1. Phare SL9705.03 1 Implementation of Technical Regulations on Company Level The System of The New Approach Expert: Frans Dooms Chamber of Commerce and Industry, Ljubljana

2. Phare SL9705.03 2 Implementation of Technical Regulations on Company Level The System of the New Approach Expert: Christèle Hubert Chamber of Commerce and Industry, Ljubljana

3. Phare SL9705.03 3 EU Legislation Member States and the legal structures to accomplish the "Unified Europe" The System of The New Approach

4. Phare SL9705.03 4 15 Member StatesStates of the EEA –Austria-- Iceland –Belgium-- Norway –Denmark-- Liechtenstein –Finland –France –Germany –Greece –Ireland –Italy –Luxembourg –The Netherlands –Portugal –Spain –Sweden –United Kingdom EU Legislation

5. Phare SL9705.03 5 European Parliament  626 Members, directly elected by the citizens of the Member States  helps to draft, amend and adopt European laws  approves the budget  approves the appointment of the Commission  has the power to censure the Commission EU Legislation EU Institutions

6. Phare SL9705.03 6 The Commission  20 Commissioners  independant from the national governments  acts as a college  makes proposals for the European Legislation  oversees the implementation of common policies EU Legislation EU Institutions

7. Phare SL9705.03 7 The Council of the European Union  one minister of each Member State  different Councils for different subjects  adopt together with the Parliament Community legislation initially proposed by the Commission The European Council  Heads of States or Governments of the Member States and the President of the Commission  meets twice a year  decides on policy lines for the Community EU Institutions EU Legislation

8. Phare SL9705.03 8 Regulations  general application, directly applicable in the Member StatesDirectives  binding the Member States, freedom for the form of implementationDecisions  binding entirely upon those to whomthey are addressedRecommandationsOpinions  have both no binding force EU Legislation Legal documents

9. Phare SL9705.03 9  Proposal by the Commission  submitted to the Council and the Parliament  having obtained the opinion of the Parliament the Council adopts a common position by a qualified majority  information of the Parliament of the common position  information of the Parliament by the Commission  when the Parliament accepts  the Council shall adopt the proposed directive  when the Parliament does not accept  counciliation is necessary  only under certain provisions the Council may adopt the directive but then by unanimity only EU Legislation Directive

10. Phare SL9705.03 10 Implementation of directives  transposition in to national law within the dates mentioned in the directive  but direct application possible for the citizens, when the Member State fails to implement the directive in time EU Legislation

11. Phare SL9705.03 11 According Art. 94, 95 (former Art. 100, 100a)  Realisation of the internal market  Transposition in national law without changes According Art. 138 (former Art. 118a)  Approximation of laws and regulations  Minimum requirements  National laws can be more stringent EU Legislation EC Directives

12. Phare SL9705.03 12 Article 138 Article 138 Article 95 Article 95 EU Legislation

13. Phare SL9705.03 13 Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards The System of The New Approach New Approach

14. Phare SL9705.03 14 Purpose of directives  approximation of laws, regulations and administrative provisions in the Member States  reduce barriers to trade  avoid repercussions on the operation of the internal market Old Style directives  detailed technical specifications in the directive  difficult to change when technical innovations are developed  lack of experts in the Commission to fullfill this task in time The System of The New Approach

15. Phare SL9705.03 15 New Approach Directives  contain requirements defining the technical characteristics of products  encompass a large number of similar products which present the same type of hazards and can therefore be defined by similar requirements  do not define technical details but state "essential requirements" valid in the whole EU  when the essential requirements are fullfilled, the legal objectives of the directive are fullfilled too.  in the legal sense only on the basis of these essential requirement alone a product will be assessed for its ability to be put on the market The System of The New Approach

16. Phare SL9705.03 16 NEW APPROACH  No technical requirements  Only essential requirements  references to standards The System of The New Approach

17. Phare SL9705.03 17 Harmonized Standards  define the technical limits for fullfilling the essential requirements of the directive  mandated by the Commission  drafted by a European Standardization Organization(CEN, CENELEC or ETSI)  voted and ratified properly according the rules of these organizations  conveyed to the Commission for publication in the Official Journal under the directive in question  transposed by all Member States into national law presumption of conformity  products made according to Harmonized Standards are expected to fulfil the essential requirements The System of The New Approach

18. Phare SL9705.03 18 Some important Directives  Low Voltage  Medical Devices  Radio and Telecom Terminal Equipment  Machinery  Explosive Atmosphere  EMC  Construction Products  Automotive  Active Implantable  Tractors and agricultural vehicles  Pressure equipment ...  over 47 directives (20 are New Approach) The System of The New Approach

