CE Marking
Conformité Européene (CE) means 'Compliance with European Norms'. The CE conformity marking is a sign indicating that the product or product group on which it is attached satisfies the minimum requirements required for health, safety, environment and consumer protection in accordance with the "New Approach Directives". The CE marking is not a quality marking nor is it an approval of the quality of the product. It indicates that the product was produced and controlled in accordance with all the conditions determined in the relevant directives.
The CE marking ensures the free movement of the product in the European Union market, such as a product passport, and unmarked products cannot enter the European Union countries.
According to the New Product Liability Law, if any accident happens due to the related product or any of the EU countries asserts that the product does not conform to the requirements of CE marking, namely, the product is not safe enough, the producer has to demonstrate that it has taken all the measures. The CE marking activities carried out erroneously or deficiently may cause great damages to producers. Producer is responsible for the product it produces.
HISTORICAL DEVELOPMENT OF CE MARKING
The European Union countries have endeavored to create an internal market since the Treaty of Rome signed in 1946. In the single to be created, it will be ensured that goods, services, people and capital move freely. The free movement of goods has been prevented for many years because of the freedom of the member states of the European Union to regulate their own national safety and health conditions. Different technical product regulations and testing procedures have given rise to creation of trade barriers among the member states of the European Union, which has conflicted with the objective of a single market. All in all, the European Commission and Board has aimed at removing the trade barriers by harmonizing the national legislations of the member states by being inspired by many decisions of the Court of Justice of the European Union. The procedures of the CE Conformity Marking being one of the outcomes of such a harmonization are carried as follows:
• The legislations in force of the countries being valid for consumption and industrial products will be harmonized with each other. Thus, the creation of a single market is encouraged,
• The costs of producers are reduced,
• The safety of the products is enhanced,
• The product is controlled by authorized bodies.
In this case, the CE Conformity Marking will provide benefit to producers.
PRODUCTS REQUIRING TO BEAR CE MARKING (NEW APPROACH DIRECTIVES)
• A producer is, in the sense of New Approach, a person being responsible for the design and production of a product with a view to placing such product on the community market on its own behalf.
• Producer is liable to ensure the design and production of the product planned to be placed on the community market and evaluation of such product’s conformity to the fundamental requirements of the related new approach directives applied.
• Producer may use ready products, ready parts or components or procure its works to be carried out by a sub-contractor. However, the general control should be at all times with the producer that should have the necessary competency in order to assume responsibility relating to the product.
Producer is a real or legal person being responsible for the design and production of a product with a view to placing such product on the Community market under its own name. The responsibilities of the producer will apply also to real or legal persons assembling, packing, processing the product or labeling the ready-made products with a view to placing such product on the Community market under its own name. Besides, the responsibility of producer may apply also to persons creating a product changing the product in such a way that different fundamental requirements will be caused to be needed or which may be deemed to be a new product.
Producer may design and produce the product on its own. Alternatively, producer may procure the design, production, assembly, packaging, processing and labeling to be made by others for the product to be placed on the Community market under its own name and introduce itself as the producer. Where a subcontractor is assigned, the producer should retain its control over the product and be able to provide the necessary information in order for it to fulfill its responsibilities within the scope of the New Approach Directives. By delivering some or all of its operations to a sub-contractor, a producer cannot eliminate its responsibilities; for instance, a producer cannot assign its responsibilities to an authorized agent, distributor, wholesaler, retailer, user or a sub-contractor.
Producer is the sole and ultimate responsible person for the product’s conformity to be evaluated to the related directives applied irrespective of the fact that it itself designs and produces the product or it is regarded as producer due to the fact that the product is placed on the market under its own name.
PRODUCER;
Producer is responsible for designing and producing the product in compliance with the basic requirements determined in the related directive or directives and realization of the evaluation of conformity of the product in compliance with the procedures determined in the related directive or directives.
Producer is liable to have the design and production knowledge that may enable it to assume the responsibility of the product being in harmony with all the provisions of the related New Approach Directives. This applies equally to the situations where the producer designs, produces, packages and labels the product on its own and the situations where it procures some or all of such operations to be carried out by a sub-contractor.
