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: Witold.Bialy@polsl.pl
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 przepi-sy dyrektyw odnoszących się do różnych sektorów, ze szczególnym uwzględnieniem obowiązków producen-tów 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 za-kres odpowiedzialności, a także obowiązki producenta związane z oznakowaniem CE. Poruszone zostały tak-że zagadnienia dotyczące dokumentacji technicznej, oceny ryzyka, udziału jednostek notyfikowanych, dekla-racji zgodności. Przedstawiono również podstawowe działania (tzw. kroki), jakie musi wykonać producent, aby umieścić na swoim wyrobie znak CE.
Introduction
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
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 impor-tant factor of enterprises’ increased competitive-ness. 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
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.
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 termi-nology 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 diffe-rences 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 sepa-rate directives (e.g. machine directive 98/37/EU).
The New Approach Directives are legal require-ments 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.
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 regu-lations 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 accep-ted to be used consistently.
Having met all the conformity evaluation re-quirements 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).
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 mark-ings 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.
Technical regulations referred to in the New Approach concern the protection of public goods such as:
health, safety,
environmental protection,
protection of commercial transactions.
Technical provisions contain general specifica-tions applying to products, processes and services, the manner of their production, operating parame-ters etc. All goods which are lawfully present on the EU market must meet the regulation require-ments – administrative sanctions are imposed if the above regulations are not observed.
The requirements specify principal safety ele-ments 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 solu-tion proposed in a harmonized standard or any other technical solution. The application of stan-dards, 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 par-ticular 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 ensur-ing a product’s conformity with the principal requirements of a particular directive. These stan-dards were developed by European harmonization organizations upon the order of the European
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 de-velopment of detailed technical specifications to national harmonization organizations. This philoso-phy allows the current level of technology deve-lopment to be maintained and promotes develop-ment 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 Euro-pean 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 harmo-nized standards ISO/IEC 1700 and EN 45000 series as well as recommendations contained in the Coun-cil’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 evalua-tion modules he has selected (Table 1).
Notified bodies perform tasks specified in con-formity 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
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 ob-tained 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 noti-fied, 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 mem-ber 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].
Table 1. Basic modules Tabela 1. Podstawowe moduły
Module Scope of module
A Internal control of production
Covers internal control of design and production (manufacturing). This module does not require participation of a third party – notified body.
B EC type examination
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. C
Conformity to type
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.
D Production
Quality Assurance1
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 sys-tem within the scope of production, final product control and testing.
E Product Quality Assurance1
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.
F Product Verification
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.
G Final Verification
Covers the design and production stages.
Every single product is examined by a notified body, which issues a conformity certificate.
H Unit Verification1
Covers the design and production stage – quality system in the phase of design, production, final control and product testing.
ISO 9001 standard is applied as a harmonized standard to be met by the system.
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.
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
Polish legal acts implementing the directives 73/23/EEC, 93/68EEC
Low voltage electrical equipment (LVD)
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). 87/404/EEC, 90/488/EEC
93/68/EEC Simple pressure vessels
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). 88/378/EEC, 93/68/EEC
Toys safety (TOYS) The Order by the Minister of Economy, Labour and Social Policy dated 14
th November 2003
relating to basic requirements to be met by toys (the Journal of Laws No. 210, item 2045). 89/106/EEC, 93/68/EEC
Construction products (CPD) The Order by the Minister of Economy, Labour and Social Policy dated 16
th April 2004 relating
to construction products (the Journal of Laws No.92, item 881) and the ordinance issued on its basis. 89/336/EEC, 92/31/EEC
93/68/EEC Electromagnetic compatibility (EMC)
The Order by the Minister of Infrastructure dated 2nd April 2003 relating to the evaluation of
equip-ment conformity with basic requireequip-ments 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). 89/686/EEC, 93/95/EEC,
03/68/EEC, 96/58/EC Personal protection
quipment (PPE)
The Order by the Minister of Economy, Labour and Social Policy dated 31st March 2003 relating
to basic requirements for individual protection means (the Journal of Laws No. 80, item 725). 90/384/EEC
Non-automatic weighing instruments
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).
90/42/EEC, 93/68/EEC Gaseous fuel burning
appliances
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).
92/42/EC, 93/68/EEC Efficiency of water heating
boilers fired with liquid or gaseous fuels
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).
93/15/EEC Explosive materials
for civil use
The act relating to explosive materials for civil use dated 21st June 2001 (the Journal of Laws
No. 117, item 1007 and No. 238, item 2019). 94/9/EEC
Protection equipment and systems to be used in
explosive atmospheres
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).
94/25/EC
Recreational craft 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). 94/62/EEC
Packaging and packaging waste
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). 95/16/EEC
Lifting equipment (lifts)
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).
96/48/EEC Interoperability of the
trans-European high-speed rail system
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).
