what_is_ce_marking
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The CE marking indicates that a product complies with relevant European health, safety and environmental protection standards. It allows for the free circulation of products within the European Economic Area. The CE marking involves carrying out a risk analysis, writing instructions, drafting a declaration of conformity, and preparing a product dossier to demonstrate compliance. It facilitates trade by harmonizing safety standards across Europe.
what_is_ce_marking
- 1. What is CE marking? Introduction The CE mark has existed in its present form since 1993. Many European products bear this mark. CE stands for ‘Conformité Européenne’, meaning ‘conforms to EC Directives’. This indicates that the product may be traded freely within the European Economic Area (EEA) because it meets the requirements of the EC directives. The EEA consists of the Member States of the EU and a number of members of the European Free Trade Association who have opted to join. They are Norway, Iceland and Liechtenstein. It is the manufacturer who has to apply the marking and who is responsible for the correct implementation of the EC directives. However there are many others who are also involved with CE marking. Designers, dealers, buyers, employers and users are all accountable for the correct application of the requirements. Free trade is not possible without obligations The primary aim of CE marking is to facilitate free trade of products within the EU by reducing the effect of the physical borders between the Member States. A secondary, though by no means less important, aim is the harmonisation across the EU of the legal requirements for safety, health and the environment. This relates to both safety at work and protection of the public interest. The CE mark on a product indicates that the manufacturer or the importer for the EEA has respected the requirements for safety, health and the environment. These requirements are set out in EC-directives. The Member States have committed themselves to incorporating these exact requirements into their national legislation. This will result in the harmonisation of all legislation in this field throughout the EU.
- 2. What is CE marking? 2 CE marking usually involves the following obligations: Carrying out a risk analysis for the product. What hazards could be caused by the product? How great is the risk to people, animals, goods or the environment? What solutions can be applied to reduce risks in compliance with the appropriate EC directive? Writing a user’s instruction manual. This should also set out the purpose for which the product is intended. The manual should be written in the language of the user. Drafting an EC declaration of conformity. The manufacturer (or the importer for the EEA) declares that the product complies with the specified EC directives and norms. Preparing a product dossier . This will include in all cases the documents mentioned above, as well as design data, drawings, calculations and test reports. In other words, it contains everything which makes it possible to demonstrate that the essential requirements relating to CE marking have been met. A bit of history Back in the ‘old days’ every European country had its own trade regulations. This made life expensive as for each country you wanted to trade with your product had to be approved under the national legislation, frequently by an expert body. With the founding of the EC central directives were established with which products had to comply. This was the system used for product safety until about 1987. However the excessively severe regulation was a barrier to product development. Too many detailed technical requirements were imposed on products. Furthermore, the European Council had to approve any decision unanimously. There was no central policy for product liability. This route was abandoned in 1985 and the Old Approach disappeared. The New Approach The change to less direct governmental involvement in the details of a product made it possible to introduce a whole new phenomenon in the area of legislation. Goods can now be traded freely within the European Economic Area (EEA). The basis for this was the idea that the greatest barriers to trade were linked to safety aspects which required too much detailed negotiation to achieve approval by all Member States. Thus for various product groups general requirements were defined and set out (in clear and unambiguous language) in the New Approach directives which were approved by all Member States. A CE mark on a product indicates that it complies with the requirements. For as many products as possible the obligatory national approval procedures have been abolished throughout the EEA. Manufacturers (or importers) must now ensure that they meet the legal requirements and must be able to provide evidence of this should problems arise. To this end a system has been devised which brings together quality assurance and the assessment of conformity with the EC directives. CE marking is self-certification, which is particularly good for small and medium companies. Only in exceptional cases, for example for specific dangerous machines or for large pressure valves, is it necessary to consult an external expert (a Notified Body) which will examine those aspects of the product and issue a declaration.
- 3. What is CE marking? 3 The national authorities ensure that random testing takes place to ascertain whether procedures are being followed correctly. The EC directives form a legal obligation. This harmonisation means that for many product groups the same laws on safety, health, the environment and consumer protection apply throughout the EU. Harmonised standards In order to assist the manufacturer (or importer) with the conformity assessment of a product, standards which apply across the EEA are being drafted at a relatively high rate. They are known as harmonised standards and can be recognise as such by the indication EN before the standard number. Many of these standards make it possible to do without an extensive risk analysis. By adhering closely to the articles of the standard it can be assumed that there is a ‘presumption of conformity’ with the relevant EC directives. In contrast to the EC-directives the standards are very technical. Standards can be much more easily adapted to take account of current technical developments. EN-standards are not mandatory but often serve as a very useful tool. Product liability Since the introduction of CE marking product liability in a European framework has become much more strictly controlled in order to avoid an 'American situation'. There is a separate directive which only applies only to products which do not meet the essential requirements. It is now up to the manufacturer, or his representative, to demonstrate that things are in order on delivery. In order to receive compensation the victim must be able to prove that the damage was caused by the product. However, he does not have to prove that the manufacturer has been negligent. Applying CE-marking The CE marks are applied by the manufacturer or the importer for the EEA. The CE logo should be clearly visible on the product (or on the packaging if there is no space on the product). In conjunction with the EC declaration of conformity the manufacturer is stating here that the product meets the requirements of the EC directives for CE marking. These are usually New Approach directives, but there are also a few other directives that affect CE marking, such as some of the Global Approach directives.
