Supplier’s Declaration of Conformity (SDoC) Experience with respect to electrical and mechanical sectors TBT WORKSHOP Geneva, 21 March 2005 Georg HILPERT European Commission Enterprise Directorate General Mechanical & electrical engineering and radio and telecom terminal equipment industries I have the pleasure to present you the European experiences with the Supplier’s Declaration of Conformity (SDoC) with respect to the electrical and mechanical sectors; The Supplier’s Declaration of Conformity (SDoC) is a well known concept and based on the responsibility of the manufacturer only for the compliance of his product with relevant legal provisions. Introduction: European Commission DG Enterprise and industry LVD directive manager Coordination of European electro technical Standardisation

Free movement of products in Europe Free movement of products in the European internal market Article 28 of the EC treaty “Quantitative restrictions on imports and all measures having equivalent effect shall be prohibited between Member States.” Article 95 of the EC treaty „Technical harmonisation of European legislation taking into account a high level of health, safety, environmental and consumer protection“  New Approach Directives (e.g. LVD, Machinery) Article 28 (ex Article 30)   Quantitative restrictions on imports and all measures having equivalent effect shall be prohibited between Member States. Article 29 (ex Article 34)     ………. Article 30 (ex Article 36)     The provisions of Articles 28 and 29 shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of public morality, public policy or public security; the protection of health and life of humans, animals or plants; the protection of national treasures possessing artistic, historic or archaeological value; or the protection of industrial and commercial property. Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. First “New Approach” Directive in 1987 Since then, more than 20 broad areas of products or risks are covered, including: Machines, Lifts, Pressure equipment, Pleasure boats Medical Devices, in vitro diagnostic equipment Personal Protection Equipment, Toys, RTT equipment Gas appliances, Low Voltage Equipment, EMC Geneva, 21 March 2005 (2)

Elements of the New Approach Directives 1. Conformity assessment and technical documentation 2. Declaration of conformity (SDoC) 3. CE marking ====> Article 28 (ex Article 30)   Quantitative restrictions on imports and all measures having equivalent effect shall be prohibited between Member States. Article 29 (ex Article 34)     ………. Article 30 (ex Article 36)     The provisions of Articles 28 and 29 shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of public morality, public policy or public security; the protection of health and life of humans, animals or plants; the protection of national treasures possessing artistic, historic or archaeological value; or the protection of industrial and commercial property. Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. 4. Market surveillance Geneva, 21 March 2005 (3)

Safety of electrical products 1 The Low Voltage Directive (LVD) 73/23/EEC (adopted on 19th February 1973) Based on article 95 of the EC treaty; purpose is to permit free movement of electrical equipment in Europe “Total harmonisation” and “Total Safety” Directive LVD was adopted in 1973 by the Council and amended in 1993 by the so-called “CE marking Directive”; The LVD regulates the free circulation of electrical appliances in the European Union by setting a high level of protection of persons, domestic animals and property; It is a highly successful Directive and has been in operation for 30 years. It is seen as the first new approach Directive; “Total harmonisation” and “Total Safety” Directive Applies to electrical equipment designed for use with a voltage rating of [50, 1000] V (AC) [75, 1500] V (DC) The market under this directive is around 250 b€. In 2007 the directive will be applicable in the 27 Member States (540 million people) Applies to electrical equipment designed for use with a voltage rating of [50, 1000] V (AC) [75, 1500] V (DC) Geneva, 21 March 2005 (4)

Safety of electrical products 2 The Low Voltage Directive (LVD) 73/23/EEC Guidelines on the application of the Low Voltage Directive - LVD Large system of European electro technical standards based on international standards (~700); There is a legally non-binding guideline on the application of the LVD. It helps ensuring the common understanding, interpretation and a coherent application of the directive; Large system number of European harmonised electro-technical standards based on IEC standards (700); There is a significant decrease of accidents in the last 20 years; Decreasing number of fatal accidents in the last 20 years by electrocution; Geneva, 21 March 2005 (5)

Conformity assessment How to comply with the safety requirements? Manufacturers can apply their own technical specifications or apply harmonised standards PRESUMPTION OF CONFORMITY HARMONISED STANDARDS ARE NOT MANDATORY Geneva, 21 March 2005 (6)

Conformity assessment Internal production control Technical documentation to be kept of 10 years to enable the assessment of the conformity of the electrical equipment to the requirements to the Directive Manufacturing process shall ensure compliance of the manufactured products with the technical documentation Geneva, 21 March 2005 (7)

Conformity assessment Internal production control Procedure whereby the manufacturer ensures and declares that the electrical equipment satisfies the requirements of the Directive => EC declaration of conformity + CE marking Geneva, 21 March 2005 (8)

Supplier’s Declaration of Conformity (SDoC) The manufacturer or his authorised representative established within the Community must draw up an EC declaration of conformity as a part of a conformity assessment procedure provided for in the relevant New Approach directives. => Manufacturer or his authorised representative ensures and declares that his product satisfies the requirements of relevant Directives that apply to it. The manufacturer or his authorised representative established within the Community must draw up an EC declaration of conformity as a part of a conformity assessment procedure provided for in the New Approach directives. => Manufacturer or his authorised representative ensures and declares that his product satisfies the requirements of the relevant Directive that apply to it. Geneva, 21 March 2005 (9)

