CE Marking
The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements. When you buy a new phone, a teddy bear, or a TV within the EEA, you can find the CE mark on them. CE marking also supports fair competition by holding all companies accountable to the same rules.
By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the EEA. This also applies to products made in other countries that are sold in the EEA.
There are two main benefits CE marking brings to businesses and consumers within the EEA:
- Businesses know that products bearing the CE marking can be traded in the EEA without restrictions.
- Consumers enjoy the same level of health, safety, and environmental protection throughout the entire EEA.
What is CE marking?
The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements. When you buy a new phone, a teddy bear, or a TV within the EEA, you can find the CE mark on them. CE marking also supports fair competition by holding all companies accountable to the same rules. By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the EEA. This also applies to products made in other countries that are sold in the EEA.
What products need CE marking?
| 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 | 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 >> |
| 9 | 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 >> |
| 10 | Measuring Instruments the “measuring instrument” means: any device or system with a measurement function that is covered by Articles 1 and 3; more >> |
| 11 | 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 >> |
| 12 | 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 >> |
| 13 | 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 >> |
| 14 | 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 >> |
| 15 | 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 >> |
| 16 | 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 >> |
| 17 | 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 >> |
| 18 | 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 >> |
| 19 | 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 >> |
| 20 | 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 >> |
IMPORTANT NOTE:
Not all products must have CE marking. It is compulsory only for most of the products covered by the New Approach Directives. It is forbidden to affix CE marking to other products.
Please note that a CE marking does not indicate that a product have been approved as safe by the EU or by another authority. It does not indicate the origin of a product either.
When did CE marking came into effect?
The European Single Market was created at the beginning of 1992, with the objective of removing barriers to trade throughout the European Economic Area. In the period up to 1992, and subsequently, the European Parliament has enacted a series of measures intended to put the Single Market into practice. Some of these Directives, the “New Approach Directives”, specify controls on product design and documentation and include the requirement to affix the CE mark. Full details of the creation and implementation dates for each CE marking directive can be found on our Directives pages.
What are the directives?
The CE marking Directives are documents published by the European Commission that lay out the protection requirements (design safety) and the administrative requirements for products intended to be manufactured or imported into the EU. There are many Directives, covering a large range of products, but they all essentially contain these two distinct sets of requirements. However, the directives do not state how the requirements are to be specifically and quantifiably achieved. This task is left to each individual EU member state to implement into their own national laws. This, in turn, is the role of the standards. Various multinational committees meet to produce and update standards relating the safety, marking, design etc of products within their fields. These standards are implemented at national, European or international level and some are ultimately adopted by the member state governments to specify the requirements of the Directives. When a standard has been referenced by the European Commission (by publication in the Official Journal of the EU), it can be adopted by a member state as a yardstick to use for product compliance. In this situation a product which complies with the approved standards for a given Directive can be presumed to comply with the essential requirements of the Directive. For a full list of the CE marking (and some non-CE marking) Directives, see our detailed directives pages.
What is CE logo?
The CE logo is affixed to the product at the end of the CE marking process and is a declaration by the manufacturer/importer that the product meets the essential requirements of any applicable CE marking directives. It has a specific format and must be kept in the correct proportion and have a minimum height of 5mm.
How to get CE mark?
Basically designing a product to meet the relevant standards, creating a Technical File and producing a Declaration of Conformity. What you really need to do is to demonstrate that you have fulfilled the essential requirements of any relevant directives. These are in two parts; Protection requirements and Administrative requirements. The protection requirements relate to the design of the product and can be demonstrated by meeting the requirements of the relevant harmonised standards. The administrative requirements relate to how the product is CE marked. This generally involves the manufacturer producing a Declaration of Conformity and a technical file containing design/manufacturing information and also the application of the CE mark to the product.
CE Terminology
CE mark -This is the manufacturer/importer’s declaration that the product has met the essential requirements of the applicable CE marking directives. It is not a ‘safety’ mark as such and is not actually for the direct benefit of the consumer. Technical File – Whoever placed the CE mark on the product should have the necessary documentation to demonstrate the essential requirements of the applicable directives have been met. This is what the technical file does, so it should contain all design info, test results, assessments, etc. Declaration of Conformity –As well as placing the CE mark on the product and producing a technical file, the manufacturer/importer must also produce and sign a declaration of conformity. This is a single page document ‘summing up’ the CE marking process that has been followed. So it should list who the manufacturer/importer is, what equipment it refers to, which directives have been met and which standards have been used to demonstrate compliance. It also must contain a signatory of the person responsible for the CE marking of the product! Declaration of Incorporation – This is specifically for products under the Machinery Directive that are sold in a non-complete state, to be incorporated into a complete machine. Basically, when the product being sold is part of a larger complete unit, it may not itself have all the required safety features, but will meet the essential safety requirements of the Machinery Directive when finally installed. In these cases, the machine can be issued with a Declaration of Incorporation and a specification for its installation, so the customer knows it meets the requirements as far as it can, and if they install it as per the manufacturers instructions it will meet all the essential requirements. Directives – Legal documents published by the European Commission that lay down requirements for Member State Governments to include in their national laws. Some of them require CE marks, but most do not. They cover a massive range of subjects, but our website is only interested in CE marking and closely related directives. The CE marking directives are rather vague and the legislative structure they set up includes specific provision for standards to be written to contain the working detail. Standards – Documents published by various committees that specify design requirements and tests. Harmonised standards are often used as a method of demonstrating that a product meets the essential requirements of CE marking directives. In terms of CE marking, the use of standards are generally optional but sensible/easy. Harmonisation/Harmonised standards – In this sense, harmonisation is the term for the acceptance of something throughout the EU. In terms of standards, a ‘harmonised standard’ is one that is the same throughout the EU, barring the language. So a German and French manufacturer producing the same products would work to the same standard. When a standard is accepted by the European Commission and it is referenced in their Official Journal, it is considered harmonised to the referenced directive. In these cases, meeting the requirements of the harmonised standard gives a presumption of conformity that the essential requirements of the directive have been met – this is why the CE marking process generally involves meeting the requirements of standards. Essential Requirements/Essential Safety Requirements/ESRs – These are the main points in the directives that must be met before you can claim you have complied with the directive. They are generally expanded in detail in harmonised standards, but it must be borne in mind that it is always the ESRs of the directives that you must meet. Notified Body – These are government appointed test houses that have a particular status when assessing certain products to specific CE marking directives. Generally, CE marking is a self-certification process, but some directives specifically demand the involvement of a Notified Body. Their word is basically law on determining whether a product meets the requirements of the directives or not. Checklist –The crux of the Technical File is proving that the product meets the ESRs of the applicable directives. A way to do this is to create checklists of the requirements (of the directives and/or standards) and record how the product met these requirements. Also, if a product does not meet any particular clause of a standard but arguably still meets the ESRs, the checklist is a good place to document the argument.