As for evaluation of compliance, the responsibility of producer depends on the procedure applied. As a general rule, the producer should take all the necessary measures in order to ensure that the production process ensures the conformity of the product, CE marking is attached to the product, the technical dossier is prepared and the EC Declaration of Conformity is issued. Depending on the directive, it may be necessary for the producer to send the product to a third party (generally to a notified body) for testing and certification thereof or to have its own quality system certified by a notified body. Furthermore, certain directives introduce complementary provisions (such as the requirement that explanatory information accompanies the product)
Directives require generally that the producer is introduced on the product; for instance, by being specified on a sign on the product or on a document accompanying the product. However, sometimes it is not possible to determine who is responsible for the design and production of the product in reality. Unless otherwise provided for, this situation does not reduce the responsibility of the person (e.g. a real or legal person importing a new or used product from a third country) placing the product on the Community market. Accordingly, the person placing the product on the Community market is required to ensure the conformity of the product to the relating directives and realization of the suitable conformity evaluation procedures.
A product (e.g. products produced by the producer for its own use) may be offered for service before being placed on the market. In such a case, it is considered that the person offering the product for service gas assumed the responsibilities of the producer. Accordingly, the person offering the product for service is required to ensure that the product is in compliance with the provisions of the directive and suitable conformity evaluation procedures are realized.
New approach directives do not require the presence of a producer within the Community. Therefore, the responsibilities of a producer arising from the directives are the same irrespective of the fact that the producer is present outside the Community or within a Member State.
PRODUCT LIABILITY
Any product produced within the Community or imported, which causes damage to people and properties, falls within the scope of the product liability directive. Therefore, this directive applies also to the products which fall within the scope of the New Approach directives.
Product liability directive introduces a stringent liability regime for both producers and importers within the Community.
Product liability directive comprises also all the movable properties and electricity along with the components and raw materials of an end product. Services are excluded for the time being. Secondly, the directive applies to defective products that do not satisfy the safety requirements as will be expected normally by a person only. For use intended by a product, the fact that it is not compliant is not sufficient. If a product is deprived of safety, the Directives will apply. Production of a better product afterwards does not cause previous models to be considered to be faulty.
The liability to indemnify the damages lies with the producer. Producer is a person introducing itself (for instance, by placing a trademark) as either the manufacturer of a finished product or a component thereof or producer of any raw material or producer. Importers bringing the products from third countries to the Community market are regarded at all times as producers according to the Product Liability Directive. If the producer cannot be determined, and in case any kind of supplier of the product does not inform the injured party of the identity of the product or the party providing it with the product within a reasonable period of time, it will become responsible. In case where more than one person is responsible for the same damage, all of them will be responsible jointly and individually.
The producer should indemnify the damages caused by the defective product to persons (death, injury) and in terms of private ownership thereof (goods for private use). However, the Directive does not include any damage below 500 ECU in its scope in terms of a single case. The intangible damages (e.g. suffering) may be regulated by national legislation. The Directive does not comprise the situation where the defective product destroys itself and therefore there is not any liability to indemnify with respect to this in the Product Liability Directive save for the provisions of the national law.
The producer is not responsible for the damages caused by the product automatically. The injured party should make a claim of indemnity irrespective of the fact that it is the person purchasing or using the defective product. Payment is made to the sufferer only when it proves that it has incurred damages, the product is defective and the damage has been caused by such product. If the injured party contributes to this damage, the liability of the producer may diminish or even be declined. However, since the Product Liability Directive uses the strict liability of the producer as a base, the sufferer is not required to prove that the producer has acted negligently. Thus, even if any act or negligence of a third party has contributed to the damages incurred, the standards have been applied or the product has been tested, it has proven that it did not act negligently, the producer will not be relieved of the liability.
If the producer proves the following, it will be relieved of paying indemnity:
• That it has not placed the product on the market (e.g. the fact that the product has been stolen;
• That the product was not defective when it was placed on the market (thus, it proves that the damage has come into existence afterwards)
• That the product was not produced for the purpose of being sold
• That the defect was arisen from compliance with the obligatory regulations published by the public organizations (this situation excludes the national and European standards and international standards)
• That the scientific and technical know-how situation of the product at the moment at which it has been placed on the market is not at the degree to suffice to understand the defect (defense of risks arising from development)
• That, in case the producer is a sub-contractor, the defect has arisen either from the design of a finished product or the erroneous instructions given by the producer of the product to it)
• The liability of the producer expires ten years after the placement of the product on the market unless there is any lawsuit not adjudged yet or any ongoing lawsuit. Besides, the sufferer is required to take an official step within three years from determination by the sufferer of the damage, negligence and the producer. No agreement can be made on removal of the obligation relating to the injured party.
