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ICTtrain Project

ICTtrain Project. New Approach. Agenda. Single Market Regulatory Policy New Approach – General Principles New Approach Directives Structure Conformity Assessment Standardisation Examples of Procedures Conclusions. Single Market Principles. Single market regulatory policy:

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ICTtrain Project

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  1. ICTtrain Project New Approach New Approach

  2. Agenda • Single Market Regulatory Policy • New Approach – General Principles • New Approach Directives Structure • Conformity Assessment • Standardisation • Examples of Procedures • Conclusions New Approach

  3. Single Market Principles • Single market regulatory policy: • Flexible regulatory framework providing access to the single market • Contribution to the design, implementation and improvement of a regulatory framework • Protection of the essential public requirements • Principle of mutual recognition of national legislations • Usage of the New Approach legislative technique and recoursing to the European Standardisation System • Facilitating the operation and competitiveness of enterprises • Prevention of new barriers to trade • Commision is committed to monitor compliance to better regulation principles in the Member States. • Single market regulatory policy also aims to facilitate access to third markets New Approach

  4. Single Market Policy – Main Actions • The protection of the principle of free movement of goods. • The promotion of European standardisation. • The promotion of better regulation principles and the development of a simplification programme of the existing regulations. • The assessment of the transposition of the acquis by candidate countries. • The development of policy on implementation of WTO/TBT agreement. • the application of the New and Global Approaches New Approach

  5. Single Market Policy – Main Actions • The protection of the principle of free movement of goods • National barriers to the free movement of goods within the EU be removed. • On-going harmonisation process in the Community • In the absence of harmonised of legislation, EC Treaty forbids Member States from maintaining or imposing intra-Community trade barriers (except in special circumstances) • Treaty prohibits quantitative restrictions on imports, exports or goods in transit and all similar measures (it is not unconditional provision) • The Commission monitors effective application of the principle • The Commission may and is obliged to bring an action only after The European Court of Justice passes a sentence New Approach

  6. Single Market Policy – Main Actions • The promotion of European standardisation • Standardisation is a voluntary process • It is carried out by independent standards bodies • Stakeholders consensus (i.e. industry, SMEs, consumers, workers, environmental NGOs, public authorities, etc.) • CEN, CENELEC and ETSI - The EU Standards Organisations • Standarisation supports innovations • 'Towards an increased contribution from standardisation to innovation in Europe’ Brussels, 11.03.2008 COM(2008) 133 final – Commission Communication • Standardisation has contributed to the support of the completion of the Internal Market in the context of the New Approach legislation • Standardisation supports EU policies related to competitiveness, ICT, public procurement, interoperability, environment, transport, energy, consumer protection, etc. New Approach

  7. Single Market Policy – Main Actions • The promotion of better regulation principles: • Process of updating existing rules to make them clear • Withdrawing a number of pending legislative proposals • Strategy for the simplification of the regulatory environment /COM(2005) 535 final/ key issues: • Usage of the stakeholders’ practicalexperience • Modified regulatory approach - co-regulation • FromDirectives to Regulations • FromDirectives to Regulations • Well defined aim - app. 300 legal acts /5000 pages/ in the OJEU will be removed from the EC statute book. New Approach

  8. Single Market Policy – Main Actions • The assessment of the transposition of the acquis by candidate countries and the contribution to the development of their quality infrastructures. • Negotiation and implementation of PECAs (Protocols to Europe Agreements on Conformity Assessment and Acceptance  of Industrial Products) • Management fo the Customs Union with Turkey • Technical assistance • Co-operation projects New Approach

  9. Single Market Policy – Main Actions • The development of policy on implementation of WTO/TBT agreement. • Negotiations with WTO (World Trade Organisation) • Implementation of the international agreements like WTO Agreement on Technical Barriers to Trade • Mutual Recognition Agreements (MRAs) promotes trade between the EU and third countries • Promotion of the regulatory convergence • Administrative co-operation • Solutions for market access problems • Promotion of our own regulatory approach New Approach

  10. Pillars of New Approach • New Approach to the Technical Harmonisation and Standards • 3 Pillars of the New Approach • Council Resolution of 07.05.1985, where a 'New Approach to technical harmonization and standards’. • Council Resolution of 21.12.1989 on a Global Approach to certification and testing, which states the guiding principles for Community policy on conformity assessment.  • The Global Approach was completed by Council Decision 93/465/EEC by defining the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking New Approach

