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CE Mark Consultancy
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What is CE Marking (CE Mark)?

CE Marking is the symbol as shown opposite. The term initially used was the "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.

The Term "CE Mark" is also in use, but it is NOT the official term.

What does CE Marking Mean :-

•CE Marking on a product is a manufacturer's declaration that the product complies with the essential health & safety requirements of the relevant Article 100A, European health, safety and environmental protection legislation, also known as Product Directives.
•CE Marking on a product indicates to governments that the product may be legally placed on the market in their country.
•CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries)
•CE Marking indicates to customers that the product meets designated minimum safety standards and therefore a minimum level of quality,
•CE Marking promotes public health and safety, and enhances product credibility,
•CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement authorities.

However, many non-EU exporters are still unaware of or are unsure about this fact and its impact on their business.

The Product Directives contain the "essential health & safety requirements" and/or "performance levels" 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). To which a product may be tested or assessed, if the product conforms then this MAY give a presumption of Conformity with the relevant Directive.

CEN stands for European Committee for Standardization.
CENELEC stands for European Committee for Electro-technical Standardization.

CE Marking is mandated by New Approach Directives. Many products are covered by these directives, and to be placed on the market in the EU, some must bear CE Marking - it's a legal requirement.

Does my product require the CE marking?

You need to establish first which, if any, of the New Approach Directives or older Global Approach Directives applies to your product.

CE marking only applies to products within the scope of these Directives. It should not be applied to products if they are outside the scope of the Directives.

The European Commission's "Blue Guide" (Guide to the Implementation of Directives Based on the New Approach and Global Approach) lists Directives where the CE Marking will be applicable. It is available for download from the European Commission's website.

The same principles above apply to imported products. It is the responsibility of the importer / person placing the product on the market to ensure that the product is correctly CE-marked.

How do I go about getting a CE Marking?

This depends on which Directives apply to the product. It is impossible to draw up hard-and-fast rules, and it is important to seek independent and impartial advice if you are in any doubt. Guidance booklets on many of the EC Directives (or UK regulations implementing those Directives) that contain CE marking requirements are available. They can also be downloaded from our web sites in Acrobat format.

It is important also to understand that not all EC Directives relating to products, e.g. the General Product Safety Directive, require CE marking, nor that a particular Directive applies to all products that could be described by its title e.g. the Machinery Directive does not apply to every conceivable product that might be termed a machine.

Most of the Directives set out the 'scope' i.e. the range of products to which they apply.

Must the CE marking appear on any packaging, in manuals or other supporting literature?

In general CE marking must appear on the product but see the individual guidance for exceptions. It may also appear on the packaging, in manuals or other supporting literature, but again it is best to study the guidance.

What is the design of the CE marking, and how big / small must it appear?

The CE mark must not be less than 5mm in its vertical height, and the proportions maintained. It is generally shown on a grid in the guidance booklets, as at the top of this page (the grid does not form part of the marking and is for information only):

This mark looks the same as some previous marks, but there are subtle changes, and it should be studied closely. It should be noted, for example, that the C and E are not formed by perfect semi-circles, i.e. the top and bottom arms extend one square beyond the semi-circles, and the middle arm of the E stops one square short.

What files / documentation must I keep? What information should those contain? Ditto the Declaration of Conformity.

Please refer to the specific Directives and/or Regulations, and also our guidance documents available from our publications page or from Publications @ BERR.

Who enforces - and what would happen if I don't CE mark a product?

Enforcement varies according to the Directives. Some are enforced by local Trading Standards Departments, others by HSE and yet others by the Medical and Healthcare Products Regulatory Agency and the Vehicle Certification Agency.

Enforcement procedures/penalties: Except where safety is at risk, the relevant enforcement authority will usually provide you with an opportunity to ensure that your product is correctly CE-marked. If you fail to comply then you will be obliged to take your product off the market, and you may also be liable to a fine and/or imprisonment.

What requirements do I have to meet to export my product?

CE-marking applies to the circulation of a product within the EEA. It is not required for exporting a product to non-EEA countries. You need to check on the particular regulatory requirements or standards that apply to your product in the country in question. The same standards may apply but they may also be different.

Advice on exporting is available from the UK Trade & Investment network, which delivers services co-ordinated by the former British Trade International, the organisation set up in May 1999 to take lead responsibility within Government for trade development and promotion.

The Technical Help for Exporters service run by the BSI may also be able to offer some advice.

What are Notified / Approved / Competent Bodies? How can I find one?

These are bodies appointed by each Member State under the appropriate national regulations to conduct third-party conformity assessment procedures to the product in question or its production processes, as required by the Directives, in order that it may be CE-marked. The procedures vary according to the Directives and third-party involvement is not compulsory for all products. Manufacturers can use the services of Notified/Approved/Competent Bodies in any member State of the European Community.

Some listings of these Bodies can be obtained from the our Web Pages - or from Publications @ BERR - and others from the European Commission's web site.

What standards must my product meet? Where can I get copies?

Lists of standards that provide a presumption of conformity with the EC Directives for the purposes of CE marking are available from the "New Approach" web site. Copies of the standards can be ordered from BSI.

Where can I get specific technical help?

Technical help is available from several sources including BSI, www.sda-ltd.co.uk, www.cemark.co.uk, www.dsear.org.uk , your Trade Association, and UK Trade & Investment

CE Mark Consultancy is the trading name of CE Mark Technical Services Ltd. Registered in England No: 12389827.
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