ENTERPRISE AND INDUSTRY Directive 98/34/EC: An instrument of co-operation This booklet is intended as a guide to the system set up to prevent barriers to the free movement NB-57-03-273-EN- between institutions and enterprises to ensure of products as well as the freedom of establishment and the freedom to provide services as far as the smooth functioning of the Internal Market Information Society services are concerned. The booklet provides a commentary on Directive 98/34/ EC, the legislation adopted to implement this mechanism. It covers the amendments subsequently introduced on 20 July 1998 by Directive 98/48/EC which brought about an important change to the procedure by extending it to rules on Information Society services. Each of the Directive’s provisions C is quoted in full and accompanied by a detailed commentary explaining its meaning and its implications for all interested parties: Member States, national and European standardisation bodies A guide to the procedure and, last but not least, present or potential economic operators within the European Union. for the provision of information This booklet has been prepared by the Commission departments and does not commit the Commission in any way. The text of Directive 98/34/EC, as amended by Directive 98/48/EC, is alone in the field of technical legally binding. The original language of this booklet is English. standards and regulations and of rules on Information Society services European Commission http://europa.eu.int/comm/enterprise/tris/ European Commission Directive 98/34/EC: An instrument of co-operation between institutions and enterprises to ensure the smooth functioning of the Internal Market Luxembourg: Office for Official Publications of the European Communities 2005 — 89 pp. — 29.7 x 21 cm ISBN 92-894-6917-X SALES AND SUBSCRIPTIONS Publications for sale produced by the Office for Official Publications of the European Communities are available from our sales agents throughout the world. You can find the list of sales agents on the Publications Office website (http://publications.eu.int) or you can apply for it by fax (352) 29 29-42758. Contact the sales agent of your choice and place your order. Directive 98/34/EC: An instrument of co-operation between institutions and enterprises to ensure the smooth functioning of the Internal Market A guide to the procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services European Commission 1 Europe Direct is a service to help you find answers to your questions about the European Union Freephone number (*): 00 800 6 7 8 9 10 11 (*) Certain mobile telephone operators do not allow access to 00 800 numbers or these calls may be billed. 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, 2005 ISBN 92-894-6917-X © European Communities, 2005 Reproduction is authorised provided the source is acknowledged. Printed in Italy PRINTED ON WHITE CHLORINE-FREE PAPER Table of contents Introduction Directive 98/34/EC, an instrument of transparency at the service of the Internal Market 10 Chapter I The scope of the Directive 16 Definition of terms (Article 1) 16 – product, 16 – service, 16 – technical specification, 18 – other requirement, 18 – rule on services, 19 – standard, 21 – standards programme, 23 – draft standard, 23 – European standardisation body, 23 – national standardisation body, 27 – technical regulation, 28 – draft technical regulation 32 Chapter II The procedure for the provision of information with regard to standards 34 – The provision of information to the Commission and the standardisation bodies on new subjects in the national standards programmes (Article 2) 34 – Communication of draft standards to the European and national standardisation bodies and the Commission (Article 3) 37 – Measures for which the Member States are competent (Article 4) 37 – The Member States’ obligation to ensure that European technical harmonisation is not impeded (Article 7) 39 3 Chapter III The procedure applicable to technical regulations 42 – The communication and distribution of information on draft technical regulations and the possible reactions open to the Commission and Member States (Article 8) 42 1. First stage: the obligation to inform 43 a) The Member States’obligations: 43 General rules 43 Specific cases 44 b) The obligations of the Commission 46 2. Second stage: possible reactions open to the Commission and the Member States (comments, detailed opinions, ‘blockage’) 47 The obligation to observe the standstill periods (Article 9) 48 Exceptions to the obligation to notify or observe standstill periods (Article 10) 52 Chapter IV The Standing Committee (Articles 5 and 6) 58 1. General powers 59 2. Specific powers under the procedure applicable to technical regulations 60 3. Specific powers under the standards procedure 60 Chapter V The Application of the Directive 64 – Reports and statistics (Article 11) 64 – Reference to the Directive at the