  11. New Regulatory Technique • Basic principles: • Legislative harmonisation is limited to essential requirements that products placed on the Community market must meet, if they are to benefit from free movement within the Community. • Requirements are legal, not technical • The technical specifications of products meeting the essential requirements set out in the directives are laid down in harmonised standards. • Limited to harmonisation of safety, health and environmental essential requirements • Harmonised standards remain voluntary and manufacturers can use other methods. Other standards remains voluntary, and the manufacturer may always apply other technical specifications to meet the requirements. • Products manufactured in compliance with harmonised standards benefit from a presumption of conformity with the corresponding essential requirements (when not compliant with h. standards). When complying with harmonised standards presumed to comply with the Directive and hence free circulation within the EU • Technical solutions to meet these requirements laid down in harmonised standards developed by European Standardisation Organisations New Approach

  12. Policy on Conformity Assessment • A consistent approach is developed in Community legislation by devising modules for the various phases of conformity assessment procedures, finally, for the use of the CE marking. • The use of European standards (EN ISO 9000 series), (EN 45000 series) • Setting up of accreditation systems and the use of inter-comparison techniques are promoted in Member States. • Mutual recognition agreements concerning testing and certification in the non regulatory sphere are promoted. • The differences of existing quality infrastructures between MS are minimised by programmes. • International trade between the Community and third countries is promoted by means of mutual recognition agreements, cooperation and technical assistance programmes. New Approach

  13. Principles of Conformity Assessment • The conformity assessment is based on: • manufacturers’ internal design and production control activities; • third party type examination combined with manufacturers’ internal production control activities; • third party type or design examination combined with third party approval of product or production quality assurance • systems, or third party product verification (5); • third party unit verification of design and production; or • third party approval of full quality assurance systems. New Approach

  14. New Approach Directives • Basic common principles: • Harmonisation is limited to essential requirements. • Only products fulfilling the essential requirements may be placed on the market and put into service. • Harmonised standards, the reference numbers of which have been published in the Official Journal and which have been transposed into national standards, are presumed to conform to the corresponding essential requirements. • Application of harmonised standards or other technical specifications remains voluntary, and manufacturers are free to choose any technical solution that provides compliance with the essential requirements. • Manufacturers may choose between different conformity assessment procedures provided for in the applicable directive. New Approach

  15. New Approach Directives • Main issues: • Scope • Placing on the market and putting into service • Responsibilities • Essential requirements • Free movement • Presumption of conformity • Safeguard clause • Conformity assessment • Notified bodies • CE marking • Coordination of implementation • Transposition and transitional provisions New Approach

  16. Adoption of Directives New Approach

  17. Scope • New Approach directives apply to products which are intended to be placed (or put into service) on the Community market for the first time. • It is the responsibility of the manufacturer to verify whether it is a matter of one or more directives. • Products that have been subject to important changes may be considered as new products. This has to be assessed on a case-by-case basis. • Products, which have been repaired without changing the original performance, purpose or type, are not subject to conformity assessment. • Products specially or exclusively intended for military or police purposes are explicitly excluded from the scope of certain New Approach directives. New Approach

  18. Out of Scope • Applied since resolution except certain areas: • Foodstuffs, • Chemical products, • Pharmaceutical products, • Motor vehicles • Tractors The R&TTE and EMC Directives

  19. Placing on the Market • Placing on the market is the initial action of making a product available. • Placing on the market is the initial action of making a product available. • Physical presence on the territory of th EU does not mean that products are placed. • A product must comply with the applicable New Approach directives when it is placed on the Community market for the first time and put into service. • Member States are obliged: • not to prohibit, restrict or impede the placing on the market and putting into service of products that comply • to take measures to ensure that products not endanger the safety and health of persons, or other interests. New Approach

  20. Responsibilities • Manufacturer is responsible for: • for designing and manufacturing the product in accordancewith essential requirements laid down by the directive(s); • for carrying out conformity assessment in accordancewith the procedure(s) laid down by the directive(s). • Authorised Representative • Must be inside the Community – it tooks administrative responsibity • Is not be responsible for the manufacturing process • The manufacturer remains generally responsible for actions carried out by an authorised representative on his behalf. • Importer • Person responsible for placing on the market products from third countries • Distributor • Assembler or/and Istaller • User • Directives do not lay down obligations for users, apart from those related to putting into service. • Community legislation concerning the H&S of the workplace has an impact on the maintenance and use of products covered by New Approach directives that are used at theworkplace. • Product liability issue New Approach

  21. Essential Requirements • Essential requirements lay down the necessary elements for protecting the public interest. • Essential requirements are mandatory. Only products complying with essential requirements may be placed on the market and put into service. • Essential requirements must be applied as a function of the hazards inherent to a given product. New Approach