• The Product Liability Directive does not require the member states to repeal the other legislations regarding responsibility. In this context, the regime in the directive is included in the previously existing national rules relating to the responsibility. The option on which bases the lawsuit will be brought lies with the sufferer.
The Product Groups which fall within the scope of the New Approach Directives
Every directive defines the products which fall within its own scope. This annex is not an exhaustive list of the products which fall within the scope of such directives and it has not been taken into consideration that certain directives exclude certain products although such products are in compliance with the description of the product in the directive.
Title of the Directive, the Definition of Scope in general
1) Low voltage equipment, electrical equipment designed for being used between 50-1000 volt for alternative current and 75-1500 volt for direct current for being used in varying voltages between 75-1500 volt.
2) Simple pressure vessels, vessels manufactured serially for being used for containing air or nitrogen gas used for the purpose of combustion and with internal pressure higher than 0.5 bar.
3) Toys, products or materials designed for being used in games of children younger than 14 years of age.
4) Construction Materials, materials produced for the purpose of being used permanently in all works including the construction and other civil engineering works.
5) Electromagnetic Compatibility: All electrical and electronic devices used together with the equipment or installations containing electrical and/or electronic components that may cause electromagnetic incompatibility or the performance of which may be affected by such an incompatibility.
6) Machineries: The tools consisting of various parts and groups, at least one part of which moves by means of a suitable actuator, control and power circuits, serving to process, handle or package a material, named as machineries; assembly of machineries regulated and controlled in order to operate as a whole for the purpose of ensuring the purpose attained when used alone; any replaceable equipment mounted by user to a machine or various machinery group or a tractor and changing the function of a machine on condition that they are not spare parts or tools.
7) Personal Protective Equipment: Tools and equipment designed for the purpose of being protected against one or more health and safety risks, being put on, worn or borne by persons;
A whole consisting of many tools or equipment brought by manufacturer into a whole with a view to protecting the person against one or more risks at the same time;
Detachable or non-detachable protective tools or equipment used together with an equipment bone or worn without the purpose of protection for an activity to be carried out;
Parts that are necessary for operation of Personal Protective Equipment functionally and being able to be used together with such kinds of equipment only;
8) Non-automatic weighing instruments: Weighing instruments serving to determine the magnitudes, quantities, parameters or characteristics of the mass of an object benefitting from the force of gravity impacting on such object or magnitudes relating to other mass and for which intervention of a user is needed during the process of weighing operations;
9) Implantable Active Medical Devices: The equipment, tools, devices, materials or other materials designed for being used for humans for certain purposes (diagnosis of an illness, keeping it under control, monitoring, treatment of the same, etc.), being able to be used alone or in conjunction with other devices and systems (including the accessories or computer software necessary for the intended function to be able to be fulfilled), being able to be operated with an external source of energy, the whole or one part thereof being able to be placed into human body, a natural body inlet or cavity by means of a medical or surgical intervention and necessary to remain in the area where they are;
10) Devices burning Gas: The devices or forced blow burners named as devices burning gas, used for the purpose of cooking, heating, obtaining hot water, cooling, lighting or washing and, if required used for the purpose of obtaining water the temperature of which does not exceed 105°C, running by fuel of gas and the heating elements equipped with such burners;
Safety, control and adjustment equipment other than the forced blow burners and the heating elements equipped with such burners, marketed on their own with commercial purposes, designed for being installed to devices burning gas or, when assembled, forming such a device and their partial assemblies;
11) Hot Water Boilers: A unit combined with the burner running with liquid or gas with nominal output power between 4 kW - 400 kW and designed for transferring the heat coming into existence as a result of combustion;
A body of the boiler designed for mounting a burner or a burner designed for being mounted to the boiler, named as device.
