CE marks - Scientific Journals of the Maritime University of Szczecin

Scientific Journals
Zeszyty Naukowe
Maritime University of Szczecin
Akademia Morska w Szczecinie
2010, 23(95) pp. 15–23
2010, 23(95) s. 15–23
CE marks – passport for the product to the EU markets
Oznakowanie CE paszportem dla wyrobu na rynek UE
Witold Biały
Silesian University of Technology, Faculty of Organisation and Management
Institute of Production Engineering
Politechnika Śląska w Gliwicach, Wydział Organizacji i Zarządzania, Instytut Inżynierii Produkcji
41-800 Zabrze, ul. Roosevelta 26, e-mail: [email protected]
Key words: conformity assessment, directives, legal acts, notified body
Abstract
The aim of this publication is presenting the rules of new, global approach towards EU market. There were
presented the regulations of directives related to various sectors, emphasizing the obligations of
manufacturers operating on the European market. There were explained the basic rules which must be obeyed
by the manufacturers in order to introduce their products in the EU member states. The technical
requirements of the products and the scope of responsibility were indicated. Also the obligations related to
CE marking were presented. There were also mentioned the aspects related to technical documentation, risk
assessment, participation of notified bodies and declaration of conformity. There were also presented the
basic actions (steps) which must be undertaken by the manufacturer in order to introduce the product to the
EU market.
Słowa kluczowe: ocena zgodności, dyrektywy, akty prawne, jednostka notyfikowana
Abstrakt
Celem artykułu jest przedstawienie zasad nowego, globalnego podejścia do rynku UE. Przedstawiono przepisy dyrektyw odnoszących się do różnych sektorów, ze szczególnym uwzględnieniem obowiązków producentów działających na rynku UE. Omówiono podstawowe zasady które powinien przestrzegać producent, aby
wprowadzić swój wyrób do obrotu w państwach UE. Wskazano na wymagania techniczne wyrobów oraz zakres odpowiedzialności, a także obowiązki producenta związane z oznakowaniem CE. Poruszone zostały także zagadnienia dotyczące dokumentacji technicznej, oceny ryzyka, udziału jednostek notyfikowanych, deklaracji zgodności. Przedstawiono również podstawowe działania (tzw. kroki), jakie musi wykonać producent,
aby umieścić na swoim wyrobie znak CE.
Introduction
which are signatories to the agreement on creating
the European Economic Area – EEA.
A free flow of commodities (no barriers) is
a foundation of the EU market – it is a very important factor of enterprises’ increased competitiveness. A basic principle on the EU market is the one
saying that only safe products may be placed on the
market and rendered for use on the EU territory [1].
The EU regulations in force ensure a free flow of
commodities as well as a high level of consumer
and user protection.
The Court of Justice of the European Union in
a famous case “Cassis de Dijon” as of 20th February
Since Poland acceded to the European Union
(01.05.2004) industrial goods sold in Poland and
abroad have had to comply with the EU safety
standards. Entrepreneurs who want to sell their
commodities must evaluate their compliance with
the New Approach Directives (NAD) of the
European Union. A producer (importer) is obliged
to ensure that his goods will not create any threat to
the health and safety of users. This obligation
applies to all EU member states as well as Iceland,
Norway and the Duchy of Lichtenstein – the states
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Witold Biały
1979 (Measures having an equivalent effect for
quantitative limitations) defined a very important
principle of mutual recognition. Pursuant to this
ruling, a national legislation of a country being
a European Union member should comply with this
rule.
The principle of mutual recognition [1] says
that: A product lawfully marketed in one Member
State should be allowed to be marketed in any other
Member State. The Member State of destination
may refuse to market a product in its current form
only where it can demonstrate that this is strictly
necessary for the protection of e.g. public safety,
health and environment. In that case, the Member
State of destination must also demonstrate that its
measure is the least trade-restriction measure.
A Directive is a legal act of the European Union
addressed to all member states which imposes
an obligation on the member states to issue within
a specified period of time their own national regulations implementing the requirements contained
in the directive.
