to be agreed by the
parties involved and taking into account the needs of the
sector concerned. The following principles could be taken
into consideration, where appropriate:
 appointing a national communication point or correspondent
for every sector, which would coordinate internally as
appropriate;
 agreement about the types of cases for which the communication
of surveillance information would serve a useful
purpose;
 developing a common approach to issues such as the
classification of risks and hazards and their coding;
 identification of the details which should be communicated
in each case, including the request for further information;
 accepting the obligation to respond to enquiries within a
given time scale (178);
 transmitting information (requests and responses), as
simply as possible, by e-mail, or through a telematic system
operated by the Commission or an external body, and by
using standard multi-language forms;
 taking advantage of up-to-date data recording techniques
so that enquiries can be easily undertaken; and
 treating the information received in complete confidence.
8.6.2. Infrastructures for administrative cooperation
Committees and working groups
Cooperation between national administrations takes place
in working groups set up under the New Approach directives.
Discussions mainly focus on interpretation issues, but
questions related to market surveillance and administrative
cooperation are also dealt with.
Administrative cooperation between national authorities
carrying out market surveillance is taking place in the following
sectors: low voltage equipment, electromagnetic
compatibility (EMC administrative cooperation), machinery
(Machex) (179), medical devices (in particular regarding the
vigilance system), telecommunications terminal equipment,
recreational craft, and consumer products (Prosafe, the
product safety forum of Europe).
The group of Senior Officials for Standardisation and
Conformity Assessment Policy is a horizontal committee
where, for instance, general questions related to the implementation
and enforcement of New Approach directives,
such as horizontal aspects of market surveillance, are
discussed.
The emergencies committees, set up under the Directive
on general product safety, regularly discusses administrative
cooperation issues of general interest.
The Internal Market Advisory Committee (IMAC) (180)
advises the Commission on all aspects concerned with the
functioning of the single market. The committee facilitates
exchange of information between the Commission and the
Member States. The committee does not intervene if other
appropriate mechanisms are in place, but it can deal with
situations that do not come within the scope of existing
mechanisms.
Data on national enforcement structures
Member States have been required to notify to the Com-
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
58
(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.
mission their respective ministries for certain priority areas
of single market legislation (181). The main aim behind this
provision is to enable governments to cooperate with each
other to enforce legislation, mainly through exchange of
information, such as data about dangerous products,
inspections and tests carried out in another Member State,
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
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
eastern European countries, the EEA EFTA
States and Cyprus.
The objectives of the programme are to develop a convergent
approach to enforcing Community legislation relating
to the single market, to raise awareness of the European
dimension, to build mutual confidence between Member
States’ administrations, and to permit cross-fertilisation of
ideas.
The Commission decides, on an annual basis, the priority
areas for the Karolus programme. These have included
conformity testing and market supervision, and in particular
the following sectors: toys; personal protective equipment;
Regulation (EEC) No 339/93 on checks for conformity with
the rules on product safety in the case of products imported
from third countries requires the customs authorities to
be closely involved in the market surveillance operations
and information systems provided for under Community and
national rules, in cases relating to products from third
countries.
Customs authorities are, in particular, requested to suspend
the release of goods 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
❝ Market surveillance ❞
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 1993–97,
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.
8.7. Products imported from third countries
 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.
low voltage electrical equipment, electromagnetic compatibility;
equipment and protective systems intended for use in
potentially explosive atmospheres; medical devices; gas
appliances; pressure vessels; chemicals; civil explosives;
machinery; motor vehicles; recreational craft; and different
quality control instruments.
safety under normal and foreseeable conditions of use. The
same applies where customs authorities find that a document
required to accompany the products is missing, or
that products do not bear conformity marking or labelling
required under Community or national rules on product
safety.
Regulation (EEC) No 339/93 applies to products
imported from third countries, whether or not covered by
New Approach directives. As regards products covered by
New Approach directives, customs authorities must be particularly
vigilant in checking that toys are CE marked, where
these can be considered as finished products that are presented
in a manner (packaging, marking, labelling) indicating
that they are to be placed on the market without further
processing (186).
Customs authorities must notify their decisions to suspend
release of a product to the market surveillance authorities,
which in turn must be in a position to take appropriate
action. Four hypotheses must be distinguished as from the
moment of the notification.
(1) The products in question present a serious and immediate
risk to health or safety.
* In this case the market surveillance authorities must take
measures to prohibit the placing on the market in accordance
with the applicable Community or national rules, and
request the customs authorities to mark the commercial
invoice accompanying the product, and any other relevant
accompanying document, with the words ‘Dangerous product
— release for free circulation not authorised — Regulation
(EEC) No 339/93’ in one of the 11 official Community
languages (187).
(2) The products in question do not comply with Community
or national rules on product safety.
* In this case the market surveillance authorities must take
appropriate measures, if necessary prohibiting the placing
on the market under the rules in question. In cases where
placing on the market is prohibited, they must ask the customs
authorities to mark the commercial invoice accompanying
the products, and any other relevant accompanying
document, with ‘Product not in conformity — release for
free circulation not authorised — Regulation (EEC)
No 339/93’ in one of the eleven official Community languages
(187).
(3) The products in question do not present a serious and
immediate risk and cannot be considered as not conforming
to the rules applicable to product safety.
* In this case the products must be released for free circulation,
provided that all the other conditions and formalities
regarding release for free circulation are met.
(4) The customs authorities have not been notified of any
action taken by the market surveillance authorities.
* In this case the products in question must be released
for free circulation, at the latest within three working days
from the suspension of release, provided that all the other
conditions and formalities regarding release for free circulation
have been met.
By virtue of several community acts — including Regulation
(EEC) No 339/93 and the Directive on general product
safety — the surveillance authorities have an obligation
to notify the customs authorities of their findings, which concern
products imported from third countries. The following
three situations may be possible.
(1) Products imported from third countries intended for consumers
or likely to be used by them present a serious and
immediate risk to health and safety according to the Directive
on general product safety.
* In this case the system for the rapid exchange of information
on dangers arising from the use of consumer products
according to the Directive on general product safety
applies to consumer products covered by New Approach
directives or other Community legislation. As a consequence,
market surveillance authorities in all Member
States are informed, and they may in turn inform the national
customs authorities about products imported from third
countries, which display characteristics giving rise to a
serious doubt as to the existence of a serious and immediate
risk to health and safety. This information is of particular
importance for customs authorities where it involves
measures banning or withdrawing from the market products
imported from third countries, based on a Commission decision
taken in accordance with Article 9 of the Directive on
general product safety (188).