time of adoption of technical regulations (Article 12) 64 – Timetable and application methods 65 Chapter VI Access to information by private individuals and industry and the remedies available to them 68 1. Information published in the Official Journal of the European Union, Series C 68 2. Other sources of information 69 3. The inapplicability of the ‘non notified’technical regulations 69 Conclusion 72 4 Select bibliography 76 Annexes 82 Annex 1 – Contact points at the Commission and in the Member States for the ‘technical regulations’ aspect of the Directive 82 Annex 2 – Contact points for the ‘standards’ aspect of the Directive (Commission, European standardisation bodies, contacts at national level) 84 5 Preface Throughout the past 20 years, the scope of the Directive has been gradually broadened to cover all industrial, agricultural and fishery products. Directive 98/48/EC extended the system to in- clude Information Society services since a need was felt for a In 2000 the European Union launched the Lisbon Strategy – an mechanism for supervising this new and rapidly evolving field, ambitious agenda for reform whose aim was to make the EU while leaving economic operators and the Member States alike the most competitive and dynamic knowledge-based econo- as much freedom as possible to prevent obstacles to technolog- my in the world by 2010. At its half-way mark, in 2005, the Com- ical developments in this sector. mission proposed a renewed approach to this strategy focus- ing on growth and jobs. The Commission identified improving This procedure contributes to the application of the subsidi- the quality of European and national regulation to ensure the arity principle, both through enabling improvements to be smooth functioning of the internal market as a key challenge in made to national legislation and identifying areas where har- this respect. monisation is really necessary. Thus, the decision-making proc- ess can take place at the most appropriate level enabling de- One of the most difficult and important tasks in the manage- centralisation which safeguards the diversity of political, ment of the internal market is preventing the adoption of na- cultural and regional traditions. The Directive has provided an tional technical regulations and standards which create new insight into national regulatory initiatives, has led to the crea- barriers to trade. Twenty years after its entry into force the No- tion of a genuine discussion forum, clearing the way for joint tification Directive (Directive 83/189/EEC, codified by Directive action to strengthen the internal market and has recently con- 98/34/EC) has proved to be a fundamental internal market in- tributed to the establishment of the enlarged internal market strument. of 25 Member States. The mechanism set up by the original Directive 83/189/EEC is Furthermore, this mechanism is a tool of better regulation since based on the agreement of the Member States to inform and it allows the different competent authorities, both at Commu- consult each other and the Commission before they adopt nity and national levels, to prevent problems ex ante thus avoid- technical regulations and to modify their drafts if necessary. By ing costly and controversial infringement proceedings which means of transparency and the exchange of information at the can only be launched ex post. The exchange and gathering of legislative proposal stage, the Member States have agreed to information is also an effective way of ensuring that national prevent the emergence of new obstacles to the single market. best practices become known and are used as a model for oth- er regulatory initiatives. A pre-adoption screening procedure for all draft technical regula- tions and standards relating to products was therefore established Following a 2002 Commission Report which analysed barriers to and gradually expanded. The Commission, the Member States, in- the freedom to provide services and the freedom of establish- dustry and individuals thus have an open window upon technical ment in the Internal Market1, the Commission’s services are work- activities, which enables them to eliminate at source any barriers ing on the possible extension of Directive 98/34 to cover services to the free movement of goods. other than Information Society services. 1 COM(2002) 441 final. 7 Industry, as well as the Commission and the Member States, is involved in the notification procedure. Besides being able to examine legislation in their own countries, enterprises in the Member States have the opportunity of examining legislation proposed by countries to which they export or wish to export or to which they provide or envisage to provide Information Society services. As a consequence, they can plan to adapt their products or services to the new requirements; they can also identify protectionist elements in the drafts and take ac- tion to have them eliminated.