The provisions of the New Approach directives
must be fully reflected in national regulations.
On the other hand, member states are free to choose
a form in which the directives will be introduced
on the territory of a particular country (e.g. a law,
order or another legal act).
The directives provide a possibility of benefiting
from the so-called transition period, after which the
regulations contained in the directive come in force.
In legal acts which implement particular New
Approach directives, the “CE marking” was accepted to be used consistently.
Having met all the conformity evaluation requirements and procedures that apply to a product,
a producer places the CE marking on it. The CE
marking has a strictly defined form (Fig. 1).
CE marking (Conformite Europeenne –
European Conformity)
This expression originates from the history of
the New Approach directives and diversified
expressions in original texts. Until 1993 the “CE
mark” was applied in New Approach Directives.
The graphic form of the mark was individually
defined in particular directives, or was not defined
at all. The 93/465/EEC decision introduced a new
unified graphic form of this marking and explicitly
defined its role.
A change in the “CE mark” formulation into
“CE marking” was initiated by the European
Parliament. The reason which influenced the terminology change was introducing a differentiation
between many already existing certification marks
and the European symbol of compliance with the
New Approach directives, i.e. CE marking. This
change was accepted as in many cases the differences between certification marks and CE marking
were still misunderstood.
Such differentiation applies to e.g. “B” mark
(safety mark), which is a mark of obligatory
certification – relevant changes were introduced in
all New Approach existing directives.
When Poland acceded to the UE structures,
it was obligated to prepare accurate translations
of texts contained in the full set of EU legal acts,
so-called acquis, which include both the original
versions of directives and the directives amending
the same. The changed texts, so-called unified texts
are not in force unless they are published as separate directives (e.g. machine directive 98/37/EU).
The New Approach Directives are legal requirements contained in more than 20 EU directives.
Each of them applies to a different category of
goods, although one product may be subject to
a few directives at the same time.
Fig. 1. CE mark
Rys. 1. Znak CE
If, for any reasons, the CE marking must be
enlarged or reduced in size, it must be properly
proportioned – a minimum height of the marking
may not be less than 5 mm [2].
In their regulations the EEA countries should
not introduce any references to conformity markings other than the CE marking, as this would be
contrary to the CE marking tasks.
A product may have additional markings and
marks if they:
 serve another purpose than the CE marking,
 will not be confused with the CE marking,
 will not limit the legibility and visibility of the
CE marking.
New approach directives
The “New Approach” is a technical legislation
(technical harmonization directives) the content of
which has been limited to principal requirements.
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CE marks – passport for the product to the EU markets
Technical regulations referred to in the New
Approach concern the protection of public goods
such as:




Commission on the basis of principal requirements
of a given directive. Hence, the application of these
standards provides a basis for presumption of
a product’s conformity with the basic requirements
contained in a particular directive.
The New Approach is a law which establishes
merely basic safety requirements, leaving the development of detailed technical specifications to
national harmonization organizations. This philosophy allows the current level of technology development to be maintained and promotes development of new technologies in particular member
states of the European Union.
As the New Approach required that reliable
procedures of conformity evaluation be applied, its
philosophy was supplemented with basic principles
of the EU conformity policy, called a global
approach. This enabled introducing a consistent
approach to conformity evaluation procedures
owing to the use of so-called modules, including
the stage of design and manufacturing.
The global approach specifies guidelines
concerning the application of conformity evaluation
in technical harmonization directives and defines
the following principles [3]:
 placing and using the CE marking along with its
graphic form,
 application of quality assurance standards (EN
45000 series – which is currently being replaced
with EN 17000 series),
 promotion and application of the accreditation
system.
Table 1 contains a list of eight basic conformity
evaluation modules. The list of modules given in
table 1 does not apply to the construction products
directive (CPD).
Notified bodies were established by the European Committee in order to complete tasks included
in conformity evaluation procedures. The European
Commission grants an identification number to
them. The requirements to be met by a notified
body are contained in relevant directive and harmonized standards ISO/IEC 1700 and EN 45000 series
as well as recommendations contained in the Council’s decision 93/465/EEC. The producer has to
include a notified body in the process of conformity
evaluation, if this is required by conformity evaluation modules he has selected (Table 1).
