General principles of the New Approach legislation Workshop on the Pressure Equipment Directive, Riga 27-28.11.2003 GORAN LINDHOLM, Principal Administrator Directorate General for Enterprise European Commission General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

FREE MOVEMENT OF GOODS IN THE EU Contents Background The Old Approach The New and the Global Approaches The Voluntary sector Details about the New and the Global approaches Conclusions General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

1 THE EU APPROACHES General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

THE SINGLE GOAL OF THE EU APPROACH IS An Internal Market with free movement of goods ….. the resulting structures are a consequence of this effort. General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

FREE MOVEMENT OF GOODS GOAL INSTRUMENTS Remove technical barriers to internal EU trade, deriving from national technical regulations, standards and test and certification procedures INSTRUMENTS MUTUAL RECOGNITION TECHNICAL HARMONIZATION General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

MUTUAL RECOGNITION Treaty of Rome Art. 28-29/EC: take appropriate measures to ensure Internal market Treaty of Rome: Art. 30/EC: avoid unjustified measures restricting the circulation of goods General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

TECHNICAL HARMONIZATION 1983: Directive 98/34/EC on information procedure for technical standards and regulations. Council Resolution of 7 May 1985 on “New Approach” Council Resolution of 21 Dec 1989 on “Global Approach” Council Decision 93/465/EEC on the “modules” for conformity assessment General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

THE EU APPROACHES The Old “Approach” The New and the Global Approaches The Voluntary sector General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

2 THE OLD “APPROACH” General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

THE OLD “APPROACH” Products covered by EU legislation with mandatory detailed technical specifications The legislation may refer to mandatory use of European standards (that are nationally adopted) The legislation usually needs frequent update to adapt to technical progress Usually control by public authorities prior to placing products on the market Voluntary markings may be used General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

3. THE NEW AND THE GLOBAL APPROACHES General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

THE TWO PARTS OF THE NEW AND THE GLOBAL APPROACHES PRE-MARKET ASSESSMENT Products placed on the market must fulfil essential requirements. The manufacturer assures this by affixing the CE marking on the product POST-MARKET CONTROL Member States must control that the products on their market are in compliance with the essential requirements. This is done by national authorities using market surveillance General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

THE NEW AND GLOBAL APPROACHES’ BASIC FEATURES Complementary instruments designed to: cover wide fields of product or risk in one piece of legislation impose generic essential requirements which do not get out of date limit Government intervention to what is essential General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

4. THE VOLUNTARY FIELD General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

THE VOLUNTARY FIELD No EU legislation, regulated nationally European standards may voluntarily be developed within the European standards bodies. National standards are allowed, but if European standards exist, competing national standards are not allowed If products fulfil the national regulations they may usually move freely in the internal market Voluntary marks may be used General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

5. DETAILS ABOUT THE NEW AND THE GLOBAL APPROACHES - pre market assessment General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

ELEMENTS OF THE NEW APPROACH Essential requirements in directives (presently 22 New Approach directives) Harmonised standards Conformity assessment CE marking General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

Standards are voluntary…. Harmonised European standards => mandated by the Commission and giving presumption of conformity with essential requirements … but remain voluntary! CEN / CENELEC / ETSI elaborate European Standards General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

…and standardisation is independent Standards are not defined by public authorities Standards are adopted by a transparent consensus procedure The standardisation bodies cover a very broad range of interests including the industry’s … and are therefore widely recognised General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

GLOBAL APPROACH TO CONFORMITY ASSESSMENT Manufacturer (or his authorised representative) is responsible for conformity Shall use defined procedures (“modules”) Must in many modules be aided by Notified bodies Is free to choose any suitable Notified body General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

CONFORMITY ASSESSMENT - KEY ELEMENTS Modules Notified bodies Quality assurance Technical file EC declaration of conformity CE marking => free movement of goods in Single Market General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

1. Modules... The Global Approach establishes eight basic modules to cover different situations Each Directive specifies which modules can be used There are modules for both the product’s design and production phase Most modules require use of notified bodies General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