Supplier’s Declaration of Conformity (SDoC) The EC declaration of conformity contains all relevant information : Reference to relevant directives; Identification of manufacturer or his authorised representative; Product identification; Notified body, if applicable; Reference to harmonised standards or other normative documents; Date of issue of the declaration. The EC declaration of conformity should contain all relevant information to identify the directives according to which it is issued, as well as the manufacturer, his authorised representative, if applicable the notified body, the product, and where appropriate a reference to harmonised standards or other normative documents. Geneva, 21 March 2005 (10)

CE marking The CE marking symbolises the conformity of the product with the applicable European Community requirements imposed on the manufacturer. The CE marking is mandatory and must be affixed before any product subject to it is placed on the market. CE marking must be affixed visibly, legibly and indelibly to the product or to its data plate or where not possible on the packaging. Article 28 (ex Article 30)   Quantitative restrictions on imports and all measures having equivalent effect shall be prohibited between Member States. Article 29 (ex Article 34)     ………. Article 30 (ex Article 36)     The provisions of Articles 28 and 29 shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of public morality, public policy or public security; the protection of health and life of humans, animals or plants; the protection of national treasures possessing artistic, historic or archaeological value; or the protection of industrial and commercial property. Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. Geneva, 21 March 2005 (11)

Electrical fatal accidents in the USA and Germany Low Voltage Directive Manufacturer‘s declaration of conformity Sources: National Center for Health Statistics (USA), VDE (Germany), Biegelmeier, Gottfried, Liber Amicorum - Liber Inimicis, Nowak, Kurt, 81 tödliche Stromunfälle 1998, de 8/2000 Geneva, 21 March 2005 (12)

Conformity procedure Electrical products (Low Voltage Directive 73/23/EEC) => High risk products but only Manufacturer´s declaration (self declaration), no mandatory third party testing Machinery products (Machinery Directive 98/37/EC) => Medium and high risk products: a) Manufacturer´s declaration (self declaration), no mandatory third party testing b) Mandatory third party intervention for Machines listed in Annex IV of the Machinery Directive. Geneva, 21 March 2005 (13)

Conformity Assessment Self-declaration or manufacturer declaration (e.g. LVD) The CA Modules EC Type Examination (e.g. Machinery Directive) SDoC & During the Conformity Assessment manufacturers demonstrate product conformity against the provisions of the relevant directive. Conformity assessment modules relate to the type of products and hazards involved. Total Quality Assurance Geneva, 21 March 2005 (14)

Market surveillance Member States are responsible for Market Surveillance If restrictions to free movement: ==> Safeguard clause notification ! 1. Market surveillance - guarantees equal protection for citizens and a level playing field for enterprises - is a national responsibility - is carried out by government officials in the market place 2. The goal is a uniformly high level of enforcement of Internal Market legislation 3. Necessity to collaborate between administrations to ensure uniform enforcement (ADCO) Geneva, 21 March 2005 (15)

Manufacturer´s Liability European Liability Directive 1999/34/EC Enforced by the member states Certification bodies do not carry any liability Manufacturers a l w a y s liable ! Regulations and jurisdiction in all other countries Additional national regulations The manufacturer is liable for the products he puts on the market This reflects the legal fact – valid in almost all cultural areas – that it is always the manufacturer (or importer if the manufacturer is abroad) who is legally liable for his products. Certificates, especially quality management certificates, are dealt with neither in commercial nor in contractual law. So they have no direct relevance in contractual situations with respect to liability. In Europe this principle is legally defined by the Product Liability Directive which is enforced by the Member States. This harmonized European liability legislation, giving the manufacturer the liability independent of a fault stands beside the national legislations that already gave the manufacturer the liability in case of faulty products. Geneva, 21 March 2005 (16)

Comparison of Conformity Assessment procedures CA with self certification CA with third party involvement Criteria Conformity Assessment First Party Third Party Certification Market access faster slower Price lower higher Market- surveillance necessary Let me come to the end. I want to talk about and to all nations claiming for mandatory product certification. The trust system in the European Union demonstrates the manufacturers responsibility. For products of normal risk there is no demand for mandatory third party involvement while higher risk products like medical devices or pressure vessels by understandable reasons need third party testing and safety verification. For the normal products, the choice of how to do the conformity assessment is given to the manufacturer. He has the choice to base the declaration on his own tests or to involve an independent third party. The market access is fast, as no other parties have to be involved and prices are not influenced by extra testing costs or conformity assessment dues. Mandatory testing procedures for example in some Eastern Europe countries or China are known to be time intensive, market access is slower, due do mandatory testing periods in dictated testing institutions and product prices are higher, as testing and certification is not done for free. This costs have to be added to the market prices in this countries. In some countries mandatory certification seems to be more a money making machine; but it is definitely a barrier to trade and not in line with the technical barriers to trade agreement of the WTO. Market surveillance is required in both systems, as tricky manufacturers, only interested in quick earnings may manipulate declarations of conformity as easy as mandatory markings or certificates. But in both systems, the responsibility for faulty products and the damages caused by them stays with the manufacturer or supplier. As already said, no chance for earning profits without taking the responsibility. Ultimate Responsibility Manufacturer or Supplier Manufacturer or Supplier Geneva, 21 March 2005 (17)

Thank you for attention Geneva, 21 March 2005 (18)

Where to find more information Electrical safety: http://europa.eu.int/comm/enterprise/electr_equipment/lv/index.htm Email: lvd@cec.eu.int, georg.hilpert@cec.eu.int Blue Guide: http://europa.eu.int/comm/enterprise/newapproach/legislation/guide/legislation.htm Euro Info Centres http://europa.eu.int/comm/enterprise/networks/eic/eic.html Geneva, 21 March 2005 (19)