Notified bodies perform tasks specified in conformity evaluation procedures in a situation when
a third party opinion is required. Notified bodies
should act in a competent, non-discriminating,
comprehensible, neutral, independent and impartial
way. They also have to take part or be represented
health,
safety,
environmental protection,
protection of commercial transactions.
Technical provisions contain general specifications applying to products, processes and services,
the manner of their production, operating parameters etc. All goods which are lawfully present on
the EU market must meet the regulation requirements – administrative sanctions are imposed if the
above regulations are not observed.
The requirements specify principal safety elements which are necessary to protect the public
interest. These are usually general requirements
referring to:






designing,
manufacturing,
research,
marking,
instructions,
materials.
The above presented requirements are obligatory
and have to be met before any products are
launched or rendered for use on the EU market.
Basic requirements for products are specified in law
regulations, while the manner of fulfilling these
requirements is given in harmonized standards,
which are detailed technical specifications for these
products.
When designing and manufacturing a product,
a manufacturer may choose for his product a solution proposed in a harmonized standard or any
other technical solution. The application of standards, including harmonized ones, is voluntary.
An exception are construction products, in case
of which harmonized standards are the only ones
which must be applied in order to comply with the
directive and be allowed to use the CE marking.
The New Approach Directives are related to particular harmonized standards. The scope (number)
of harmonized standards related to a particular
directive may differ – ranging from one to more
than a thousand (LVD low voltage directive).
The application of and reference to harmonized
standards is the easiest and simplest way of ensuring a product’s conformity with the principal
requirements of a particular directive. These standards were developed by European harmonization
organizations upon the order of the European
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Witold Biały
Table 1. Basic modules
Tabela 1. Podstawowe moduły
Module
A
Internal
control of
production
B
EC type
examination
C
Conformity
to type
D
Production
Quality
Assurance1
E
Product
Quality
Assurance1
F
Product
Verification
G
Final
Verification
Scope of module
Covers internal control of design and production (manufacturing). This module does not require participation of a third
party – notified body.
Covers the design stage and must be supplemented with a production stage evaluation module (C, D, E, F). After the
examinations are completed with a positive result, a notified body issues an EC type examination certificate.
Covers the production stage and supplements module B. It includes assurance of conformity with the type described in
EC type examination certificate, issued within the framework of module B. In module C, participation of a notified
body is dependent on the provisions of applicable directives.
Covers the production stage and supplements module B.
ISO 9001 standard is applied as a harmonized standard to be fulfilled by a quality system.
Module D provides for participation of a certified body which approves and supervises a manufacturer’s quality system within the scope of production, final product control and testing.
Covers the production process and supplements module B.
ISO 9001 standard is applied as a harmonized standard to be met by a quality system.
Module E provides for participation of a certified body which approves and supervises a manufacturer’s quality system
within the scope of production, final product control and testing.
Covers the production stage and supplements module B.
A notified body verifies conformity with the type specified in the EC type examination certificate issued within the
framework of module B, and issues a conformity certificate.
Covers the design and production stages.
Every single product is examined by a notified body, which issues a conformity certificate.
Covers the design and production stage – quality system in the phase of design, production, final control and product
testing.
H
Unit
ISO 9001 standard is applied as a harmonized standard to be met by the system.
Verification1 Module H entails participation of a notified body, which approves and supervises a manufacturer’s system within the
scope of design, production, final product control and product testing.
1
All modules employing a quality system refer to relevant standards, i.e. ISO 9000 series standards.
in the process of establishing European standards or
ensure a regular access to up-dated information on
relevant standards.
Notified bodies are and should be independent
from their clients and other interested parties – they
have to ensure confidentiality of information obtained in the process of conformity evaluation.
A notified body may offer its services related to
conformity evaluation within the scope of their
notification to any economic subject both on the
territory of the European Union and outside it. It is
a service provided to producers on a public interest
basis.
