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What is CE Marking?

The letters "CE" 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 legislations, in practice by many of the so-called Product Directives.* *Product Directives contain the "essential requirements" and/or "performance levels" and "Harmonised Standards" to which the products must conform. Harmonised Standards are the technical specifications (European Standards or Harmonisation Documents) which are established by several European standards agencies (CEN, CENELEC, etc).
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.

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 euro spent on advertising.

How does CE Marking affect 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 beneficial and disadvantageous:

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 labelling 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?

A total 18 countries required CE Marking before May 1, 2004. These were the 15 EU member countries: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxemburg, the Netherlands, Portugal, Spain, Sweden and United Kingdom plus the European Free Trade Association - EFTA's 3 member states: Iceland, Liechtenstein and Norway. From May 1 2004, with the enlargement of the EU, the 10 new EU member states also adopted the CE-Marking requirements.

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:

•	Appliances Burning Gaseous Fuels (AppliGas)
•	Cableway Installations to Carry Persons
•	Low Voltage Electrical Equipment
•	Construction Products
•	Equipment and Protective Systems for Used in Potentially Explosive Atmospheres
•	Explosives for Civil Uses
•	Hot Water Boilers
•	Household Refrigerators & Freezers
•	Lift
•	Machinery
•	Marine Equipment
•	Medical Devices
•	Active Implantable Medical Devices
•	In Vitro Diagnostic Medical Devices
•	Non-automatic Weighing Instruments
•	Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
•	Personal Protective Equipment (PPE)
•	Simple Pressure Vessels
•	Pressure Equipment
•	Recreational Craft
•	Toys
•	Trans-European Conventional Rail System

How do I obtain CE Marking for my product?

There are a series of steps outlined below, 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).
3	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 Risk
Many directives require products/systems with greater risks to be independently certified; this must be done by a "Notified Body". This is an organisation 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.