19. Phare SL9705.03 19 STANDARDIZATION activity (process) of establishing provisions (appointments/specifications) for common and repeated use, aimed at the achievement of the optimum degree of order in a given context. Made (drawn up) with consensus by all relevant parties concerned. The System of The New Approach

20. Phare SL9705.03 20 STANDARDIZATION AIMS AT fitness for purpose compatibility/interchangeability variety reduction and efficiency (self)regulation of the market elimination of (technical) barriers to trade safety and health protection of the environment The System of The New Approach

21. Phare SL9705.03 21 DIRECTIVES AIM AT free movement harmonization of laws safety health environment The System of The New Approach

22. Phare SL9705.03 22 STANDARDIZATION BENEFITS reduction of enterprise risks serves the competitiveness means market opportunities market oriented application of Know-how The System of The New Approach

23. Phare SL9705.03 23 Standardisation procedure under the New Approach 1. Mandate drawn up after consultation of Member States 2. Mandate transmitted to European Standards Organisations 3. E.S.O accept the mandate and elaborate a work programme 4. Technical Committee elaborates a draft standard 5. E.S.O and National Standards Bodies organise public enquiry 6. Technical Committee considers comments The System of The New Approach

24. Phare SL9705.03 24 Standardisation procedure under the New Approach 7. National Standards Bodies vote and E.S.O ratify 8. E.S.O transmit references to the Commission 9. Commission publishes the references 10. N.S.B transpose the European standard 11. National authorities publish references of national standards The System of The New Approach

25. Phare SL9705.03 25 THE STANDARDS WORLD The System of The New Approach

26. Phare SL9705.03 26 NEW APPROACH since 1985 directive per group of products only essential requirements technical requirements by CEN/CENELEC permanent committee (judge standards) publication in the official journal The System of The New Approach

27. Phare SL9705.03 27 Conformity Assessment  Dependant of the safety problems the procedures are defined in the directive  a general common system is given in the "Global Approach" communication  even in the case of third party testing the manufacturer or his representative have to deliver a EC Declaration of conformity  The products shall bear the CE Marking to show the conformity with all directives applicable to the product The System of The New Approach

28. Phare SL9705.03 28 CONFORMITY ASSESSMENT A. Internal control of production. B. Type examination C. Conformity to type D. Production quality assurance E. Product quality assurance F. Product verification G. Unit verification H. Full quality assurance The System of The New Approach

29. Phare SL9705.03 29 DECLARATION OF CONFORMITY name and address of manufacturer identification of the product conformity to directives (if applicable) notified body (if applicable) conformity to technical file (if applicable) reference to standards responsibility of the manufacturer The System of The New Approach

30. Phare SL9705.03 30 TECHNICAL FILES Information to demonstrate conformity In the European Community To keep 10 years after last manufacture To cover design, manufacturing and operation Risk analysis Official language of member state Available for authorities The System of The New Approach

31. Phare SL9705.03 31 INSTRUCTIONS FOR USE Must be in the official languages of the country of destination e.g. Belgium = Dutch + French + German The System of The New Approach

32. Phare SL9705.03 32 NOTIFIED BODIES Nominated by the member states Notification to the Commission number of 4 digits Can subcontract under the responsability of the notified body Obligation of co-ordination (obligation of assisting standardisation) The System of The New Approach

33. Phare SL9705.03 33 CE-marking Compliance with all applicable directives internal quality control system procedure on how conformity is achieved applying the CE-mark retain documentation for 10 years The System of The New Approach

34. Phare SL9705.03 34 CE- marking The System of The New Approach

35. Phare SL9705.03 35 Fundamental explanations Placing on the market  Initial action of making availble on the Community market, against payment or free of charge, a product covered by the directive for the view to distribution and/or use in the Community  Putting a product into service  first use on the Community territory of a product refers to in the directive by its final user Manufacturer  person responsible for designing and manufacturing a product covered by the Directive, with a view to placing it on the Community market on his own behalf  Authorized representative  person appointed by the manufacturer to act on his behalf in carrying out certain tasks required by the directive The System of The New Approach

36. Phare SL9705.03 36 Safeguard clause (normally Article 9) Nonconform Products  by market surveillance or information from the competitors the authorities identify unsafe products Member State calls for an "Article 9" - case  notifies the measures taken to the Commission  withdrawing from the market  prohibiting the further placement on the market  restricting the free movement of the product  consultation with the parties concerned by the Commission  when measures are justified information of the Member States  when not, dropping the case The System of The New Approach

37. Phare SL9705.03 37 Safeguard clause challenging a Standard  if the non compliant product has been made according to a Harmonized Standard published in the Official Journal  the European Standardization Institute responsible for is addressed by the Commission to change the standard  if the standard is not amended in time it is withdrawn from the list in the Official Journal and looses its quality of providing presumption of conformity The System of The New Approach