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Guide to the implementation of directives based on the New Approach and the Glo

Guide to the implementation of directives based on the New Approach and the Global Approach # # # # # # ## # # # # European Commission Guide to the implementation of directives based on the New Approach and the Global Approach European Commission This document is available on the Internet and can be downloaded in all 11 official EU languages from the Europa server at the following address: http://europa.eu.int/comm/enterprise/newapproach/newapproach.htm A great deal of additional information on the European Union is available on the Internet. It can be accessed through the Europa server (http://europa.eu.int). Cataloguing data can be found at the end of this publication. Luxembourg: Office for Official Publications of the European Communities, 2000 ISBN 92-828-7500-8 © European Communities, 2000 Reproduction is authorised provided the source is acknowledged. Printed in Italy Guide to the implementation of directives based on the New Approach and the Global Approach FOREWORD The single market is one of the great achievements of our time. This economic space, where goods, services, capital and labour can circulate freely, provides a foundation for prosperity in the European Union as we move towards the 21st century. The European Union has developed original and innovative instruments to remove the barriers to free circulation of goods. Among these, the New Approach to product regulation and the Global Approach to conformity assessment take pride of place. The common thread between these complementary approaches is that they limit public intervention to what is essential and leave business and industry the greatest possible choice on how to meet their public obligations. Since 1987 some 20 directives, adopted on the basis of the New Approach and the Global Approach, have progressively come into force. The operation of any innovative system inevitably raises questions. A first Guide, intended to answer some of these, was published in 1994. This has now been updated and rewritten, on the basis of experience. We hope that this Guide will be helpful to those who want to do business in the single market and that it will assist those whose job it is to manage the market place. It will be an invaluable aid to the candidate countries of central and eastern Europe in taking over the New Approach and the Global Approach and the directives adopted following them. We dare to hope that it will also contribute to better understanding of these methods in other countries and may even lead them to adopt similar principles. A Guide can, at best, only draw out the meaning, significance and practical consequences of the directives to which it refers. It cannot replace a legal text, or change what the legislator has decided. However, it can elucidate the legal text by bringing to bear knowledge of the usage of the European Union and the provisions of the European Community Treaty and its derived law, including the case law of the European Court of Justice. The European Commission is uniquely well placed to do this. It has consulted widely in preparing the Guide and all opinions have been carefully considered. The Guide has been discussed with the Senior Officials Group on Standardisation and Conformity Assessment Policy, who agreed to its publication. As far as possible, it reflects a broad consensus. While this does not mean that it is the last word on anything, it certainly means that it represents an authoritative expression of opinion. This Guide has been drawn up by the Directorate-General for Enterprise in close cooperation with other Commission serv- ices, with contributions from Member State experts and interest groups. My thanks to all who have contributed to this enterprise. Magnus Lemmel Acting Director-General Directorate-General for Enterprise September 1999 3 IMPORTANT NOTICE This Guide is intended to contribute to better understanding of directives based on the New Approach and the Global Approach, and to their more uniform and coherent application across different sectors and throughout the single market. It is addressed to the Member States. It is also intended to be a manual for others who need to be informed of the provisions designed to ensure the free circulation of CE marked prod- ucts as well as a high level of protection throughout the Community (such as trade associa- tions, consumer associations, standards bodies, manufacturers, importers, distributors, conformity assessment bodies, trade unions). It reflects the state of the art. Therefore, the guidance offered may be subject to modifica- tions in the future. Only the text of the directive is authentic in law. Accordingly, the text of the directive is appli- cable where there are differences between the provisions of a directive and the contents of this Guide. In particular, these differences are due to slightly divergent provisions in the indi- vidual directives, which cannot be fully described in this Guide. The focus of this Guide is on the New Approach and the Global Approach. However, products covered by directives based on the principles of the New Approach and the Global Approach may also be subject to other provisions of Community law, which are not presented in this Guide. The guidance offered to the Member States in this Guide also applies to Iceland, Liechten- stein and Norway as signatories of the Agreement on the European Economic Area (EEA). References to the Community or the single market are, accordingly, to be understood as referring to the EEA, or to the EEA market. 4 1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 1.1. Concept of the New Approach and the Global Approach . .7 1.2. Standard elements of New Approach directives . . . . . . . .8 1.3. Adoption of New Approach directives . . . . . . . . . . . . . .10 1.4. Transposition of New Approach directives . . . . . . . . . . .11 1.5. New Approach directives . . . . . . . . . . . . . . . . . . . . . .12 2. Scope of New Approach directives . . . . . . . . .15 2.1.Products submitted to directives . . . . . . . . . . . . . . . . . .15 2.2. Simultaneous application of directives . . . . . . . . . . . . . .16 2.2.1. New Approach directives . . . . . . . . . . . . . . . . . . . . .16 2.2.2. New Approach directives and the Directive on general product safety . . . . . . . . . . . . . . . . . . . . . . . . . . .17 2.2.3. New Approach directives and the Directive on product liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17 2.3. Placing on the market and putting into service . . . . . . . .18 2.3.1. Placing on the market . . . . . . . . . . . . . . . . . . . . . .18 2.3.2. Putting into service . . . . . . . . . . . . . . . . . . . . . . . .19 2.4. Transitional period . . . . . . . . . . . . . . . . . . . . . . . . . . .19 3. Responsibilities . . . . . . . . . . . . . . . . . . . . . . . .21 3.1. Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 3.1.1. New Approach directives . . . . . . . . . . . . . . . . . . . . .21 3.1.2. The Directives on product liability and general product safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22 3.2. Authorised representative . . . . . . . . . . . . . . . . . . . . . .22 3.3. Importer/person responsible for placing on the market . .23 3.4. Distributor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 3.5. Assembler and installer . . . . . . . . . . . . . . . . . . . . . . .24 3.6. User (employer) . uploads/Management/ blue-guide.pdf