- 4. What is CE marking? 4 EC-directives for CE-marking, in accordance with the New Approach EC-directive Subject Compulsory Document no. with (amendment) Low voltage directive Products with a voltage rating of 1997-01-01 50-1000 V AC or 75-1500 V DC Replaced by codified version 2007-01-16 2006/95/EC Simple pressure Welded vessels with a pressure 1992-07-01 vessels greater than 0,5 bar intended to contain air or nitrogen Replaced by codified version 2009-10-28 2009/105/EC Toys Products designed or intended for 1990-01-01 88/378/EEC use in play by children of less than (93/68/EEC) 14 years of age Replaced first phase 2011-07-20 2009/48/EC Replaced complete 2013-07-20 Construction Products for incorporation in a 1991-06-27 89/106/EEC products permanent manner in construction (93/68/EEC) works (buildings and civil engineering works) Electromagnetic Apparatus liable to cause 1996-01-01 Compatibility (EMC) electromagnetic disturbance or which is liable to be affected by such disturbance Replaced by new version 2007-07-20 2004/108/EC Personal protective Appliances designed to be worn or 1995-07-01 89/686/EEC equipment held by an individual for protection (93/68/EEC) against health and safety hazards. (93/95/EEC) (96/58/EC) Non-automatic Weighing instruments requiring the 2003-01-01 weighing instruments intervention of an operator Replaced by codified version 2009-06-05 2009/23/EC Active implantable Electrically driven medical devices 1995-01-01 90/385/EEC medical devices implanted in the human body (93/42/EEC) (93/68/EEC) 2010-03-21 (2007/47/EC)
- 5. What is CE marking? 5 EC-directives for CE-marking, in accordance with the New Approach EC-directive Subject Compulsory Document no. with (amendment) Appliances burning Appliances burning gaseous fuels 1996-01-01 gaseous fuels used for cooking, heating, hot water production, refrigeration, lighting or washing Replaced by codified version 2010-01-05 2009/142/EG Efficiency Efficiency requirements applicable to 1998-01-01 92/42/EEC requirements for hot new hot-water boilers fired by liquid (93/68/EEC) water boilers or gaseous fuels (2004/8/EC) (2005/32/EC) (2008/28/EC) Explosives Explosives for civil uses 2003-01-01 93/15/EEC Medical devices Medical devices (general) 1998-06-14 93/42/EEC (98/79/EC) (2000/70/EC) (2001/104/EC) 2010-03-21 (2007/47/EC) Equipment in Equipment and protective systems 2003-07-01 94/9/EC explosive intended for use in potentially atmospheres (ATEX) explosive atmospheres Recreational craft Craft intended for sport and leisure 1998-06-16 94/25/EC purposes (2003/44/EC) Lifts Lifts permanently installed in 1999-06-30 95/16/EC buildings and constructions 2009-12-29 (2006/42/EC) Pressure equipment Pressure equipment and assemblies 2002-05-29 97/23/EC with a maximum allowable pressure greater than 0,5 bar Machinery directive Machinery 1995-01-01 Replaced 2009-12-29 2006/42/EC Modification regarding machinery for pesticide application 2011-12-15 (2009/127/EC) Medical devices for Medical devices intended for in-vitro 2003-12-07 98/79/EC in-vitro diagnostics examination of specimens derived from the human body
- 6. What is CE marking? 6 EC-directives for CE-marking, in accordance with the New Approach EC-directive Subject Compulsory Document no. with (amendment) Radio and Equipment that is either radio 2000-04-08 1999/5/EC telecommunications equipment or telecommunications terminal equipment terminal equipment or both Cableway Cableway installations designed to 2004-05-03 2000/9/EC installations carry persons Measuring Devices or systems with a 2006-10-30 2004/22/EC instruments measurement function (2006/96/EC) Modification 2011-06-01 (2009/137/EC) Pyrotechnic articles Fireworks category 1, 2, 3: 2010-07-04 2007/23/EC Fireworks category 4, other 2013-07-04 pyrotechnical articles, and those for theatrical use. EC-directives for CE-marking, in accordance with the New Approach and the Global Approach EC-directive Subject Compulsory Document no. with (amendment) Refrigeration Energy efficiency requirements for 1999-09-03 1996/57/EC equipment household electric refrigerators, (2005/32/EC) freezers and combinations thereof (2008/28/EC) Replaced 2010-07-01 2005/32/EC Transportable pressure Safety within the EU of nationally 2001-07-01 1999/36/EC equipment approved portable pressure (2002/50/EC) equipment (∏ mark) Noise emission Noise emission in the environment 2002-01-03 2000/14/EC by equipment for use outdoors (2005/88/EC) Ballasts Energy efficiency requirements for 2002-04-08 2000/55/EC ballasts for fluorescent lighting (2005/32/EC) (2005/28/EC) Replaced 2010-07-01 2005/32/EC