Producers may choose any of the notified bodies
which has been appointed to carry out a particular
conformity procedure in line with the provisions of
a relevant directive.
The European Commission publishes a list of
notified bodies in the EU Official Journal – this list
is up-dated on a regular basis and available on the
European Commission’s website [4]. To be notified, it must have the status of a legal person in one
of the EU member states, therefore it must be
subject to the jurisdiction of this country. The EU
member states assume responsibility towards other
member states and the Union institution for notified
bodies’ competences. For this reason, the EU member states are obliged to check the competences of
units applying for notification.
The competences of a notified body should be
supervised and controlled on a regular basis.
Notification is withdrawn only when a notified
body no longer fulfils the requirements or fails to
perform its duties in a proper way. Withdrawal of
notification is the responsibility of a member state
which notified a given body.
Currently there are 21 directives which have
been adopted according to the New Approach
principles requiring the CE marking, 4 directives
based on the New Approach principles in which
this marking is not required and 5 directives based
on the principles of the New Approach and Global
Approach – one of them requires a symbol marking
(“pi” letter), and the remaining ones – the CE
marking.
The directives which require the CE marking as
well as legal acts implementing the same are given
in table 2 [5].
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CE marks – passport for the product to the EU markets
Table 2. Directives implementing the CE marking and Polish legal acts
Tabela 2. Dyrektywy wprowadzające oznakowanie CE oraz polskie akty prawne
Directives directive number
first version and subsequent
changes
73/23/EEC, 93/68EEC
Low voltage electrical
equipment (LVD)
87/404/EEC, 90/488/EEC
93/68/EEC
Simple pressure vessels
88/378/EEC, 93/68/EEC
Toys safety (TOYS)
89/106/EEC, 93/68/EEC
Construction products (CPD)
89/336/EEC, 92/31/EEC
93/68/EEC
Electromagnetic
compatibility (EMC)
89/686/EEC, 93/95/EEC,
03/68/EEC, 96/58/EC
Personal protection
quipment (PPE)
90/384/EEC
Non-automatic weighing
instruments
90/42/EEC, 93/68/EEC
Gaseous fuel burning
appliances
92/42/EC, 93/68/EEC
Efficiency of water heating
boilers fired with liquid or
gaseous fuels
93/15/EEC
Explosive materials
for civil use
94/9/EEC
Protection equipment
and systems to be used in
explosive atmospheres
94/25/EC
Recreational craft
94/62/EEC
Packaging and packaging
waste
95/16/EEC
Lifting equipment (lifts)
96/48/EEC
Interoperability of the transEuropean high-speed rail
system
96/57/EEC
Energy efficiency for household refrigerators and freezers
96/98/EEC
Maritime equipment
97/23/EEC
Pressure equipment
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Polish legal acts implementing the directives
The Order by the Minister of Economy, Labour and Social Policy dated 12th March 2003 relating
to basic requirements to be met by electrical equipment (the Journal of Laws No. 49, item 414).
The Order by the Minister of Economy, Labour and Social Policy dated 12th May 2003 relating
to basic requirements to be met by simple pressure vessels (the Journal of Laws No. 98, item 898).
The Order by the Minister of Economy, Labour and Social Policy dated 14th November 2003
relating to basic requirements to be met by toys (the Journal of Laws No. 210, item 2045).
The Order by the Minister of Economy, Labour and Social Policy dated 16th April 2004 relating
to construction products (the Journal of Laws No.92, item 881) and the ordinance issued on its basis.
The Order by the Minister of Infrastructure dated 2nd April 2003 relating to the evaluation of equipment conformity with basic requirements within the scope of electromagnetic compatibility and its
marking (the Journal of Laws No. 90, item 848) and the telecommunications law act dated 16th July
2004 (the Journal of Laws No. 171, item 1800).
The Order by the Minister of Economy, Labour and Social Policy dated 31 st March 2003 relating
to basic requirements for individual protection means (the Journal of Laws No. 80, item 725).