12) Explosives for Civil Uses: The materials and substances regarded as explosives in the Recommendations of United Nations in transportation of dangerous goods and which fall within the class number 1 of such recommendations;
13) Medical Devices: Any and all kinds of devices, tools, instruments, materials or other materials named as devices which are manufactured by the manufacturer for certain purposes such as diagnosis, keeping under control, monitoring and treatment of an illness, and which do not fulfill their primary function when used on human beings by means of pharmacological, immunological or metabolic impacts;
Any part or parts manufactured for the purpose of being used in conjunction with and in harmony with devices, although not deemed to be medical device on their own;
14) Equipment used in Potentially Explosive Environments: The machineries, devices, fixed or portable tools, control components designed for being used in potentially explosive environments (the tools necessary for safe operation of an equipment and protective system that does not have autonomous (individual) function) and the diagnosis and protection systems used in potentially explosive environments (explosive environments that may come into existence due to local or functional conditions) and separately or in conjunction with other environments, used for processing raw material and designed for generation, transfer, storage, measurement, control and transformation of the energy that may give rise to explosion with its own ignition potential;
The design units named as protective systems, created for being used in potentially explosive environments, serving to stop the newly starting explosives immediately and/or limit the impact of the flames of the explosion and explosion pressure and offered to the market on their own as stand-alone systems;
The Safety Tools, Control Devices and Regulators necessary for the safety of an equipment or protective system designed for being used outside of potentially explosive environments; however, being related to explosion risk or contributing such safety;
15) Touristic Boats: Boats with exact length between 2.5m and 24m, which has been measured according to the suitable harmonized standard, and designed for sportive and touristic purposes;
Partly Designed Boats consisting of Body and/or one or more components;
Components referred to in Annex II, and being detached or mounted to a boat;
16) Elevators: The system named as elevator, giving service at certain levels in apartments and constructions, not being flexible and having a cabinet moving along rails forming an angle no more than 15o to the horizontal plane, through which persons and goods, or, in case it has a cabinet into which a person may enter without difficulty and has a control easily accessible, only goods are intended to be transported;
The safety components referred to in Annex No. IV of the Directive and used in elevator;
17) Freezers: Electric refrigerators,
Frozen food storage cabinets,
Food freezers, and their combinations;
18) The reservoirs named as pressure vessels* designed and manufactured in order to contain the fluids under pressure including the supplements coming up to the connection point of other equipment;
Pipe named as pipe fittings* designed to carry the liquids when connected with each other for integration within a pressure system;
The devices named as safety accessories* for protection against the permissible limits for pressure equipment;
The devices named as pressure accessories having functional operation and having compartments carrying pressure;
The various parts of pressure equipment named as assemblies (equipment)* assembled by manufacturer for forming an integrated and functional whole;
*On condition that maximum allowable PS pressure is greater than 0.5 bar.
19) Telecommunication Terminal Equipment: Equipment designed for the purpose of transmitting wireless signals only or receiving wireless signals only and both receiving and transmitting wireless signals by means of satellites or other systems located in space, as well as used for transmitting, processing or receiving such signals by being connected to national telecommunication network;
20) The reagent, reagent product, calibrator, control material, kit, tools, equipment or system designed for being used for humans for certain purposes (diagnosis of an illness, keeping it under control, monitoring, treatment or alleviation of the same, etc.), being able to be used alone or in conjunction with other devices and systems (including the accessories or computer software necessary for the intended function to be able to be fulfilled), not fulfilling their primary function when used on human beings by means of pharmacological, immunological or metabolic impacts, designed for examination of samples received from human body for in vitro medical device operations irrespective of being used alone or in conjunction with other devices;
Accessories particularly designed for being used in conjunction with the above in in-vitro diagnosis procedures.
21) Wireless and Telecommunication Terminal Equipment: Equipment or the respective part thereof named as telecommunication terminal equipment and ensuring the communication or designed for being connected directly or indirectly to the interfaces of national telecommunication networks;
The device or the respective part thereof ensuring communication by means of transmission and/or receipt of wireless waves spread out from the space.
Audit and Certification of CE Marking
The EU supervises whether the CE marking is attached in accordance with the laws and rules. The member states are required to form “market supervision organizations” serving to this purpose. It is not possible for the notified bodies to render service also as a market supervision organization (in order to preclude probable conflicts of interest).
A similar supervision operation is carried out also for products of third country origin. The market supervision in imported goods requires greatly the involvement of customs officials.
Customs officials may seize the goods and prevent their distribution in case they determine that:
the products have characteristics that may create serious and sudden risk on health and safety;
the documents and signs of the products relating to product safety are deficient; and
In this case, there are non-conformities relating to procedure and essence with respect to the use of CE marking as with in-EU trade. In case of existence of a situation contrary to procedure, the market supervision organizations are advised and instruction is expected from them and, in case there is not any hazardous situation posed during that period, the distribution of the product is not prevented. In case there is a situation contrary to the essence, the notification and seizure may take place concurrently. In case of determination afterwards, the product is recalled from the market and the injured party is indemnified.