(2) Products imported from third countries are not accompanied
by documents, or bear no conformity marking or
labelling as provided for by Community or national rules on
product safety.
* In this case the market surveillance authorities must
inform the customs authorities in order to draw their attention
to the existence of such products falling under the
scope of Regulation (EEC) No 339/93.
(3) Products imported from third countries, which present a
risk to health or safety that is not serious and immediate,
and are subject to measures prohibiting or restricting their
placing on the market, or imposing their withdrawal from
the market.
* In this case the Member State taking these measures
must notify them to the Commission according to the safeguard
clause procedure under the New Approach directives,
provided that the conditions for triggering such a
clause are met. Where the product is intended for consumers
or likely to be used by consumers, the safeguard
clause under the Directive on general product safety
applies, unless the product is covered by Community legislation
providing for a safeguard clause (such as the New
Approach directives). In such cases, it is necessary to
inform customs authorities.
For the purposes of applying Regulation (EEC)
No 339/93, the provisions of Council Regulation (EC)
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
60
(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.
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.
❝ Market surveillance ❞
61
9.1.1. Basic elements of the Agreement
The Agreement on the European Economic Area, in force
since 1 January 1994, covers all New Approach directives,
and other Community legislation and acquis relevant to the
free circulation of products. Hence, it extends the single
market to the so-called EEA EFTA States: Iceland, Liechtenstein
and Norway.
The objective of the EEA Agreement is to establish a
dynamic and homogeneous European Economic Area,
based on common rules and equal conditions of competition.
The Agreement is amended on a continuous basis
through decisions of the EEA Joint Committee following
changes in relevant Community legislation. To arrive at and
maintain a uniform interpretation and application of the
Agreement an EFTA Court and an EFTA Surveillance Authority
have been established.
Rights conferred and obligations imposed upon the
Member States, or their public entities, undertakings, or
individuals in relation to each other, are, according to the
EEA Agreement, understood to be conferred or imposed in
the same way also upon the EEA EFTA States. This ensures
that the EEA EFTA States, and their economic operators,
are subject to the same rights and obligations as their counterparts
in the Community. For instance, the New Approach
directives are applied in exactly the same way in the EEA
EFTA States as in the Member States — although the administrative
procedures concerning notification bodies and the
safeguard clause are modified. Therefore, all guidance
applicable to the Member States according to this Guide
applies also to the EEA EFTA States.
For the purpose of the EEA Agreement references to the
Community or the common market in the EU/EEA acts are
understood to be references to the territories of the Contracting
Parties. Accordingly, a product is not only placed
on the Community market, but on the EEA market.
The EEA Agreement ensures a close cooperation
between the Commission and the administration of the EEA
EFTA States. The Commission seeks informal advice from
experts of these States in the same way as
it seeks advice from experts of the Member
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.
9.1.2. Notification of bodies
Procedures for notification of conformity assessment bodies
from the EEA EFTA States have been established based
on provisions of the EEA Agreement. The request for allocation
of an identification number is first presented to the
EFTA Secretariat, applying the same notification form as in
the Community. The Secretariat verifies its formal correctness
and transmits the application to the Commission with
a request for an identification number (or for an extension
of the use of the identification number to new
directives/tasks). The Commission allocates the number
and communicates it via the Secretariat to the notifying
country. After this the EEA EFTA State makes a formal notification
to the other EEA EFTA States, the EFTA Surveillance
Authority and the Secretariat. The Surveillance Authority
examines the notification and informs the Commission,
which keeps an updated list of notified bodies from the
Member States and the EEA EFTA States, and publishes it
in the Official Journal.
When a notified body ceases to fulfil the requirements or
its obligations, the EEA EFTA State has the responsibility to
withdraw the notification. The Member State must also publish
this information, and inform the other EEA EFTA States,
the EFTA Surveillance Authority and the Secretariat. The
Surveillance Authority informs the Commission about the
withdrawal, which will then update the list of notified bodies.
9.1.3. Safeguard clause procedure
The EFTA Surveillance Authority is responsible for the examination
of the safeguard clause notifications from the EEA
EFTA States. The Authority consults all parties concerned
and exchanges information with the Commission on the proceedings
of the case. The Authority transmits its decision to
the EEA EFTA States and the Commission for further
actions. If an EEA EFTA State does not follow the decision,
the Surveillance Authority can initiate an infringement
procedure.
In cases where a Member State triggers a safeguard
62
9. External aspects
9.1. Agreement on the European Economic Area
 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.
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.
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
❝ External aspects ❞
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.
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.
designating these bodies and, if applicable, transitional
periods. More sectorial annexes can be added successively.
MRAs are not based on the necessity to mutually accept
other party’s standards or technical regulations, or to consider
the legislation of the two parties as equivalent. However,
MRAs can pave the way towards a harmonised system
of standardisation and certifications of the parties. Nevertheless,
the two legislations are, as a rule, deemed to
ensure a comparable level regarding the protection of
health, safety, environment or other public interests. Moreover,
MRAs increase the transparency of the regulatory systems,
since the different systems are shown to other countries
and they have to demonstrate coherence.
As a result of the different conditions established and
the interest of third countries and the Community, the Commission
was authorised in 1992 to negotiate with the following
countries: United States, Japan, Canada, Australia,
New Zealand, Hong Kong, Israel, Singapore, Philippines,
South Korea and Switzerland.
At the time of writing (May 1999), the Commission has
finalised negotiations with Australia, New Zealand, the
United States, Canada, Switzerland and Israel (192), and is
negotiating with Japan. The concluded MRAs all contain
commitments to further negotiations.
The Community in its relations with third
countries endeavours to promote international
trade in regulated products, in particular
by concluding mutual recognition
agreements (MRAs) on the basis of Article
133 of the EC Treaty.
MRAs are designed so that each party
shall accept the reports, certificates and
marks that are in accordance with its own
legislation. These are drawn up and issued
by bodies that the other party has designated
under the MRA for assessing conformity
in the field(s) covered by the MRA. This can
be achieved, because MRAs include all the conformity
assessment requirements of the parties necessary to
obtain full market access (190), and the products are evaluated
in the country of production against the regulatory
requirements of the other party.
MRAs cover the entire territory of the parties in order to
guarantee, in particular in States with a federal structure,
the full free movement of products certified to be in conformity.
As a general rule, MRAs are limited to products that
have their origin on the territory of either party (191).
MRAs apply to one or more categories of products or
sectors falling within the regulated field (they are covered
by New Approach or other Community technical harmonisation
directives in force) and, in certain cases, by nonharmonised
national law. In principle MRAs should cover all
the industrial products for which the regulations of at least
one of the parties require third party conformity assessment.