The Order by the Minister of Economy, Labour and Social Policy dated 11th December 2003
relating to basic requirements to be met by non-automatic weighing instruments subject to
conformity evaluation (the Journal of Laws No. 4, item 23).
The Order by the Minister of Economy, Labour and Social Policy dated 15th April 2003 relating
to basic requirements to be met by gaseous fuel burning appliances (the Journal of Laws No. 91,
item 859).
The Order by the Minister of Economy, Labour and Social Policy dated 12th May 2003 relating
to basic requirements within the scope of energy efficiency of new water heating boilers fired with
liquid or gaseous fuels (the Journal of Laws No. 97, item 881).
The act relating to explosive materials for civil use dated 21 st June 2001 (the Journal of Laws
No. 117, item 1007 and No. 238, item 2019).
The Order by the Minister of Economy, Labour and Social Policy dated 28th July 2003 relating
to basic requirements to be met by protection equipment and systems used in areas endangered
with explosion (the Journal of Laws No. 143, item 1393).
The Order by the Minister of Economy, Labour and Social Policy dated 31 st March 2003 relating
to basic requirements to be met by recreational craft (the Journal of Laws No. 91, item 857).
The act dated 11th May 2001 relating to packaging and packaging waste (the Journal of Laws
No. 63, item 638 as of 2003, No. 7, item 78 and 2004, No. 11, item 97 and No. 96, item 959).
The Order by the Minister of Economy, Labour and Social Policy dated 22nd May 2003 relating
to basic requirements to be met by lifts and their safety elements (the Journal of Laws No. 11, item
1107).
The act dated 28th 2003 relating to rail transport (the Journal of Laws No. 86, item 789, No. 170,
item 1652 and No. 203, item 1966 and as of 2004, No. 92, item 883, No. 96, item 959 and No. 97,
item 962).
The Order by the Minister of Economy, Labour and Social Policy dated 2nd December 2003 relating
to basic requirements within the scope of electrical energy consumption by refrigerating equipment
(the Journal of Laws No. 219, item 2157).
The act dated 20th April 2004 relating to maritime equipment (the Journal of Laws No. 93, item
899). The Order by the Minister of Infrastructure dated 30th April 2004 relating to maritime equipment requirements (the Journal of Laws No. 103, item 1091).
The Order by the Minister of Economy, Labour and Social Policy dated 10th April 2003 relating to
basic requirements to be met by pressure equipment and pressure equipment assemblies (the Journal
of Laws No. 99, item 912).
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Witold Biały
cont. Table 2.
cd. Tabela 2.
Directives directive number
first version and subsequent
changes
98/37/EEC
Machine safety (MD)
99/5/EC
Telecommunications terminal equipment (RTTE)
Polish legal acts implementing the directives
The Order by the Minister of Economy, Labour and Social Policy dated 10th April 2003 relating to
basic requirements to be met by machines and safety elements (the Journal of Laws No. 91, item
858).
The Telecommunications Law Act dated 16th July 2004 (the Journal of Laws No. 171, item 1800).
The Order by the Minister of Infrastructure dated 15th April 2004 relating to the evaluation of conformity of terminal telecommunications equipment to be connected to public network and radio
equipment with basic requirements as well as their marking (the Journal of Laws No. 73, item 659).
The Order by the Minister of Infrastructure dated 11th December 2003 relating to basic requirements
2000/9 EC
Cableway devices designed to be fulfilled by cableway installations designed to carry persons (the Journal of Laws No. 15, item
to carry persons
130).
2000/14/EC
Noise emission in the environment by equipment for
outdoor use
The Order of the Minister of Economy, Labour and Social Policy dated 2 nd July 2003 relating to basic
requirements to be fulfilled by outdoor equipment within the scope of noise emission in the environment (the Journal of Laws No. 138, item 1316).
2001/16/EC
Interoperability of the trans- The rail transport act dated 28th March 2003 (the Journal of Laws No. 86, item 789, No. 170, item
-European conventional rail 1652 and No. 203, item 1966 and 2004, No. 92, item 883, No. 96, item 959 and No. 97, item 962).
system
89/106/EEC, 93/68/EEC
Construction products
The Building Law Act dated 7th July 1994 (the Journal of Laws No. 89, item 414, with changes, in
particular with an amendment published in the Journal of Laws as of 2001, No. 129, item 1439) and
executive orders.