…the basic Modules Internal control of production (design&production) EC type examination (design) (notified body) Conformity to type (production) Production quality assurance (prod.) (notified body) Product quality assurance (production) (notified body) Product verification (production) (notified body) Unit verification (design&production) (notified body) Full quality assurance (design&prod.) (notified body) General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

2. Notified Bodies... 1100+ Independent third parties Notified by Member States, who ensure their competence Co-operation …. and competition General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

...Notified Bodies’ qualifications... Supported by: Accreditation EN 45000 series of standards (usually identical to ISO guides / standards) Sector criteria / technical competence General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

...Notified Bodies’ responsibilities Provide conformity assessment services on the conditions set out in Directives Operate impartially, independent of clients Provide relevant information to notifying authority, market surveillance authorities, other notified bodies Ensure confidentiality of information as necessary Take part or be represented in European standardisation General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

3. Quality Assurance Three modules require quality assurance ISO 9000 offers one solution, but is not mandatory! General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

4. Technical File (technical documentation) Prepared by manufacturer Kept by him Provides information on the design, manufacture and operation of the product The detailed requirements are defined in each directive Must be available to authorities and Notified bodies General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

5. EC Declaration of Conformity Drawn up and signed by manufacturer (or his authorised representative) on own responsibility Contains all relevant information, as defined in each Directive The information must include the product, the manufacturer, applicable directives and standards, assurance of conformity and the notified body, if used General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

6. CE marking Affixed by manufacturer (or his authorised representative) on own responsibility meaning that: the product meets the legal requirements it is presumed to be marketable The CE mark is not a mark of origin – and not a quality mark! General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

THE MANUFACTURER’S RESPONSIBILITIES UNDER THE NEW AND GLOBAL APPROACH ARE TO... Ensure compliance with essential requirements of Directive(s) Use appropriate assessment modules Choose appropriate notified body Establish the technical file Draw up the EU declaration of conformity Affix the CE marking as the final sign of conformity General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

…AND HIS ADVANTAGES OF THESE APPROACHES ARE Only one set of technical regulations and marking requirements that gives fast-track access to the whole EU market Availability of a coherent set of European standards, which do not compete with each other Same rules for importers and EU manufacturers General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

5. DETAILS ABOUT THE NEW AND THE GLOBAL APPROACHES - post market control General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

MARKET SURVEILLANCE... Market surveillance guarantees equal protection for citizens and a level playing field for enterprises the goal is a uniformly high level of enforcement of Internal Market legislation General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

...MARKET SURVEILLANCE... Market surveillance is a national responsibility It is carried out by government officials in the market place Few explicit requirements in the Directives but implicit requirements in the Treaties Rapex communication system between the Commission and Member States General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

...MARKET SURVEILLANCE Different national structures local authorities, state or autonomous region or national Different national approaches systematic sampling, annual campaigns, targeting purchasers General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

6. CONCLUSIONS General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

Development… The New and Global Approach is working properly and has proven to be successful Improvements and expansions take place General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

…Development Example of activity areas: Co-operation in market surveillance between Member States Designation and notification of Notified bodies Understanding of the CE marking The use of the New and Global approach principles in other legislation General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

International extension of the New and Global Approach European Economic Area PECAs under the Europe Agreements Mutual Recognition Agreements (MRAs) Other recognition/cooperation forms (toolbox) General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

This approach completes the Single Market by enhancing safety and performance of products offering a flexible technology-neutral legal environment offering alternatives and reducing undue burdens for enterprises …the resulted successful structures and free movement of goods are a consequence of this effort General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm

For more information Guide to the implementation of directives based on the New Approach and the Global Approach (11 EU languages) on Internet (http//europa.eu.int/comm/enterprise/newapproach/index.htm) New and Global Approach CD-ROM General Principles of the New Approach legislation, Riga 27.11.2003 - Göran Lindholm