MRAs comprise a framework agreement and sectorial
annexes. The framework agreement lays down the essential
principles of a traditional agreement. Sectorial annexes
specify, in particular, the scope and coverage, regulatory requirements,
the list of designated conformity assessment
bodies, the procedures and authorities responsible for
9.2. Mutual recognition agreements
 Mutual recognition agreements are established between
the Community and the government of third countries, which
are on a comparable level of technical development and have
a compatible approach concerning conformity assessment.
 These agreements are based on the mutual acceptance of
certificates, marks of conformity and test reports issued by the
conformity assessment bodies of either party in conformity
with the legislation of the other party.
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
64
tries, to support the progressive extension
of the single market to these countries, and
to promote health and safety. The determining
factor for an ECAP is the capacity of
the applicant countries to specifically implement
the parts of the Community acquis
that are adopted in the protocol. Since
ECAPs are based on alignment to Community
rules, products assessed according to
Community legislation in a Member State or
an applicant country can be placed on the
Community market and on the market of the
applicant country.
In order to ensure the development in
terms of reciprocal openness of markets until the accession
of the applicant countries, the ECAPs are based on the conditions
necessary for the adoption and implementation of
the Community acquis as follows:
 progressive alignment of framework laws;
 progressive alignment of sectorial laws with the New
Approach directives and other directives;
 development of technical infrastructures in order to
ensure that the technical competence of the bodies involved
in the conformity assessment procedures is at the level
required by the European Union;
 setting up the necessary structures for the correct
enforcement of the acquis; and
 taking into account the need of the applicant countries to
define the procedures and means for correctly carrying out
market surveillance.
As part of the pre-accession strategy, the Commission
supports the applicant countries through technical assistance
programmes in aligning their legislation with Community
legislation. This aid is frequently completed by bilateral
assistance from Member States.
9.3. European conformity assessment protocols
 The European conformity assessment protocols are intended
to be established between the European Community and the
governments of the applicant countries of central and eastern
Europe (Hungary, Poland, the Czech Republic, Slovenia, Estonia,
Romania, Bulgaria, Slovakia, Latvia and Lithuania).
 The objective of the European conformity assessment protocols
is to support the progressive alignment of the applicant
countries with the Community acquis and the facilitation of
trade and market access.
The central and eastern European countries, which have
signed an association agreement with the Community committing
them to align their legislation with the Community
acquis, and which at the same time are applying for membership
of the European Union, have a special status. This
has provided the opportunity of designing a specific model
of mutual recognition agreements for those countries.
These are called European Conformity Assessment Protocols
(ECAP or PECA).
The ECAPs should cover the products submitted to
Community legislation, and should include all procedures
required to verify the conformity of products to this legislation.
They comprise a framework protocol and sectorial
annexes. The framework protocol adopts the essential principles
concerning mutual recognition of products, based on
the principle of the adoption of the acquis. Sectorial annexes
are added successively.
The ECAPs should be seen as a support for the alignment
process, and as an instrument of the pre-accession
strategy. At the same time they are a means to facilitate
trade between the Member States and the applicant counand
vice versa. Successful implementation
should benefit both parties in this way. The
main aims of technical assistance, therefore,
are to increase trade relationships and
investment opportunities, improve the quality
of goods on the domestic market, help
the recipient countries develop their own
infrastructure and to reinforce the human
capacity of the countries in the technical
areas.
Technical assistance programmes take place in the
fields of institutional cooperation, standardisation,
metrology, certification, accreditation, quality management
and quality assurance. These programmes are intended
for countries that are not on a comparable level
with the Member States in these fields. Since some partner
countries have reached a stage of economic and industrial
development where basic infrastructures are in
9.4. Technical assistance
 Technical assistance is the basis for creating a homogeneous,
transparent and credible technical environment in
which the public authorities, economic operators and users
can have confidence.
 Technical assistance aims to achieve the availability of high
quality products on the market.
Technical assistance is a transfer of knowledge and legislation
policies, such as the New Approach and the Global
Approach, but also a transfer of European best practice. It
enables European experience to be shared with partners
from non-member countries in all areas, with the objective of
lifting barriers to trade as a result of increased compatibility
or harmonisation on the international level, and increasing
investment from the Member States to recipient countries
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 fulfilment
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.
❝ External aspects ❞
65
published and notified via the WTO Secretariat to the other
members, who can make comments and, if necessary,
request discussions. Following these discussions, if a
technical barrier to trade persists, the disagreement may
lead to a consultation procedure and, eventually, to a
dispute settlement.
The TBT Agreement lays down obligations,
which apply to technical regulations and
conformity assessment procedures issued
either on a national or a regional basis. A
Code of Good Practice for the preparation,
adoption and application of standards has
been annexed to the TBT Agreement. WTO
Members are invited to ensure that standards
bodies accept and comply with it.
WTO Members are also encouraged, within
the limits of their resources, to actively participate
in the work of international standardisation bodies,
and to negotiate mutual recognition agreements on conformity
assessment.
Draft technical legislation deviating from international
standards and having a significant effect on trade must be
9.5. WTO Agreement on Technical Barriers to Trade
 The WTO Agreement on Technical Barriers to Trade (the TBT
Agreement) is a market access instrument, using a variety of
measures that help to prevent and eliminate technical barriers
to trade caused by technical regulations, voluntary standards
and conformity assessment procedures.

❝ Annex 1 ❞
67
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)
88/378/EEC
93/68/EEC
Council Directive of 3 May 1988 on the approximation of
the laws of the Member States concerning the safety of
toys
3.