90/385/EEC, 93/42/EEC,
93/68/EEC
Active medical implants
The Medical Products Act dated 27th July 2001 (the Journal of Laws 1380 with amendment in the
93/42/EEC
Medical products
Journal of Laws No. 152 as of 2002, item 1264) and executive orders.
98/79/EEC
Medical products for in vitro
diagnostics
An analysis of the situation on the EU common
market shows that on the one hand, the Council has
confirmed (the Council’s resolution on the global
approach to conformity evaluation as of January
1990, replaced by the decision dated March 1993
relating to the modules of different conformity
evaluation stages) the importance of the New Approach (supplemented with the Global Approach)
as an appropriate and effective regulatory module
enabling the application of technological innovations and increasing the European market’s competiveness of the European, while on the other hand, it
has confirmed a necessity to extend the scope of
applying this approach in new areas.
On 14th February 2007 the European Commission proposed a new package of activities (the New
Approach revision), known as “A package for
products on the internal market”. The package,
constituting a legal framework, includes definitions
known from the so-called Blue Guide, containing
directives for the implementation of technical harmonization directives – at present these are not
directives, but harmonized regulations that all
member states are obliged to observe. The New
Approach directives apply to products which are to
be marketed or rendered for use for the first time,
i.e. products that are new on the EU market, as well
as new products and second-hand imported goods
from outside the European Union (so-called third
countries).
We have two kinds of the CE mark, the shape
and location of which on a product are precisely
determined. Most frequently we come across letters
alone, but we may also buy a product which has
a four-digit number next to the CE marking. This is
the identification number of a notified body and
means that this body remains responsible for the
activities specified in a particular directive (Fig. 2).
Of course, first the notification body had to evaluate the product’s conformity with this directive
according to the procedure contained in it. The
identification number is placed by the producer or
his authorized representative within the EEA
territory.
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CE marks – passport for the product to the EU markets
representative of the producer and the scope of
authorization covers the CE mark placing. If an
importer decides to do so, then in the understanding
of the conformity system act, he stops being an
importer and becomes a producer, which entitles
him to place the CE mark on a product as its
manufacturer.
A producer is obliged to prepare technical documentation which certifies a product’s conformity
with basic requirements of relevant directives.
Technical documentation must contain the data and
evidence of product’s conformity with basic requirements of relevant directives. Documentation
has to be drawn up by the producer, as he is the
only one who thoroughly knows the product from
the design/construction phase to its production and
use. This obligation applies to all producers, not
only from the EEA states, but also from other countries (so-called third countries).
The new approach directives also require a producer to identify threats (analyses) and evaluate the
level of risk involved in the use of a product.
Basing on the risk evaluation results, a producer
chooses appropriate steps (ordered at the stage of
product design) aimed at reducing the threats to
Fig. 2. CE mark with the number of notified body
Rys. 2. Znak CE z numerem jednostki notyfikowanej
The procedure of placing the CE marking
on a product
The obligation and right to place the CE mark
on the produced goods rests solely and exclusively
with the manufacturer (if a product is subject to the
obligation of being equipped with this mark).
A manufacturer is understood as a person who
designs and manufactures a product on his own, as
well as a person who has a product designed and
produced by another party to next market or render
it for use in his own name, using his own brand
name or trademark. This is the case when a producer has a seat in a so-called third country, i.e.
outside EEA. A producer may order his authorized
representative to place the CE mark on a product,
provided that the latter has a registered seat in one
of the EEA states.
An importer has no right to place the CE mark
on a product, unless he is also an authorized
Table 3. Subsequent steps leading to the CE mark placement on a product
Tabela 3. Kolejne kroki prowadzące do umieszczenia znaku CE na wyrobie
Description of task
Steps to be taken
A producer must decide on his own whether his
Become acquainted with the texts of directives which may potentially apply to
product is subject to any of the directives that
a given product. The definition of products subject to the directive as well as the
require the CE marking or several types of marklist of exceptions, if applicable, should be thoroughly analysed.
ing at the same time.