  22. Presumption of Conformity • Conformity with a national standard that transposes a HS, confers a resumption of conformity with the essential requirements of the applicable directive that is covered by such a standard. • References (such as titles, identification numbers) of HS are published in the OFEU. • Member States must publish the reference of the national standard that transposes a HS. • The application of HS, which give a presumption of conformity, remains voluntary in the field of New Approach directives. • The product may be manufactured directly on the basis of the essential requirements. New Approach

  23. New Approach Directives (1) • Low voltage equipment (73/23/EEC, amendment 93/68/EEC) • Toys (88/378/EEC, amendment 93/68/EEC) • Electromagnetic compatibility (89/336/EEC, amendments 92/31/EEC, 93/68/EEC, 2004/108/EC) • General product safety (92/59/EEC) • Personal protective equipment (89/686/EEC, amendments 93/68/EEC, 93/95/EEC and 96/58/EC) • Non-automatic weighing instruments (90/384/EEC, amendment 93/68/EEC) • Active implantable medical devices (90/385/EEC, amendments 93/42/EEC and 93/68/EEC) • Medical devices (93/42/EEC, amendment 98/79/EC) • Radio and telecommunications terminal equipment (1999/5/EC) • Cableway installations designed to carry persons (2000/9/EC) • Measuring instruments 2004/22/EEC The R&TTE and EMC Directives

  24. EU policy products New Approach (2) • Simple pressure vessels (87/404/EEC, amendments 90/488/EEC and 93/68/EEC) • Construction products (89/106/EEC) • Gas appliances (90/396/EEC, amendment 93/68/EEC) • Hot water boilers (92/42/EEC, amendment 93/68/EEC) • Civil explosives (93/15/EEC) • Medical devices (93/42/EEC, amendment 98/79/EC) • Potentially explosive atmospheres (94/9/EC) • Recreational craft (94/25/EC) • Packaging and packaging waste (94/62/EC) • Lifts (95/16/EC) • Refrigeration appliances (96/57/EC) • Pressure equipment (97/23/EC) • Machinery safety (98/37/EC, amendment 98/79/EC) • In vitro diagnostic medical devices (98/79/EC) The R&TTE and EMC Directives

  25. EU policy productsStandardisation (1) • Harmonised Standards: • Commission mandates harmonised standards from the European Standardisation Organisations (CEN, CENELEC and ETSI) • Standardisation process open and transparent • Before vote, public enquiry • Adoption based on a national weighted vote • After adoption, publication in the Official Journal. Only after publication they give presumption! • Directives provide for safeguard procedures against faulty standards • Harmonised Standards Revision • The presumption of conformity to the essential requirements apply also to the revised version of harmonised standards. • During the transitional period, both the old and the revised standards give presumption of conformity, provided that the conditions for this are met by both standards. The R&TTE and EMC Directives

  26. International Electrotechnical ITU ISO IEC Telecom Non electrotechnical European Telecom. Electrotechnical Nonelectrotechnical National Standard Organization(s) National EU policy productsStandardisation (2) The R&TTE and EMC Directives

  27. Standardisation - New Approach 1. A mandate is drawn up, following consultation with the Member States. 2. The mandate is transmitted to European standards organisations. 3. European standards organisations accept the mandate (80). 4. European standards organisations elaborate a (joint) programme. 5. The technical committee elaborates a draft standard. 6. European standards organisations and national standards bodies organise a public enquiry. 7. The technical committee considers comments. 8. National standards bodies vote/European standards organisations ratify. 9. European standards organisations transmit references to the Commission. 10. The Commission publishes the references. 11. National standards bodies transpose the European standard. 12. National authorities publish references of national standards. New Approach

  28. EU policy products Global Approach (1) • Global Approach on conformity assessment: Council Decision 93/465/EC concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and the use of EC conformity marking which are intended to be used in the technical harmonisation directives • Defines standard conformity assessment procedures to be used in new approach Directives • Hierarchy from Module A (Manufacturers Declaration) to Module H (Full Quality Assurance) • Choice linked to the risk which is regulated The R&TTE and EMC Directives

  29. EU policy products Global Approach (2) The R&TTE and EMC Directives

  30. Simplified Chart of Conformity Assessment Procedures New Approach

  31. Example 1 Flow chart for the conformity assessment procedures provided for in Directive 73/23/EEC on electrical equipment designed for use within certain voltage limits New Approach

  32. Example 2 – medical devices (Chart 1) New Approach

  33. Example 2 – medical devices (Chart 2) New Approach

  34. Conclusions • Single Market policy benefits consumers and entrepreneurs. • New Approach to the legislation proved its value. • Standardisation processes are streamlined. • Simplified access to the market of wide range of products – the main aim of the whole policy – is in great part achieved. • The success story of the New Approach opens door to new programmes for simplification of legislation. New Approach

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