Annex 1
Community legislation referred to in the Guide
I New Approach directives Number of Directive Reference in the OJEC
(i.e. directives providing for the CE marking) amendment amendment
(corrigendum)
1. 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
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)
2. Council Directive of 25 June 1987 on the harmonisation
of the laws of the Member States relating to simple
pressure vessels
87/404/EEC
90/488/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)
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 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
89/686/EEC
93/68/EEC
93/95/EEC
96/58/EC
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
8. Council Directive of 20 June 1990 on the harmonisation
of the laws of the Member States relating to nonautomatic
weighing instruments
90/384/EEC
93/68/EEC
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
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)
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 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
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)
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 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 ❞
68
I New Approach directives Number of Directive Reference in the OJEC
(i.e. directives providing for the CE marking) amendment amendment
(corrigendum)
15. 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
94/25/EC OJ L 164 of 30/06/94
(OJ L 127 of 10/06/95)
(OJ L 17 of 21/01/97)
16. 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
95/16/EC OJ L 213 of 07/09/95
17. 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
96/57/EC OJ L 236 of 18/09/96
18. 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
97/23/EC OJ L 181 of 09/07/97
(OJ L 265 of 27/09/97)
19. 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
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
II Directives based on the principles of the New Number of Directive Reference in the OJEC
Approach or the Global Approach, but which do amendment amendment
not provide for the CE marking (corrigendum)
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)
III Proposals for directives based on the principles Number of Directive Reference in the OJEC
of the New Approach or the Global Approach amendment amendment
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
COM/96/191 final OJ C 382 of 18/12/96
4. 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/98/46 final OJ C 125 of 22/04/1998
❝ Annex 1 ❞
69
IV Other Community directives, regulations and Number of Reference in the OJEC
decisions referred to in the Guide document amendment
amendment (corrigendum)
1. 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
85/374/EEC OJ L 210 of 07/08/85
(OJ L 307 of 12/11/88)
2. 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
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)
90/270/EEC OJ L 156 of 21/06/90
(OJ L 171 of 04/07/90)
6. Council Directive 92/59/EEC of 29 June 1992 on
general product safety
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
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)
12. Commission Decision of 28 July 1993 establishing the
list of products provided for in Article 8 of Council
Regulation (EEC) No 339/93
93/583/EEC 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
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
70
IV Other Community directives, regulations and Number of Reference in the OJEC
decisions referred to in the Guide document amendment
amendment (corrigendum)
16. 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
98/34/EC
98/48/EC
OJ L 204 of 21/07/98
OJ L 217 of 05/08/98
17. 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)
372/1999/EC OJ L 46 of 20/02/99
❝ Annex 2 ❞
71
10 5
28 30
30 36
95 100a
133 113
137, 138 118a
226 169
227 170
228 171
249 189
251 189b
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 Previous number of the article
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 Community’s 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
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
72
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.
Art. 226 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 party’s
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
Court’s 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.
❝ Annex 2 ❞
73
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 Parliament’s 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 Committee’s 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.
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
74
Annex 3
Additional guidance documents
I Documents related to
New Approach directive Number Date Language
1. Guidelines on the application of Council
Directive 73/23/EEC (electrical equipment
designed for use within certain voltage limits)
12/97 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 ES, DA, DE, EL, EN,
FR, IT, NL, PT
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
99 EN
14. Recreational craft Directive (94/25/EC) and
comments to the Directive combined
6/98 EN
15. Handbook on implementation of Conformity Assessment
Procedures relating to Directive 91/263/EEC
(telecommunications terminal equipment)
11/95 EN
❝ Annex 3 ❞
75
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
II Draft Documents related to Language
New Approach directives
1. 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 Number of Reference in the OJEC
Global Approach in general document
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
COM(89) 209 final OJ C 267 of 19/10/89
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
OJ C 112 of 07/05/90
5. 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
6. Council Resolution of 16 June 1994 on the development
of administrative cooperation in the implementation and
enforcement of Community legislation in the internal
market
OJ C 179 of 01/07/94
7. Council Resolution of 8 July 1996 on cooperation
between administrations for the enforcement of legislation
on the internal market
OJ C 224 of 01/08/1996
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
COM(98) 291 final
1. Methods of coordinating the procedures governing
the notification and management of notified
bodies
Certif. 93/1
Rev.3
DE, EN, FR
IV Certif documents related to the
New Approach or the Global Approach Number Date Language
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
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
76
14. Protocols of European conformity assessment
(PECA)
Certif. 98/8 10/8/98 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
5. Various factors to be taken into account in order
to clarify the meaning of CE marking
Certif. 96/4 5/11/96 DE, EN, FR
IV Certif documents related to the
New Approach or the Global Approach Number Date Language
7. Accreditation and the Community’s 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
V Other relevant documents
Number Date Language
1. Common standards for enterprises ISBN 92-826-
8110-6
94 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
ISBN 92-828-
2785-2
98 DE, EN, FR
❝ Annex 4 ❞
77
21. Radio and telecommunications terminal equipment
(99/5/EC)
Enterpr. G3 94157
Annex 4
Commission contact points
I New Approach directives Contact
DG 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
II Directives based on the principles of the New
Approach or the Global Approach, but which do Contact
not provide for the CE marking DG Unit Fax number (32-2) 29- ...
1. Packaging and packaging waste (94/62/EC) Environ. E3 91068
2. High-speed rail systems (96/48/EC) Enterpr. E6 56851
3. Marine equipment (96/98/EC) Transp. D3 69066
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
78
1. Articles of precious metal (COM/93/322 final, amendment
COM/94/267 final)
Enterpr. G4 66273
III Proposals for directives based on the principles Contact
of the New Approach or the Global Approach DG Unit Fax number (32-2) 29- ....
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 Contact
Guide DG Unit Fax number (32-2) 29- ....
1. Directive on product liability (85/374/EEC) Internal
market
D1 93088
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)
Enterpr. G1 53877
4. Regulation concerning checks on products imported
from third countries (EEC No 339/93)
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)
Employment
& social
affairs
D6 34259
7. 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
Enterpr.
Enterpr.
G2
F2
91675
60851
V Horizontal issues related to New Approach Contact
directives DG Unit Fax number (32-2) 29- ....
