CE Marking

What is CE Marking (CE Mark)?

CE Marking is the symbol of letters "CE" which are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents. "CE Mark" is also in use, but it is NOT the official term.

1. CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.*

*Product Directives contains the "essential requirements" and/or "performance levels" and "Harmonized Standards" to which the products must conform. Harmonized Standards are the technical specifications (European Standards or Harmonization Documents) which are established by several European standards agencies (CEN, CENELEC, etc).

CEN stands for European Committee for Standardization.
CENELEC stands for European Committee for Electrotechnical Standardization.

2. CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country.
3. CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries), and
4. CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities.

Along with more directives' becoming effective, more and more products are required to bear the CE Marking for gaining access to the EFTA & European Union market. However, many non-EU exporters are still unaware of or unsure about this fact and its impact on their business.

Please click the following links to learn more about every CE-Marking-related European Union Directive, Guidelines to Directives, Frameworks of implementation of Directives, and Agreements on Mutual Recognition of conformity assessment between European Union and other countries such as USA, Japan, Canada, Australia, New Zealand and Israel:-

Why is CE Marking called-
the "Passport to Europe" for non-EU products?

The European Union's 'New Approach directives' are mandatory on all member countries to enact through national legislation.

This legislation requires manufacturers to display CE Marking on their product, packaging and accompanying literature. Where a new approach directive is in force, it is (with few exceptions) an offence to place a product on the market without CE Marking. The manufacturer is legally responsible for ensuring that the product confirms to the requirements of the directive and for applying CE Marking.

CE Marking is one important measure that the EU has adopted to establish the single market and foster economic development for the member states. The objective of the directives is to simplify the movement of goods into and within the EU. This may eventually lead to the free movement of goods throughout Europe as more and more european countries are expected to join the EU. The European Commission thus refers to the CE Marking as a "Passport" which allows products to be freely circulated within the EU single market.

Often, consumers will consider CE Marking on a product as an indication of conformance to laid down minimum standards, and therefore a minimum level of quality which other products may lack. CE Marking is thus for many consumers a "Symbol of Quality." Being a manufacturer exporting to EU, if you have not got your products fixed with CE Marking, it is now time to invest in it. A CE Marking on your product will be more valuable than millions of dollars spent on TV advertising. Nowadays, it is not unusual to see some high-quality, even known brand, products have to appear in Second-hand Stores (which sells used products) or on street-vendor's Stands. Why? lack CE Marking!

How does CE Marking
affect the export to Europe?

If the new product directives apply to your products and you want to continue to export to the European market (or introduce new products), then CE Marking will be crucial to your success.

It is NOT unusual nowadays that non-EU manufacturers and exporters have had their product(s) seized by customs officials in the European Union at the worst or returned to them because they do not have the CE marking affixed to the product(s).

The CE Marking can be, at the same time, of both benefits and disadvantages.

Benefits:

• With this "passport" your products can easily gain access to the entire European Union (EU) plus European Free Trade Association (EFTA) market.
• There will be only one set of laws and regulations for the entire marketplace which guide the designing, manufacturing and labeling of products. The multiple and conflicting national restrictions on regulated products will be eliminated. Thus the CE Marking on your product will make your trade with EU countries cheaper and easier.
• Your product will be made safer for consumers and thus the damage claims and liability premiums will be reduced.

Disadvantages:

• New product directives may exceed the current national laws and regulations. It may cost a manufacturer extra to modify the currently existed design and/or production line in order to continue exporting to or gain access to this huge European market.
• Extra costs in obtaining the product Certificate of Registration for CE Marking and any, if applicable, required testing certification.

How many countries
are currently requiring products to bear CE Marking?

Total 28 countries.

Before May 1, 2004 these were the 15 European Union (EU) member countries: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxemburg, the Netherlands, Portugal, Spain, Sweden and United Kingdom (Great Britain) plus the European Free Trade Association - EFTA's 3 member states: Iceland, Liechtenstein and Norway.

Since May 1 2004, the following 10 new member states joined the EU, which also adopted the CE-Marking requirements:

Estonia, Latvia, Lithuania, Poland, Czech Republic, Slovakia, Hungary, Slovenia, Malta, and Cyprus.

Please click the following links to learn more about every CE-Marking-related European Union Directive, Guidelines to Directives, Frameworks of implementation of Directives, and Agreements on Mutual Recognition of conformity assessment between European Union and other countries such as USA, Japan, Canada, Australia, New Zealand and Israel:-

How many CE Marking Publications?

Wellkang Consultant can deliver, normally within 24 hours after receiving the payment, totally more than 100 CE Marking-related publications (all in .PDF version), ie. the European Union Product Directives, Guidelines to the Applications of Directives, Framework of Implementation of Directives, Mutual Recognition Agreements between EU and other countries as well as other publications in different languages: English (en), French (fr), German (de), Italian (it), Portuguese (pt), Spanish (es) and Swedish (sv).

Does my product need CE Marking?