A producer has to find out which of the basic Carry out an analysis of threats posed by the product. Make a list of basic
requirements contained in a relevant directive requirements to be met by a given product, the fulfilment of which will allow the
apply to a particular product.
threat to be eliminated or reduced.
A producer should identify European harmonized
standards applicable to a particular product and
design the product according to these standards
(or apply a solution other than that specified in
harmonized standards).
The application of harmonized standards creates a presumption of conformity
with basic requirements, therefore these standards should be applied.
If a producer does not follow these standards (he has a right to do so), he ought
to apply other specifications and demonstrate their conformity with basic
requirements.
Technical documentation must be prepared by the producer so that it may be
A producer has to prepare technical documentation
submitted to the market supervision bodies upon request. If a producer has its
which contains elements required by a relevant
seat in a so-called third state (outside EEA) and has not yet appointed his authodirective.
rized representative, then technical documentation must be kept by the importer.
In case of some products an external unit (notified body) has to participate and
A producer has to complete the conformity evalu- issue a relevant certificate.
ation procedure prescribed in the directive for
In most cases an independent evaluation of a product by its producer is suffia particular product.
cient.
A producer has to issue a conformity declaration.
A conformity declaration is always issued by the producer (authorized representative) irrespective of any certificates previously obtained from notified
bodies. A conformity declaration is not required for toys. In case of certain
products (e.g. machines) a conformity declaration must be enclosed with the
product – most frequently it is stored together with technical documentation.
A producer (or his authorized representative) places the CE mark on a product
A producer has to place the CE mark on a product. on his own in order to demonstrate that all the requirements and procedures have
been fulfilled.
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21
Witold Biały
Summary
an acceptable level. Risk evaluation is a key part of
the procedure applied by a producer in order to
ensure that using the product does not entail an
unacceptable level of threat to the health and safety
of persons, pets or property. If a producer does not
use harmonized standards, he must make sure that
the solutions he has chosen fulfil the basic
requirements of relevant directives – this must
clearly result from technical documentation.
The CE mark is not “obtained” from or
“granted” by any external unit. This mark is always
placed by the manufacturer of a product or his
authorized representative. In case of the so-called
conformity procedure, which precedes the placing
of the CE mark on a product, an external unit (a socalled notified body) takes part, issuing a relevant
certificate(s). However, this does not change the
principle that the mark is always placed on a product by its producer on his own.
Table 3 presents a simplified procedure of “subsequent steps” leading to the CE mark placement
on a product.
The CE marking is the only marking which
symbolizes conformity with all the obligations
imposed on manufacturers of particular products,
proving the product’s conformity with relevant
directives providing for the CE mark placement.
The use of the CE marking is free of charge as
a producer is obliged to take into account the requirements of directives which apply to his product.
A producer places the CE mark on a product only
when it has met all the requirements of applicable
directives (Table 3).
In their regulations the EEA states should not
make any references to other markings than the CE
mark which are contrary to the tasks of the CE
marking.
The CE mark should be placed on a product or
its rating plate. As an exception, in the event this
principle may not be applied, the CE mark should
be placed in any other location, e.g. on the packaging or accompanying documents.
This is justified in the following cases:
 marking of a product is impossible (e.g. some
types of explosives),
 marking of a product is impossible in reasonable
technical or economic cases,
 there is no possibility of maintaining minimal
dimensions.
Neglecting and failing to place the CE mark due
to aesthetic reasons is not allowed. The CE mark
placed on a product has to be unerasable so that it
cannot be removed under normal conditions of the
product’s use.