1. Conformity assessment procedures, notified bodies
(also updated lists of notified bodies), CE marking,
market surveillance
Enterpr. G1 53877
2. Standardisation Enterpr. G2 91675
2. Directive on general product safety (92/59/EEC) Health &
consumer
protection
A4 91858
❝ Annex 5 ❞
79
Annex 5
Useful web addresses
DG III Documents and publications:
http://europa.eu.int/comm/dg03/public.htm
References to harmonised standards in the context of New Approach directives:
http://europa.eu.int/comm/dg03/directs/dg3b/newapproa/eurstd/harmstds/index.html
(also access via http://www.NewApproach.org)
New Approach standardisation in the European internal market —
how to access European standards and standards activities on the web:
http://www.NewApproach.org
One stop Internet shop for business
http://europa.eu.int/business/en/topics/standards/index.html
Directive 98/13/EC
http://forum.europa.eu.int/Public/irc/dg3/tcam/info/data/inforce.html
Directive 99/5/EC
http://forum.europa.eu.int/Public/irc/dg3/tcam/info/data/welcome.html
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
80
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 New Approach Products that are as a general rule covered by the directive in question
directive
1. Low voltage equipment 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 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
3. Toys Products or material 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 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
6. Machinery Machinery 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
Safety components 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
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
❝ Annex 6 ❞
81
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)
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
8. Non-automatic weighing
instruments
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
I New Approach Products that are as a general rule covered by the directive in question
directive
10. Gas appliances Appliances 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
Fittings 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
11. Hot-water boilers Combined boiler-body units 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
Appliances i.e. the boiler-body designed to have a burner
fitted, or the burner designed to be fitted to a
boiler-body
12. Civil explosives Materials and articles considered to be explosives in the United Nations
recommendations on the transport of dangerous
goods and falling within Class 1 of those recommendations
13. Medical devices Instrument, apparatus,
appliances, materials or
other article, whether used
alone or in combination
(including the software
necessary for its proper
application)
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
Accessories 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
14. Potentially explosive
atmospheres
Equipment 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 ❞
82
Assemblies* i.e. several pieces of pressure equipment
assembled by a manufacturer to constitute an
integrated and functional whole*
I New Approach Products that are as a general rule covered by the directive in question
directive
Protective systems 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
Safety devices, controlling
devices and regulating
devices
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
15. Recreational craft Boats 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
16. Lifts 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
Safety components used in lifts and referred to in Annex IV of the
Directive
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
Piping* i.e. piping components intended for the transport
of fluids, when connected together for integration
into a pressure system
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
19. Telecommunications
terminal equipment
Equipment 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
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)
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
* provided that the
maximum allowable
pressure is greater
than 0.5 bar
❝ Annex 6 ❞
83
I New Approach Products that are as a general rule covered by the directive in question
directive
II Directive based on
the principles of
the New Approach Products that are as a general rule covered by the directive in question
or the Global Approach
Accessories i.e. an article intended specifically by its manufacturer
to be used together with others for in vitro
diagnostic examination
21. Radio and telecommunications
terminal equipment
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
2. High-speed rail system Subsystems 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
1. Packaging and packaging
waste
Products 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
Inter-operability
constituents
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
3. Marine equipment Equipment 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
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
84
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 Manufacturer or the Notified body
authorised representative
A • 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)
• 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
Aa1 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
In addition to the responsibilities
as in module A:
• affixes the notified body’s
identification number to
follow the CE marking, if the
notified body intervened
during the production stage
• 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)
Aa2 As in module A:
• applies for product checks at
random intervals
In addition to the responsibilities
as in module A:
• affixes the notified body’s
identification number to
follow the CE marking
• 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)
B • 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
• 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 ❞
85
Module Manufacturer Manufacturer or the Notified body
authorised representative
C • 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)
• 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
Cbis1 As in modules C and Aa1 As in modules C and Aa1 As in module Aa1
Cbis2 As in modules C and Aa2 As in modules C and Aa2 As in module Aa2
D • 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 body’s
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)
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
86
Module Manufacturer Manufacturer or the Notified body
authorised representative
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 As in module D
E As in module D, but operates
an approved quality system for
final product inspection and
testing
As in module D As in module D
Ebis As in module Dbis, but operates
an approved quality system for
final product inspection and
testing
As in module D As in module D
F • 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)
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
• 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 body’s
identification number to
follow the CE marking
• draws up a declaration of
conformity
• keeps relevant technical
information (e.g. the notified
body’s 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)
❝ Annex 7 ❞
87
Module Manufacturer Manufacturer or the Notified body
authorised representative
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
• 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 body’s
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 body’s certificate of
conformity at the disposal of
the surveillance authorities
As in module F
G • 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
• applies for certification of
conformity
• affixes the CE marking to
each product
• affixes the notified body’s
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)
H • 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
As in module D As in module D
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
88
Module Manufacturer Manufacturer or the Notified body
authorised representative
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
As in module D 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 ❞
89
Annex 8
Flow chart presentation of conformity assessment procedures as provided for by the
directives
I New Approach directives
II Directive based on the principles of the Global Approach, but which does not provide for the CE marking
21. Marine equipment (96/98/EC)
1. Low voltage equipment (73/23/EEC, amendment 93/68/EEC)
2. Simple pressure vessels (87/404/EEC, amendments 90/488/EEC and 93/68/EEC)
3. Toys (88/378/EEC, amendment 93/68/EEC)
4. Electromagnetic compatibility (89/336/EEC, amendments 92/31/EEC and 93/68/EEC)
5. Machinery (98/37/EC, amendment 98/79/EC)
6. Personal protective equipment (89/686/EEC, amendments 93/68/EEC, 93/95/EEC and 96/58/EC)
7. Non-automatic weighing instruments (90/384/EEC, amendment 93/68/EEC)
8. Active implantable medical devices (90/385/EEC, amendments 93/42/EEC and 93/68/EEC)
9. Gas appliances (90/396/EEC, amendment 93/68/EEC)
10. Hot water boilers (92/42/EEC, amendment 93/68/EEC)
11. Civil explosives (93/15/EEC)
12. Medical devices (93/42/EEC, amendment 98/79/EC)
13. Potentially explosive atmospheres (94/9/EC)
14. Recreational craft (94/25/EC)
15. Lifts (95/16/EC)
16. Refrigeration appliances (96/57/EC)
17. Pressure equipment (97/23/EC)
18. Telecommunications terminal equipment (98/13/EC)
19. In vitro diagnostic medical devices (98/79/EC)
20. Radio and telecommunications terminal equipment (99/5/EC)
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
90
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
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).
Technical File (Annex IV.3)
Manufacturer establishes the
technical documentation covering
the design, manufacture and
operation of the electrical equipment
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.
Module A
MANUFACTURER
❝ Annex 8 ❞
91
(*) 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.
2. Flow chart for the conformity assessment procedures provided for in
Directive 87/404/EEC on simple pressure vessels
MANUFACTURER
Function
of value PS. V
(Art. 3.2
& 8.1)
PS. V >
50 bar.L
PS. V <
50 bar.L
Compliance
with
standards
Yes
Manufacture in
accordance with
sound engineering
practice (Art. 3.2)
No CE
marking
Manufacturer’s
choice
Certification of
file adequacy
by NB
MODULE A+ (*)
EC type
examination
(Art.10)
MODULE B (*)
Value
of PS. V
PS. V >
3000 bar.L
EC Verification (Art. 11)
NB verifies and certifies SPV
conformity. Manufacturers
declare the conformity.
MODULE F (*)
EC conformity declaration,
by manufacturers,
plus EC surveillance by NB
if PS. V>200 bar.L (Art. 12).
MODULE Cbis2+
No or
partial
PS. V <
3000 bar.L
Manufacturer’s
choice
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(*) 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.
3. Flow chart for the conformity assessment procedures provided for in
Directive 88/378/EEC on the safety of toys
MANUFACTURER
Compliance
with
standards
Yes
Non-compliance,
in whole or in part
EC type-examination
(Art. 10)
MODULE B (*)
Manufacturer confirms
conformity of production with
type and keeps technical file or
technical reports inspection (Art. 8.2)
MODULE C (*)
Manufacturer keeps technical file
or technical report, ensuring
conformity of production
to standard (Art. 8)
MODULE A (*)
❝ Annex 8 ❞
93
(*) 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.
4. Flow chart for the conformity assessment procedures provided for in
Directive 89/336/EEC on electromagnetic compatibility
MANUFACTURER Type
of product
Other than
radio transmitters
Application
of harmonised
standards
Full
application
Non-application or
partial application of
harmonised standards
EC type-examination
(Art 10.5)
MODULE B (*)
EC declaration of
conformity with type
approved
MODULE C (*)
Technical construction
file (Art. 10.2)
by manufacturer
Technical report or
certificate by a
competent body (Art. 10.2)
Self certification (Art. 10.1)
MODULE A (*)
EC declaration of conformity
by manufacturer
Radio
transmitters
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
94
(*) 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.
5. Flow chart for the conformity assessment procedures provided for in
Directive 98/37/EC on machinery
MANUFACTURER
Type
of machines and
safety components
(Annex IV)
Not referred
to in Annex IV
Referred to
in Annex IV
and complying
with standards
Type
of machines and
safety components
(Annex IV)
Referred to in Annex IV,
without meeting or only
partly meeting the
standards, or if no such
standards exist
Technical file (Annex VI)
sent to notified body
Technical file (Annex VI)
submitted to NB for
certification of adequacy
for the file
EC type-examination
(Annex VI)
MODULE B (*)
EC type examination
(Annex VI)
MODULE B (*)
Technical construction
file (Annex V)
EC conformity declaration
with essential requirements
MODULE A
Conformity declaration to type
covered by the EC type examination
MODULE A
(1)
(1) Safety components do not
bear CE marking. All machines
and safety components
must be accompanied by
the EC declaration of
conformity.
❝ Annex 8 ❞
95
(*) 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.
6. Flow chart for the conformity assessment procedures provided for in
Directive 89/686/EEC on personal protection equipment (PPE)
MANUFACTURER Technical file
(Annex III)
Simple design
PPE (Art. 8.3)
Other
equipment
Type of
product
EC type-examination
(Art. 10)
MODULE B (*)
Other
equipment
Complex design
PPE (Art. 8.4a)
Type of
product
Manufacturer’s
choice
EC declaration of conformity
(EC production quality system
(Art 11B))
NB assesses and monitors
the manufacturer’s quality
system.
MODULE D (*)
EC declaration of conformity
(EC final product quality
system (Art. 11A))
NB carries out product checks
MODULE C bis2 (*)
EC declaration of conformity
to essential requirements (Art. 12)
MODULE A (*)
EC declaration of conformity
to type (Art. 12)
MODULE C (*)
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96
(*) 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.
7. Flow chart for the conformity assessment procedures provided for in
Directive 90/384/EEC on non-automatic weighing instruments
MANUFACTURER Use of
product
Art. 1.2a
Instruments
Art. 8.1a
2nd para
Manufacturer’s
choice
Manufacturer’s
choice
EC type-examination
(Annex II.1)
MODULE B (*)
Manufacturer’s
choice
Art. 1.2b
The product must bear:
• the manufacturer’s mark or name
• the maximum capacity
(Annex IV.2)
EC conformity declaration
with type (product quality
assurance - Annex II.2)
NB assesses and monitors the
manufacturer’s quality system
MODULE D (*)
EC verification (Annex II.3)
NB verifies and certifies that
products conform to type
MODULE F (*)
No CE
marking
EC unit verification (Annex II.4)
NB verifies and certifies that instrument
meets the directive requirements.
MODULE G (*)
❝ Annex 8 ❞
97
(*) 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.
8. Flow chart for the conformity assessment procedures provided for in
Directive 90/385/EEC on active implantable medical devices
MANUFACTURER
Type
of product
Art. 9
All other
devices
Custom made
devices and devices for
clinical investigations
Manufacturer’s
choice
EC type-examination
(Annex 3)
MODULE B (*)
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
manufacturer’s quality system
MODULE Hbis (*)
Manufacturer’s
choice
EC declaration of conformity
to type (production quality
assurance (Annex 5))
NB assesses and monitors the
manufacturer’s quality system
MODULE D (*)
EC verification (Annex 4)
NB verifies and certifies that
products conform to the type
MODULE F (*)
Manufacturer’s declaration
(Annex 6)
+ technical file
No CE
marking
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98
(*) 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.
9. Flow chart for the conformity assessment procedures provided for in
Directive 90/396/EEC on appliances burning gaseous fuels
MANUFACTURER
Simple design
PPE (Art. 8.3)
Other
equipment
Type of
production
EC type examination
(Annex II.1)
MODULE B (*)
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
MODULE G (*)
EC conformity declaration with
the type (Annex II.2)
NB carries out spot checks on devices
MODULE C (*)
EC conformity declaration with the type
(production quality assurance, Annex II.3)
NB assesses and monitors the manufacturer’s
quality system
MODULE D (*)
EC conformity declaration with the type
(production quality assurance, Annex II.4)
NB assesses and monitors the manufacturer’s
quality system
MODULE E (*)
EC verification (Annex II.5)
NB verifies and certifies that products
conform with the type
MODULE F (*)
Manufacturer’s
choice
Fittings don’t bear
CE marking, but they are
accompanied by a certificate.
(1)
(1)
❝ Annex 8 ❞
99
Note: the Directive provides in Article 6 for a label system awarding the boilers energy performances.
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
MANUFACTURER
Gas-fired
boilers
Liquid-fired boilers,
series production
Type of
production
EC type-examination
(Annex III)
MODULE B
Gas-fired boilers are submitted to conformity
assessment procedures provided for in
Directive 90/396/EEC, appliances burning
gaseous fuels (Art. 7(2))
Manufacturer’s
choice
EC conformity declaration with type (Annex IV).
NB carries out spot checks on appliances
MODULE Cbis2
EC conformity declaration with type
(production quality assurance, Annex IV)
NB assesses and monitors
manufacturer’s quality system
MODULE D
EC conformity declaration with type
(product quality assurance, Annex IV)
NB assesses and monitors
manufacturer’s quality system
MODULE E
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100
11. Flow chart for the conformity assessment procedures provided for in
Directive 93/15/EEC on explosives for civil uses
MANUFACTURER Manufacturer’s
choice
EC type examination
(Annex II.1)
MODULE B
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 G
Conformity to type (Annex II.2)
NB carries out products checks
at random intervals.