96/57/EEC Energy efficiency for house-hold refrigerators and freezers
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).
96/98/EEC Maritime equipment
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
equip-ment requireequip-ments (the Journal of Laws No. 103, item 1091). 97/23/EEC
Pressure equipment
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).
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 Ap-proach (supplemented with the Global ApAp-proach) as an appropriate and effective regulatory module enabling the application of technological innova-tions and increasing the European market’s compe-tiveness 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 Commis-sion 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 har-monization 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 evalu-ate 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.
cont. Table 2. cd. Tabela 2.
Directives directive number first version and subsequent
changes Polish legal acts implementing the directives 98/37/EEC
Machine safety (MD)
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).
99/5/EC Telecommunications ter-minal equipment (RTTE)
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
con-formity 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). 2000/9 EC
Cableway devices designed to carry persons
The Order by the Minister of Infrastructure dated 11th December 2003 relating to basic requirements
to be fulfilled by cableway installations designed to carry persons (the Journal of Laws No. 15, item 130).
2000/14/EC Noise emission in the
envi-ronment by equipment for outdoor use
The Order of the Minister of Economy, Labour and Social Policy dated 2nd July 2003 relating to basic
requirements to be fulfilled by outdoor equipment within the scope of noise emission in the environ-ment (the Journal of Laws No. 138, item 1316).
2001/16/EC Interoperability of the trans- -European conventional rail
system
The rail transport act dated 28th March 2003 (the Journal of Laws No. 86, item 789, No. 170, item
1652 and No. 203, item 1966 and 2004, No. 92, item 883, No. 96, item 959 and No. 97, item 962).
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
93/42/EEC Medical products
98/79/EEC Medical products for in vitro
diagnostics
The Medical Products Act dated 27th July 2001 (the Journal of Laws 1380 with amendment in the
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 pro-ducer 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
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 do-cumentation 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 re-quirements 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 coun-tries (so-called third councoun-tries).
The new approach directives also require a pro-ducer 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
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 product is subject to any of the directives that require the CE marking or several types of mark-ing at the same time.
Become acquainted with the texts of directives which may potentially apply to a given product. The definition of products subject to the directive as well as the list of exceptions, if applicable, should be thoroughly analysed.
A producer has to find out which of the basic requirements contained in a relevant directive apply to a particular product.
Carry out an analysis of threats posed by the product. Make a list of basic requirements to be met by a given product, the fulfilment of which will allow the 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.
A producer has to prepare technical documentation which contains elements required by a relevant directive.
Technical documentation must be prepared by the producer so that it may be submitted to the market supervision bodies upon request. If a producer has its seat in a so-called third state (outside EEA) and has not yet appointed his autho-rized representative, then technical documentation must be kept by the importer. A producer has to complete the conformity
evalu-ation procedure prescribed in the directive for a particular product.
In case of some products an external unit (notified body) has to participate and issue a relevant certificate.
In most cases an independent evaluation of a product by its producer is suffi-cient.
A producer has to issue a conformity declaration.
A conformity declaration is always issued by the producer (authorized repre-sentative) 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 has to place the CE mark on a product. A producer (or his authorized representative) places the CE mark on a product on his own in order to demonstrate that all the requirements and procedures have been fulfilled.
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 so-called notified body) takes part, issuing a relevant certificate(s). However, this does not change the principle that the mark is always placed on a pro-duct by its producer on his own.
Table 3 presents a simplified procedure of “sub-sequent 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 re-quirements 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 packag-ing or accompanypackag-ing 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.
Summary
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 relat-ing to the organization of the market supervision in a member state. More detailed provisions are con-tained in the directive relating to general safety of products. These provisions are a reference point for the market supervision exercised within the frame-work of the New Approach directives, especially in the area of consumer goods. A responsible authori-ty may not be a notified body, the activiauthori-ty 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 natio-nal 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.
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 manufac-tured in line with relevant EU requirements and may equip it with the CE mark. In this case the producer (or his authorized representative, impor-ter) must also take into consideration the require-ments 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 dy-rektyw nowego i globalnego podejścia”. Warszawa 2008. 2. HUTYRA A.: Oznakowanie CE. Europejski symbol
bezpie-czeństwa wyrobów. Stowarzyszenie Wolna Przedsiębior-czość, Oddział terenowy w Gdańsku, Warszawa 2003. 3. Rezolucja Rady ws. Globalnego podejścia do oceny
zgod-ności (Dz. Urz. WE C 010, 16.01.1990, s. 1), Decyzja Ra-dy 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 zgod-ności.
4. http://ec.europa.eu/enterprise/newapproach/nando. 5. Oznakowanie CE. Urząd Ochrony Konkurencji i
Konsu-mentów, Warszawa 2004.
Recenzent: dr hab. inż. Ruta Leśmian-Kordas, prof. AM Akademia Morska w Szczecinie