The provisions of the New Approach directives
oblige the EEA member states to make sure that
the products placed on the market and rendered for
use do not endanger human health or safety and do
not create a risk to other interests referred to in
a relevant directive (if these products have been
properly constructed, installed and used for what
they were intended). Irrespective of the country of
origin of a product placed on the EEA market, the
citizens of these countries have a right to expect
that it meets relevant requirements related to the
level of protection. This imposes on the member
states an obligation to supervise the market in order
to prevent launching of products which do not fulfil
the directives’ requirements, and if possible, detect
and remove such products from the market. An
efficient system of market supervision is not only
the interest of consumers, employees, users or
buyers, but also entrepreneurs, as it contributes to
eliminating the unfair competition.
The EEA member states are obliged to appoint
or establish authorities responsible for the market
supervision. The structure of supervision may be
different in each member state (each state takes
independent decisions on the manner of supervision
organization). Except for fragmentary provisions
contained in the toy directive, the New Approach
directives do not contain detailed guidelines relating to the organization of the market supervision in
a member state. More detailed provisions are contained in the directive relating to general safety of
products. These provisions are a reference point for
the market supervision exercised within the framework of the New Approach directives, especially in
the area of consumer goods. A responsible authority may not be a notified body, the activity of which
is indirectly the subject of control exerted as part of
the market supervision.
The market supervision consists of two stages:
national authorities responsible for the market
supervision have to monitor the conformity of
products placed on the market with relevant national law regulations which correspond to the New
Approach directives (Table 3), and in consequence,
take appropriate steps to ensure conformity.
Despite the fact that the market supervision
intervention should not take place at the stage
of product design and production, the effectiveness
of activities undertaken by the market supervision
bodies requires their cooperation with producers
and suppliers of goods in order to prevent non-conforming products from being placed on the
market.
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CE marks – passport for the product to the EU markets
The market supervision authorities should also
check if the CE mark has been properly placed and
applied, as well as whether the regulations relating
to additional markings and signs are observed.
The CE mark may not be placed on products for
which it is not required. The market supervision
authorities should take appropriate preventive
measures within this scope.
In the event a product is intended also for the
market of countries outside EEA, the manufacturer
has a right to declare that the product was manufactured in line with relevant EU requirements and
may equip it with the CE mark. In this case the
producer (or his authorized representative, importer) must also take into consideration the requirements of the market for which this product is
intended.
Major statements referring to the CE marking:
• the CE marking means a product’s conformity
with relevant EU regulations,
• the CE marking is placed on a product by its
manufacturer when all basic requirements – all
applicable New Approach directives have been
fulfilled,
• a producer does not need permission to use the
CE marking,
• the graphic form of the CE mark is precisely
defined – it should be minimum 5 mm high,
• the CE marking must be placed on a product in
a permanent and visible way which cannot be
removed,
• the CE marking applies to all new products
(as well as products classified as new) included
in the regulations of minimum one New
Approach directive,
• the CE marking is considered a “passport” for
goods on the EEA internal market.
References
1. Oznakowanie CE dla wyrobów. Projekt Bliźniaczy
PL2005/IB/EC-01. Publikacja sfinansowana przez Unię
Europejską w ramach Projektu Transition Facility 2005 nr
PL2005/017-488.02.02 „Wsparcie MSP we wdrażaniu dyrektyw nowego i globalnego podejścia”. Warszawa 2008.
2. HUTYRA A.: Oznakowanie CE. Europejski symbol bezpieczeństwa wyrobów. Stowarzyszenie Wolna Przedsiębiorczość, Oddział terenowy w Gdańsku, Warszawa 2003.
3. Rezolucja Rady ws. Globalnego podejścia do oceny zgodności (Dz. Urz. WE C 010, 16.01.1990, s. 1), Decyzja Rady 90/683/EWG (Dz. Urz. WE L380, 31.12.1990, s. 13),
zastąpiona Decyzją 93/465/EWG (Dz. Urz. WE L220,
30.08.1993, s. 23) ws. modułów różnych faz oceny zgodności.
4. http://ec.europa.eu/enterprise/newapproach/nando.
5. Oznakowanie CE. Urząd Ochrony Konkurencji i Konsumentów, Warszawa 2004.
Recenzent:
dr hab. inż. Ruta Leśmian-Kordas, prof. AM
Akademia Morska w Szczecinie
Zeszyty Naukowe 23(95)
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