MODULE Cbis2
Production quality assurance
(Annex II.3)
NB assesses and monitors the manufacturer’s
quality system
MODULE D
Production quality assurance
(Annex II.4)
NB assesses and monitors the manufacturer’s
quality system
MODULE E
Product verification (Annex II. 5)
NB verifies and certifies that products
conform with the type
MODULE F
Manufacturer’s
choice
❝ Annex 8 ❞
101
12.1. Flow chart for the conformity assessment procedures provided for in
Directive 93/42/EEC on medical devices
MANUFACTURER
Product
class II B
Product
class II B
Product
class I
EC declaration of
conformity
(Annex VII)
+ technical file
MODULE A
No
Yes
Type of
product
EC type-examination
(Annex III)
MODULE B
Manufacturer’s
choice
Manufacturer’s
choice
Product
class II
Products
in Annex
VII.5
Manufacturer’s
choice
Full quality assurance system (Annex II)
NB assesses and monitors the
manufacturer’s quality system
EC design verification by NB
(Annex II.4) not applicable
MODULE H
Manufacturer’s
choice
EC declaration of
conformity
(Annex VII)
+ technical file
MODULE A
EC verification (Annex IV)
NB verifies and certifies that
products conform with the technical file
MODULE F
Production quality assurance (Annex V)
NB assesses and monitors the manufacturer’s quality
system. Manufacturer declares that products conform
with the technical file
MODULE D
Production quality assurance (Annex VI)
NB assesses and monitors the manufacturer’s quality
system. Manufacturer declares that products conform
with the technical file
MODULE E
EC verification (Annex IV)
NB verifies and certifies that
products conform with the type
MODULE F
Production quality assurance (Annex V)
NB assesses and monitors the
manufacturer’s quality system
MODULE D
Product quality assurance (Annex VI)
NB assesses and monitors the
manufacturer’s quality system
MODULE E
(*)
(*)
(*)
(*) Third party assessment relates to
(a) obtention of sterile devices,
(b) metrological aspects. to Chart 2
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
102
12.2. Flow chart for the conformity assessment procedures provided for in
Directive 93/42/EEC on medical devices (cont.)
EC verification (Annex IV)
NB verifies and certifies that
products conform with the technical file
MODULE F
Production Quality Assurance (Annex V)
NB assesses and monitors the manufacturer’s quality
system. Manufacturer declares that products conform
with the type
MODULE D
Full quality assurance system (Annex II)
NB assesses and monitors the manufacturer’s quality
system. NB verifies and certifies the design
conformity
MODULE E
EC verification (Annex IV)
NB verifies and certifies that
products conform with the type
MODULE F
Production quality assurance (Annex V)
NB assesses and monitors the
manufacturer’s quality system
MODULE D
Product quality assurance (Annex VI)
NB assesses and monitors the
manufacturer’s quality system
MODULE E
No
complementary
CE marking
No CE
marking
Manufacturer’s
choice
Manufacturer’s
choice
EC type-examination
(Annex III)
MODULE B
from Chart 1
Product
class III
Statement concerning devices
for special purposes (Annex VIII)
The manufacturer declares that
products conform with essential
requirements
Devices for clinical
investigations and
custom-made devices
Medical devices, bearing
the CE marking,
marketed as systems
or procedure packs (Art. 12)
Manufacturer declaration
according to Art. 12.2
Sterile
devices
Manufacturer’s
choice
❝ Annex 8 ❞
103
(*) 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.
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
MANUFACTURER
(1)
Manufacturer’s
choice
(*) (**)
Type
of
product
Products
Art. 8.1 (a)
and Art. 8.2
Products
Art. 8. 1(b)
Products
Art. 8.1 (b)(i)
Products
Art. 8.1 (b)(ii)
Products
Art. 8.1 (c)
EC type examination
(Annex III)
MODULE B
Unit verification (Annex IX)
NB verifies and certifies that products
meet the directive requirements
MODULE G
Production quality assurance (Annex IV)
NB assesses and monitors the
manufacturer’s quality system
MODULE D
Manufacturer’s
choice Product verification (Annex V)
NB verifies and certifies that products
conform with the type
MODULE F
Conformity to type (Annex VI)
Manufacturer declares that products
conform with the type
MODULE Cbis1
Production quality assurance (Annex VII)
NB assesses and monitors the
manufacturer’s quality system
MODULE E
Internal control of production (Annex VII)
Manufacturer declares
conformity to the directive and
communicates the technical
file to NB
MODULE A+
Internal control of production (Annex VIII)
Manufacturer declares conformity to the
directive and keeps the technical file
MODULE A
Manufacturer’s
choice
(1) No CE marking
for components
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
104
14. Flow chart for the conformity assessment procedures provided for in
Directive 94/25/EC on recreational craft
MANUFACTURER
Boat design
categories A and B
Hull
length
hull < 12 m
12 m < hull < 24 m
Type of
product
Components
in Annex II
Boat design
category C
Hull
length
2.5 m < hull < 12 m
2.5 m < hull < 12 m
Manufacturer’s
choice
EC type-examination
(Annex VII)
MODULE B
Internal production control
plus test (Annex VI)
MODULE Aa
Comply
with
standards
Manufacturer’s
choice
Boat design
category D
2.5 m < hull < 24 m
Conformity to type (Annex VIII)
Manufacturer declares that
products conform with the type
MODULE C
Production quality assurance
(Annex IX)
NB assesses and monitors the
manufacturer’s quality system
MODULE D
Product verification (Annex X)
NB verifies and certifies that
products conform with the type
MODULE F
Full quality assurance (Annex XII)
NB assesses and monitors the
manufacturer’s quality system
MODULE H
Unit verification (Annex XI)
NB verifies and certifies that
the products meet the directive
requirements
MODULE G
Internal production control
plus tests (Annex VI)
MODULE H
Internal production control
(Annex V)
MODULE A
NO
YES
(1)
(1) Partly completed
boats are not CE
marketed. All products
must be accompanied
by the EC declaration
of conformity.