CE Marking is most probably required if you export to the 25 European Union (EU) and 3 European Free Trade Association (EFTA) member states the following 22 groups of products -

1. Appliances Burning Gaseous Fuels (AppliGas)
   The "appliances burning gaseous fuels" used for cooking, heating, hot water production, refrigeration, lighting or washing and having, where applicable, a normal water temperature not exceeding 105 gC. Forced draught burners and heating bodies to be equipped with such burners will also be considered as appliances.
   The "gaseous fuel" means any fuel which is in a gaseous state at a temperature of 15 gC under a pressure of 1 bar. more >>
2. Cableway Installations to Carry Persons
   The "cableway installations designed to carry persons" shall mean installations made up of several components, designed, manufactured, assembled and put into service with the object of carrying persons.
   These on-site installations are used for the carriage of persons in vehicles or by towing devices, whereby the suspension and/or traction is provided by cables positioned along the line of travel. . more >>

3. Low Voltage Electrical Equipment
   The "Electrical Equipment" means any equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current (A.C.) and between 75 and 1500 V for direct current (D.C.). Therefore, it is called often "Low Voltage Electrical Equipment" which includes the vast majority of electrical equipment in everyday use. more >>
4. Construction Products
   The "construction product" means any product which is produced for incorporation in a permanent manner in construction works, including both buildings and civil engineering works. more >>
5. Equipment and Protective Systems for Used in Potentially Explosive Atmospheres (Atex)
• Equipment means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy for the processing of material and which are capable of causing an explosion through their own potential sources of ignition.
• Protective systems means design units which are intended to halt incipient explosions immediately and/or to limit the effective range of explosion flames and explosion pressures. Protective systems may be integrated into equipment or separately placed on the market for use as autonomous systems.
• Components means any item essential to the safe functioning of equipment and protective systems but with no autonomous function. Explosive atmospheres Mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture.

Potentially explosive atmosphere means an atmosphere which could become explosive due to local and operational conditions. . more >>

6. Explosives for Civil Uses
   The "Explosives" here shall mean the materials and articles considered to be such in the United Nations recommendations on the transport of dangerous goods and falling within Class 1 of those recommendations. more >>
7. Hot Water Boilers
   The "hot-water boilers" here means a boiler fired by liquid or gaseous fuels with a rated output of between 4 kW and 400 kW (including 4 kW and 400 kW). more >>
8. Household Refrigerators & Freezers
   more >>
9. Lift
   The "lift" here means an appliance serving specific levels, having a car moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal and intended for the transport of:
   - persons,
   - persons and goods,
   - goods alone if the car is accessible, that is to say, a person may enter it without difficulty, and fitted with controls situated inside the car or within reach of a person inside. more >>
10. Machinery
    the "machinery" means:
• an assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material,
• an assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,
• interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool. more >>

11. Marine Equipment
    The "Marine Equipment" here means items listed in Directive 96/98/ec Annexes A.1 and A.2 which must be placed on board a ship for use in order to comply with international instruments or are voluntarily placed on board for use, and for which the approval of the flag State administration is required according to international instruments. more >>
12. Medical Devices
    A "Medical Device" is defined in Directive (93/42/EEC) as: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of :
• diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap.
• investigation, replacement or modification of the anatomy or of a physiological process.
• control of conception

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means. more >>

13. Active Implantable Medical Devices
    The "active medical device" means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity
    The "active implantable medical device" means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure. more >>
14. In Vitro Diagnostic Medical Devices
    The "in vitro diagnostic medical device" means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
    - concerning a physiological or pathological state, or
    - concerning a congenital abnormality, or
    - to determine the safety and compatibility with potential recipients, or
    - to monitor therapeutic measures.. more >>
15. Non-automatic Weighing Instruments
    A "Weighing Instrument" is defined as a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics.
    A "non-automatic weighing instrument" is defined as a weighing instrument requiring the intervention of an operator during weighing. more >>
16. Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
    A "radio equipment" means a product, or relevant component thereof, capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated to terrestrial/space radiocommunication.
    
    A "telecommunications terminal equipment" means a product enabling communication or a relevant component thereof which is intended to be connected directly or indirectly by any means whatsoever to interfaces of public telecommunications networks (that is to say, telecommunications networks used wholly or partly for the provision of publicly available telecommunications services). more >>
17. Personal Protective Equipment (PPE)
    The "personal protective equipment" means any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards. more >>
18. Simple Pressure Vessels
    The "simple pressure vessel" means any welded vessel subjected to an internal gauge pressure greater than 0,5 bar which is intended to contain air or nitrogen and which is not intended to be fired. more >>
19. Pressure Equipment
    The "Pressure Equipment" means vessels, piping, safety accessories and pressure accessories.
    Where applicable, pressure equipment includes elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, lifting lugs, etc.
    'Vessel` means a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment. A vessel may be composed of more than one chamber.
    'Piping` means piping components intended for the transport of fluids, when connected together for integration into a pressure system. Piping includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing components as appropriate. Heat exchangers consisting of pipes for the purpose of cooling or heating air shall be considered as piping.
    'Safety accessories` means devices designed to protect pressure equipment against the allowable limits being exceeded. Such devices include:
    - devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS), and
    - limiting devices, which either activate the means for correction or provide for shutdown or shutdown and lockout, such as pressure switches or temperature switches or fluid level switches and 'safety related measurement control and regulation (SRMCR)` devices.
    'Pressure accessories` means devices with an operational function and having pressure-bearing housings.
    'Assemblies` means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole. more >>
20. Recreational Craft
    The "Recreational craft" means any boat of any type, regardless of the means of propulsion, from 2,5 to 24 m hull length, measured according to the appropriate harmonized standards intended for sports and leisure purposes. more >>
21. Toys
    A "toy" shall mean any product or material designed or clearly intended for use in play by children of less than 14 years of age. more >>
22. Trans-European Conventional Rail System
    The "Trans-European Conventional Rail system" means the structure composed of lines and fixed installations, of the trans-European transport network, built or upgraded for conventional rail transport and combined rail transport, plus the rolling stock designed to travel on that infrastructure. more >>

