'Does the CE Marking Apply?'The CE Marking applies only to products placed in the market or put intoservice in the European Economic Area, and only for a certain number of productgroups or product aspects. So to answer the question whether the CE Markingapplies, one has to determine first if the countries in which the products aregoing to be placed in the market or used are countries that require CE Marking.Secondly, it must be checked if the product, or some of its aspects, are withinthe field of application of the CE Marking regulations.1. The CE Marking is only applicable in the following countries:A) The twenty-seven Member States of the European Union (EU):Austria (became member in 1995)Belgium (Founder Member in 1957)Bulgaria (2007)Czech Republic (2004)Cyprus (2004)Denmark (1973)Estonia (2004)Finland (1995)France (FM 1957)Germany (FM 1957)Greece (1981)Hungary (2004)Ireland (1973)Italy, (FM 1957)Latvia (2004)Lithuania (2004)Luxembourg (FM 1957)Malta (2004)The Netherlands (FM 1957)Poland (2004)Portugal (1986)Romania (2007)Slovakia (2004)Slovenia (2004)Spain (1986)Sweden (1995)United Kingdom (Great Britain) (1973)B) The following three members of the European Free Trade Association (EFTA):IcelandNorwayLiechtensteinAlthough Switzerland is member of the EFTA, it does not directly apply the CEMarking. However, Switzerlandhas signed a mutual recognition agreement with the European Union. For some CEMarked products, the Swiss authorities presume they comply with the equivalentSwiss regulations.C) The following countries that seek to become Member States of the EuropeanUnion:- Turkey: Turkey has transposed many of the European CE Marking regulationsinto their national legislation, and requires CE Marking for many products.- Croatia:Most CE Marking regulations have been transposed in Croatian legislation.Products with CE Marking are going to be accepted as products presumed tocomply with Croatian legislation. Croatia is expected to become afull member of the EU in 2009-2010.- Bosnia and Herzegovina:Bosnia and Herzegovinahas started the process of transposing CE Marking regulations in their nationalstate legislation. Products with CE Marking are accepted as products presumedto comply with national legislation.- Albania:Albaniahas started the process of transposing CE Marking regulations in their nationalstate legislation. Products with CE Marking are accepted as products presumedto comply with national legislation.- FYR Macedonia:FYR Macedoniahas started the process of transposing CE Marking regulations in their nationalstate legislation. Products with CE Marking are accepted as products presumedto comply with national legislation.- Serbia:Serbiahas recently started to approximate towards membership of the European Union.It is expected that in the next years the CE Marking regulations will betransposed in their national state legislation, and that products with CEMarking are accepted as products presumed to comply with national legislation.- Montenegro:Montenegrorecently became an independent country. Its government has announced that itaims at membership of the European Union. It is expected that in the next yearsthe CE Marking regulations will be transposed in their national statelegislation, and that products with CE Marking are accepted as productspresumed to comply with national legislation.If your products are placed in the market in other than aforementionedcountries, the CE Marking does not apply.Next you should check whether the product can be considered to be of one of theproduct groups covered by the CE Marking regulations.2. The CE Marking is required only for the following types of products:-Toys-Machinery-Electrical equipment-Electronic equipment-Personal protective equipment-Pressure equipment-Medical devices-Active implantable medical devices-In vitro diagnostica-Radio and Telecommunications terminal equipment-Simple pressure vessels-Gas appliances-Lifts-Recreational craft-Equipment and protective systems for use in explosive atmospheres-Non-automatic weighing instruments-Cableways-Construction products-Explosives for civil use-New hot water boilers-Measuring EquipmentThe CE Marking is NOT required for the following products:-Chemicals-Pharmaceuticals-Cosmetics-FoodstuffsOther than mentioned product groups do not require CE Marking.Products that are not covered by the European CE Marking regulations may fallwithin the scope of other European or national legislation. If there is nospecific legislation, the General Product Safety Directive (2001/95/EC)applies. This European Directives requires that products are safe, but is doesnot require any marking.Tomorrow, we will look at determining which CE Marking directives and whichEuropean harmonized standards apply. These documents contain the requirementsand CE certification procedures that must be applied before the CE Marking maybe affixed.
Now we will look into the question how to determine which CE Marking regulationsand European harmonized standards apply.CE DirectivesCE Marking product requirements and certification procedures are laid down inEuropean technical regulations that are called 'directives'. There arecurrently almost 25 CE Marking directives for different product groups (e.g.machinery, toys, medical devices) or product aspects (e.g. electromagneticcompatibility). Please note also that more than one directive can apply to asingle product. For example, a machine with an electrical system and controlpanel is regulated by the Machinery Directive, the Low Voltage Directive andthe EMC Directive.Unfortunately, there is no list that tells you which products are covered bywhich directives. So, you must check every directive in order to determine ifit applies. European harmonized standardsEuropean harmonized standards, are product standards that have been developed,adopted and published by one of the three European standards bodies CEN,CENELEC or ETSI on a mandate by the European Commission. In other words, theEuropean legislator requested the European standards bodies to develop thesestandards. They are called 'harmonized', because the content of these standardsare harmonized with the content of the essential requirements of the directivesto which they pertain. For every CE Marking directive there is a list ofEuropean harmonized standards.The relationship between the CE Marking directives and the European harmonizedstandards is very strong. The CE Marking directives state that if your productmeets the relevant specifications of all appropriate European harmonizedstandards, it is automatically presumed to comply with the appropriate CEdirectives. In other words, if your product is approved according the Europeanharmonized standards, they can be affixed with the CE Marking, because they arepresumed to comply with the essential requirements of the CE Markingdirectives. So applying European harmonized standards provide the easiest wayof checking CE compliance.Of course it is complex to determine the applicable CE Marking directives and European harmonized standards. If you need our support, please go to:
www.cemarking.in
