Primer on Standards - OEK - OVE

The Role of European Standards in New Approach DirectivesHarmonized Standards are European Standards (EN), adopted by one of theEuropean Standards Organizations, that are prepared in accordance with theGeneral Guidelines agreed between the European Commission and the EuropeanStandards Organizations following a mandate issued by the Commission afterconsultation with the EU Member States.Harmonized standards exist when the European Standards Bodies formally presentto the Commission the European Standards they have elaborated in conformitywith the mandate they have received. Standards become harmonized when theyfulfill the corresponding requirements set in the EU Directives. The Commissionpublishes the references of these harmonized standards in its Official Journal, theOJEC *.Basically, the application of harmonized standards deems to fulfill the essentialrequirements set by the New Approach Directives. Harmonized standards are theonly ones to provide presumption of conformity with the European legal frameworkbut their application remains voluntary. So, where is the trick then?Standards, whether harmonized or not, are voluntary. However, products mustcomply with legislation. In other words, the manufacturer may not follow thegiven standards but must in all cases comply with the law (in terms of essentialrequirements). He may do so following other means. If the product is safe, hemay place it on the market, although he has to carry the burden of proof.We may rephrase the above concept into this: harmonized standards, either issuedby CENELEC, CEN or ETSI are the only ones in the world helping manufacturerscomply with the law. This happens once the reference of the harmonized standardhas been published in the OJEC. One exception only: for the Low Voltage Directive,(LVD), publication in the OJEC may not even be necessary before presumption ofconformity is granted. The LVD Directive is the only one providing presumptionof conformity according to the text of the standard itself, and there is no needto wait for publication in the OJEC.The application of harmonized standards provides presumption of conformitytowards the authorities, a guarantee of recognition towards consumers, andcompliance becomes automatically demonstrated.* For reasons of easy reading, by the notion harmonized standards is understood all European standards offered byone of the ESOs prepared in accordance with the General Guidelines agreed between the Commission and the ESOs,following a mandate issued by the Commission after consulation of the member states through the Committee98/34 and for which references have been published in the OJEC.34 CENELEC. <strong>Primer</strong> on Standards