How to achieve CE mark approval, CE testing and meet all CE mark requirements, for my product?

There are a series of steps outlined below for CE mark approval. Depending upon your product and the nature of the risks it presents:

1. Determine if any directives apply to your product. If more than one applies you will have to comply with all of them.
2. Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).

Choose the conformity assessment procedure from the options (modules) called out by the directive for your product. There are several modules available for the Conformity Assessment Procedures as listed below:

Module A: internal production control
Module Aa: intervention of a Notified Body
Module B: EC type-examination
Module C: conformity to type
Module D: production quality assurance
Module E: product quality assurance
Module F: product verification
Module G: unit verification
Module H: full quality assurance

The directives often use a series of questions about the nature of your product to classify the level of risk and refer to a chart called "Conformity Assessment Procedures". The chart includes all of the acceptable options available to a manufacturer to certify their product and affix the CE Marking.

Minimal Risk

Options for products with minimal risk include self certification where the manufacturer prepares a Declaration of Conformity and affixes the CE Marking to their own product.

Greater Risks

Many directives require products/systems with greater risks to be independently certified; this must be done by a "Notified Body". This is an organization that has been nominated by a Member Government and has been notified by the European Commission. Notified bodies serve as independent test labs and perform the steps called out by directives. They must have the necessary qualifications to meet the testing requirements set forth in the directives. Notified bodies may be a private sector organization or a government agency. Manufacturers may choose a notified body in any member state of the European Union. Lists of notified bodies are published by the European Commission in the Official Journal of the European Communities.

A Notified Body is usually able to offer some of the services required:

• product testing
• type examination certificate issue
• Technical File and design dossier evaluation
• surveillance of product and quality system
• identification of standards

If your products need to be certified by a Notified Body, then you will need to do as the follows:

1. Select the applicable product standards and test methods for your product and select a Notified Body.
   
   
2. Establish an Authorized Representative in the European Union for your product.
   
   Some directives require that a manufacturer designate in the European Union an authorized representative to produce Technical Documentation (or sometimes called Technical File) in a timely fashion when called upon to do so. The CE Marking itself is not meant to provide details about the product to Surveillance Authorities.

Technical Documentation (Technical File): The directives require for many products that a Technical Documentation (Technical File) be prepared by the manufacturer. The Technical Documentation (Technical File) holds information that verifies that the testing was conducted properly and that the product complies with applicable standards.

3. Prepare a Declaration of Conformity.
   The Declaration of Conformity must contain information adequate for tracing the product back to the manufacturer or the authorized representative in the European Union. It may include a list the directives and standards that your product conforms to, product identification, the manufacturer's name, address and signature.
4. Register your product in EU
   Many products, for instance, Class I Medical Devices, are required to be registered in the EU and, if proved, get a Certificate of Registration. Without this Certificate of Registration, the products are NOT allowed to be affixed with the CE Marking and be placed on the market.
5. Affix the CE Marking to your product.
   There are specific rules to adhere to for the CE Marking. These rules address the size and location of the Marking; affixing the CE Marking to products, packaging and material or documents shipped with the product; and specific limitations on when and who is permitted to affix the CE Marking.

Who's going to enforce the requirement for CE Marking?

Each member state of the European Union (EU) is bound by the General Product Safety Directive to adopt laws, regulations and administrative provisions to ensure that products placed on the market are safe. Each country has its own way of handling enforcement.

Many have added staffs specifically to conduct spot checks against implemented directives and respond to complaints. Countries have also set in place a combination of Return-to-Origin procedures, financial penalties, etc.
EU legislations make EU importers liable for the products they import, including the machinery they provide to their employees for work. Many non-EU exporters are finding that no matter how interested a prospective EU importer may be in the product, the importer will NOT risk importing non-conforming products (i.e. the products without CE Marking) which, in case of accident, may generate legal action against them.

Please click the following links to learn more about every CE-Marking-related European Union Directive, Guidelines to Directives, Frameworks of implementation of Directives, and Agreements on Mutual Recognition of conformity assessment between European Union and other countries such as USA, Japan, Canada, Australia, New Zealand and Israel: