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'Blue Guide' on the Implementation of EU Products Rules 2016

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'Blue Guide' on the Implementation of EU Products Rules 2016 26.7.2016 EN Official Journal of the European Union C 272/1 II (Information) INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION COMMISSION NOTICE The ‘Blue Guide’ on the implementation of EU products rules 2016 (Text with EEA relevance) (2016/C 272/01) TABLE OF CONTENTS Page PREFACE IMPORTANT NOTICE 1. REGULATING THE FREE MOVEMENT OF GOODS .................................................................................... 5 1.1. A historical perspective .......................................................................................................... 5 1.1.1. The ‘Old Approach’ ..................................................................................................... 6 1.1.2. Mutual Recognition ..................................................................................................... 7 1.1.3. The ‘New Approach’ and the ‘Global Approach’ ................................................................. 7 1.2. The ‘New Legislative Framework’ .............................................................................................. 9 1.2.1. The concept ............................................................................................................... 9 1.2.2. The legal nature of the NLF acts and their relationship to other EU legislation .......................... 10 1.2.3. How the system fits together ......................................................................................... 11 1.3. The General Product Safety Directive ......................................................................................... 12 1.4. The legislation on product liability ............................................................................................ 12 1.5. Scope of the Guide ................................................................................................................ 13 2. WHEN DOES UNION HARMONISATION LEGISLATION ON PRODUCTS APPLY? .............................................. 15 2.1. Product coverage ................................................................................................................... 15 2.2. Making available on the market ................................................................................................ 17 2.3. Placing on the market ............................................................................................................ 18 2.4. Products imported from countries outside the EU ......................................................................... 20 C 272/2 EN Official Journal of the European Union 26.7.2016 2.5. Putting into service or use (and installation) ................................................................................ 21 2.6. Simultaneous application of Union harmonisation acts .................................................................. 22 2.7. Intended use/misuse ............................................................................................................... 23 2.8. Geographical application (EEA EFTA states, Overseas Countries and Territories (OCTs), Turkey) .............. 24 2.8.1. Member States and Overseas countries and territories .......................................................... 24 2.8.2. EEA EFTA states .......................................................................................................... 25 2.8.3. Monaco, San Marino and Andorra .................................................................................. 25 2.8.4. Turkey ...................................................................................................................... 26 2.9. Transitional periods in the case of new or revised EU rules ............................................................. 27 2.10. Transitional arrangements for the EU declaration of conformity as a result of the alignment to Decision No 768/2008/EC .................................................................................................................. 27 3. THE ACTORS IN THE PRODUCT SUPPLY CHAIN AND THEIR OBLIGATIONS .................................................. 28 3.1. Manufacturer ........................................................................................................................ 28 3.2. Authorised representative ........................................................................................................ 32 3.3. Importer ............................................................................................................................. 33 3.4. Distributor ........................................................................................................................... 34 3.5. Other intermediaries: Intermediary service providers under the E-commerce Directive .......................... 37 3.6. End-user .............................................................................................................................. 38 4. PRODUCT REQUIREMENTS ................................................................................................................. 39 4.1. Essential product requirements ................................................................................................. 39 4.1.1. Definition of essential requirements ................................................................................. 39 4.1.2. Conformity with the essential requirements: harmonised standards ......................................... 40 4.1.3. Conformity with the essential requirements: other possibilities .............................................. 51 4.2. Traceability requirements ........................................................................................................ 51 4.2.1. Why does Traceability matter? ........................................................................................ 52 4.2.2. Traceability provisions .................................................................................................. 52 4.3. Technical documentation ........................................................................................................ 56 4.4. EU declaration of conformity ................................................................................................... 57 4.5. Marking requirements ............................................................................................................ 58 4.5.1. CE marking ................................................................................................................ 58 4.5.2. Other mandatory markings ........................................................................................... 64 5. CONFORMITY ASSESSMENT ................................................................................................................ 65 5.1. Modules for conformity assessment ........................................................................................... 65 5.1.1. What is a conformity assessment? ................................................................................... 65 5.1.2. The modular structure of conformity assessment in Union harmonisation legislation ................. 65 5.1.3. Actors in conformity assessment — Positioning of conformity assessment in the supply chain ..... 66 26.7.2016 EN Official Journal of the European Union C 272/3 5.1.4. Modules and their variants ............................................................................................ 69 5.1.5. One- and two-module procedures — Procedures based on type (EU-type examination) ............... 69 5.1.6. Modules based on quality assurance ................................................................................ 70 5.1.7. Overview of modules ................................................................................................... 70 5.1.8. Overview of procedures ................................................................................................ 73 5.1.9. Rationale for selecting the appropriate modules ................................................................. 74 5.2. Conformity assessment bodies .................................................................................................. 75 5.2.1. Conformity assessment bodies and notified bodies .............................................................. 75 5.2.2. Roles and responsibilities .............................................................................................. 76 5.2.3. Competence of Notified bodies ....................................................................................... 78 5.2.4. Coordination between notified bodies .............................................................................. 79 5.2.5. Subcontracting by notified bodies ................................................................................... 79 5.2.6. Accredited in-house bodies ............................................................................................ 81 5.3. Notification ......................................................................................................................... 81 5.3.1. Notifying authorities .................................................................................................... 81 5.3.2. Notification process ..................................................................................................... 82 5.3.3. Publication by the commission — the NANDO website ....................................................... 85 5.3.4. Monitoring of the competence
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