❝ Annex 8 ❞
105
15. Flow chart for the conformity assessment procedures provided for in
Directive 95/16/EC on lifts
INSTALLER (for lifts)
MANUFACTURER
(for safety components)
Safety
components
on lift
Safety
components
Manufacturer’s
choice
EC type-examination
(Annex V)
MODULE B
Manufacturer’s
choice
Lifts
Installer’s
choice
Design
approach
Lift designed in accordance with
a lift having undergone
EC type-examination (Annex V)
Lift designed in accordance with
a model lift having undergone
EC type-examination
(Annex V)
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
Installer’s
choice
Final inspection (Annex VI)
NB verifies and certifies that lifts meet
Directive requirements
Installer draws up a declaration of conformity
Product quality assurance (Annex XII)
NB assesses and monitors the installer’s
quality system
Installer draws up a declaration of conformity
MODULE E
Production quality assurance (Annex XIV)
NB assesses and monitors the installer’s
quality system
Installer draws up a declaration of conformity
MODULE D
Unit verification (Annex X)
NB verifies and certifies that lifts meet the Directive requirements
Installer draws up a declaration of conformity
MODULE G
Full quality assurance (Annex X)
NB assesses and monitors the installer’s quality system
Installer draws up a declaration of conformity
NB inspects the design where it is not entirely in accordance with
harmonised standards
MODULE Hbis
Conformity to type with random checking (Annex XI)
NB carries out product checks at random intervals
Manufacturer draws up a declaration of conformity
MODULE Cbis2
Product quality assurance (Annex VIII)
NB assesses and monitors manufacturer’s quality system
Manufacturer draws up a declaration of conformity
MODULE E
Full quality assurance (Annex IX).
NB assesses and monitors manufacturer’s quality system
Manufacturer draws up a declaration of conformity
MODULE H
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
106
16. Flow chart for the conformity assessment procedures provided for in
Directive 96/57/EC on refrigeration appliances
MANUFACTURER
Electric mains-operated refrigerators,
frozen food storage cabinets,
food freezers, combination of these
Internal control of production (Annex II)
MODULE A
❝ Annex 8 ❞
107
SEP See Article 3.3 No
(Sound engineering
practice)
17. Directive 97/23/EC concerning pressure equipment
Assemblies
‘Global procedure’
(Art. 10.2)
Safety accessories
(Annex II, point 2)
In general:
Category IV
For specific equipment:
Category of equipment to be protected
CE marking (5)
(a) Each item making up the
assembly:
according to its category;
(b) Integration of items:
according to the highest category of
equipment not considering safety
accessories;
(c) Protection of assembly:
highest category of equipment to be
protected.
Type of equipment Vessels Fired or Piping
Pressure accessories (1) otherwise Pressure accessories (2)
heated
equipment
Fluid to be contained gaseous liquid Steam or gaseous liquid
(Art. 9) d ( ) n-d ( ) d n-d superheated d n-d d n-d
water
Annex II:
Tables 1 2 3 4 5 6 7 8 9
specific categories as a
function of PS, V or DN
Category Applicable procedures CE marking
(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)
I A; A1; D1; E1; B1+D; B1+F; B+E; B+C1; H; B+D; B+F; G; H1 Yes
II A1; D1; E1; B1+D; B1+F; B+E; B+C1; H; B+D; B+F; G; H1
III B1+D; B1+F; B+E; B+C1; H; B+D; B+F; G; H1
IV B+D; B+F; G; H1
(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.
3 4
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
108
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.
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
MANUFACTURER
Manufacturer’s
choice
EC type-examination.
NB examines documentation
and tests products
MODULE B
Manufacturer’s
choice
EC conformity declaration with type
(Annex II)
NB carries out product checks
MODULE Cbis2
EC conformity declaration with type
(production quality assurance)
(Annex II)
NB assesses and monitors
manufacturer’s quality system
MODULE D
EC conformity declaration
(full quality assurance)
(Annex IV)
NB assesses and monitors the
manufacturer’s quality system
MODULE H
❝ Annex 8 ❞
109
MANUFACTURER
Manufacturer’s
choice
Device covered
by Annex II
Referred to in
list B of
Annex II
Intended for
performance
evaluation
Referred to in
List A of
Annex II
Manufacturer’s
choice
Procedure
according to
Annex VIII
Statement
drawn up by
the manufacturer
EC declaration of conformity/
full quality assurance + design
examination + verification of
manufactured products
(Annex IV)
MODULE Hbis +
EC declaration of
conformity/full quality
assurance (Annex IV,
except points 4 and 6)
MODULE H
Yes
Manufacturer’s
choice
EC verification
(Annex V)
MODULE F
EC declaration of
conformity/production
quality assurance
(Annex IV,
except point 5)
MODULE D
EC declaration of conformity/
production quality assurance/
verification of manufactured
products (Annex IV)
MODULE D +
EC type-examination
(Annex V)
MODULE B
EC type-examination
(Annex V)
MODULE B
19.1. Flow chart for the conformity assessment procedures provided for in
Directive 98/79/EC on in vitro diagnostic medical devices
to Chart 2
from Chart 2
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
110
EC declaration of conformity +
examination of design
(Annex III)
MODULE A +
No Intended for
self testing
Manufacturer’s
choice
Yes
No
EC declaration of conformity
(Annex III, except point 6)
MODULE A
Intended for
performance
evaluation
Procedure according to
Annex VIII
Statement drawn up by
the manufacturer
19.2. Flow chart for the conformity assessment procedures provided for in
Directive 98/79/EC on in vitro diagnostic medical devices (cont.)
from Chart 1
to Chart 1
❝ Annex 8 ❞
111
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)
20. Flow chart for the conformity assessment procedures provided for in
Directive 99/5/EC on radio and telecommunications terminal equipment
MANUFACTURER
Manufacturer’s
choice
Other than receiving parts of radio
equipment
Internal control of production,
specific apparatus tests and
examination of the technical
construction file (Annex IV)
MODULE Aa +
Telecommunications terminal equipment
which does not make use of the spectrum
allocated to terrestrial/space radio
communication, receiving parts of radio
equipment
Manufacturer’s
choice
Application of
harmonised standards
No
Yes
Manufacturer’s
choice
Internal control of production
(Annex II)
MODULE A
Full quality assurance
(Annex II)
MODULE H
Internal control of production and
specific apparatus tests
(Annex III)
MODULE Aa
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
112
21. Flow chart for the conformity assessment procedures provided for in
Directive 96/98/EC on marine equipment
Manufacturer’s
choice
Produced individually or
in small quantities and
not in series or in mass
No
Yes
Manufacturer’s
choice
Full quality assurance
and design examination
(Annex B)
MODULE Hbis
Unit verification
(Annex B)
MODULE G
Manufacturer’s
choice
Conformity to type
(Annex B)
MODULE C
Production quality
assurance (Annex B)
MODULE D
Product quality
assurance (Annex B)
MODULE E
Product verification
(Annex B)
MODULE F
MANUFACTURER
EC type-examination
(Annex B)
MODULE B


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
L-2985 Luxembourg
OFFICE FOR OFFICIAL PUBLICATIONS
EUR OF THE EUROPEAN COMMUNITIES