Primer on Standards - OEK - OVE

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Legal framework of the New ApproachNew Approach Directives are based on Article 95 of the EC Treaty, and adoptedaccording to the co-decision procedure provided for in Article 251 of the EC Treaty.Adopted New Approach Directives are notified to Member States and publishedin the L series of the Official Journal of the European Communities. Commissionproposals for New Approach Directives are published in the C series of the OfficialJournal.The principles of the New ApproachNew Approach Directives are based on the following principles:Legislation is restricted to regulatory specifications that must be met beforeproducts can be placed on the European market place. These specificationsare outlined in the New Approach Directives and mainly refer to essentialrequirements that are of public interest (health and safety)The necessary standards ensuring that products meet these regulatoryrequirements are created by the competent recognized European StandardizationOrganization, CEN, CENELEC or ETSI, depending on the field of work, under acontractual relationship with the European Commission (and the EFTA Secretariat),known as a mandate. They will be called harmonized standardsThe references to harmonized standards will be published in the OJEC. It isonly from this moment that the harmonized standards will grant presumptionof conformityApplication of harmonized standards or other technical specifications remainsvoluntary. Manufacturers are always free to choose any technical solutionthat provides compliance with the essential requirements set by the Directive.This is a very important clause for it guarantees the ground for technicaldevelopment, crucial when manufacturers of new or innovative products forwhich standards do not yet exist want to certify their products according tothe legal European frameworkOnly products fulfilling the essential requirements may be placed on theEuropean market and put into serviceNational authorities must acknowledge that products manufactured inconformity to harmonized standards are presumed to conform to all thenecessary legal requirements established by the Directives32 CENELEC. <strong>Primer</strong> on Standards
Manufacturers may choose between different conformity assessment proceduresprovided for in the applicable DirectiveEssential Health and Safety RequirementsA fundamental principle of the New Approach is to limit legislative harmonizationto the essential requirements that are of public interest. These requirements dealin particular with the protection of health and safety of users (usually consumersand workers) although sometimes cover other fundamental requisites, likeprotection of the environment. Complying with the essential requirements ismandatory because they lay down the necessary elements for the protection ofthe public interest. All manufacturers are obliged to meet these legally-bindingrequirements specific to each product. Only products complying with theseessential requirements may be placed on the European market and the law doesnot distinguish between European manufacturers and manufacturers from othercountries.The above paragraph leads us to the explanation of a new concept, ConformityAssessment, that is, the process by which compliance with the essential requirementsset by the Directives is determined. This process may be carried out with or withoutthe use of standards. This principle is important to manufacturers of avant-gardeproducts for which standards do not yet exist for it ensures that harmonizedstandards do not become the only technical solution, consequently impedingtechnological development. If a manufacturer decides not to apply harmonizedstandards, he may do so and market the product directly on the basis of theessential requirements, although he will have to demonstrate compliance. Inother words: products placed on the market must comply with legislation but notnecessarily with standards.Old Approach / New ApproachThe harmonization of standards, like law and conformity assessment procedures,has greatly simplified technical regulation in Europe. Prior to harmonization, eachcountry developed its own standards through a National Standards Body. Differentsets of standards were not only costly, but also created major difficulties to tradebetween European countries. It became necessary to create a new, integrated,European system of standardization.Uncovering the mysteries of standardization in Europe 33
Page 1: Primer on Standard
Page 4 and 5: ContentsIntroductionChapter 1Introd
Page 6 and 7: IntroductionThis primer is intended
Page 8 and 9: ChapterIntroducingCENELECCENELEC, t
Page 10 and 11: CENEL, the European Committee for t
Page 12 and 13: The Central Secretariat handles all
Page 14 and 15: Documents used as a basis for CENEL
Page 16 and 17: ChapterThe EuropeanStandardWhat is
Page 18 and 19: European trade and consumers. Havin
Page 20 and 21: CENELEC Standards are of the highes
Page 22 and 23: ChapterUnderstandingthe CenelecStan
Page 24 and 25: In the case of a European standard
Page 26 and 27: New work arises at European level v
Page 28 and 29: ChapterThe CenelecConformityAssessm
Page 30 and 31: Mutual Recognition Agreements signe
Page 32 and 33: ChapterThe EuropeanStandardization
Page 36 and 37: The Role of European Standards in N
Page 38 and 39: New Approach Directives for which C
Page 40 and 41: ChapterCE Marking, ConformityAssess
Page 42 and 43: egardless of the product’s origin
Page 44 and 45: Some other products, mostly those i
Page 46 and 47: Market are governed by one (or some
Page 48 and 49: manufacturers are often approached
Page 50 and 51: COOPERATING PARTNERSAIECAPIELCEACEC
Page 52: For more information:35 rue de Stas

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