1. ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission Anna Solé Mena Policy Officer - European Commission DG Enterprise and Industry

2. ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission Approval Schemes for Electrical Equipment in the EU EU-Taiwan high voltage equipment management forum 25/26 March 2014 Anna Solé Mena DG Enterprise and Industry European Commission

3. ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission Overlap Products between 600-1000(1500) V For this reason we will provide information on EU Low Voltage Directive EU Low Voltage Directive (2006/95/EC) Taiwanese Directive 401 Over 600 V Electrical Equipment: High and Low Voltage

4. ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission Electrical Equipment High Voltage For equipment of higher voltage than 1000 V (AC) and 1500 V (DC) :  No EU-wide Directive  Ensuring safety is the responsibility of the manufacters themselves.  EU Member States can take corrective actions and punishments if necessary, such as prohibiting placing the products on the market  We will hear the examples of the Netherlands and Germany, but all MS proceed similarly.

5. ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission EU Low voltage Directive MANDATORY: Products placed on the market must fulfil safety objectives (defined by Directive) VOLUNTARY: Harmonised standards: Presumption of conformity Conformity Assessment Procedures must be followed. The manufacturer must :  establish Technical Documentation proving the product's safety and keep it at the disposal of the authorities  issue a Declaration of Conformity  affix the CE marking on the product

6. ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission CONFORMITY ASSESSMENT FOR ELECTRICAL EQUIPMENT Internal control of production :  At all times manufacturers must ensure that only compliant products reach the market The Government role is to police the market (market surveillance): we achieved a very high safety record

7. ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission Safety objectives of the LVD Article 2  1. The Member States shall take all appropriate measures to ensure that electrical equipment may be placed on the market only if, having been constructed in accordance with good engineering practice in safety matters in force in the Community, it does not endanger the safety of persons, domestic animals or property when properly installed and maintained and used in applications for which it was made.  2. The principal elements of the safety objectives referred to in paragraph 1 are listed in Annex I.

8. ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission Safety objectives of the LVD 1. General conditions a)The essential characteristics… shall be marked on the equipment b)The manufacturers or brand name or trade mark should be clearly printed on the electrical equipment c)ensure that it can be safely and properly assembled and connected. d)… protection against the hazards is assured providing that the equipment is used in applications for which it was made and is adequately maintained. 2. Protection against hazards arising from the electrical equipment a)protection against danger of physical injury or other harm which might be caused by electrical contact direct or indirect; b)that temperatures, arcs or radiation which would cause a danger, are not produced; c)protection non-electrical dangers caused by the electrical equipment which are revealed by experience; d)insulation must be suitable for foreseeable conditions. 3. Protection against hazards which may be caused by external influences a)electrical equipment meets the expected mechanical requirements b)electrical equipment shall be resistant to non-mechanical influences in expected environmental conditions c)protection in foreseeable conditions of overload.

9. ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission Presumption of Conformity-Harmonised Standards Harmonised European standards elaborated by CEN / CENELEC / ETSI Publication of reference in the Official Journal ! Voluntary application by manufacturers: presumption of conformity 75% of European Harmonised Standards IDENTICAL to international standards (ISO/IEC).

10. ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission Technical file and DoC Technical file must contain trustworthy evidence of compliance (design, tests done, etc.) DoC:  Drawn up and signed by the manufacturer (or his authorised representative) on own responsibility  The information must include the product, the manufacturer, applicable directives, applied harmonized standards, assurance of conformity and, - if used - the Conformity Assessment Body Notified to COM and MS

11. ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission CE Marking Affixed visibly, legibly and indelibly on the own responsibility by manufacturer or his authorised representative Means that the manufacturer DECLARES to meet the legal requirements and to be marketable It is not a quality mark or a mark of origin

12. ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission Enforcement-Post Market Control EU Market Surveillance Framework (Regulation 765/2008) National Responsibility (principle of subsidiarity) to organise and carry out surveillance and organise cooperation Carried out by Government Officials: Market Surveillance Authorities – can perform controls, withdraw dangerous products… EU level: coordination, uniform enforcement, risk assessment methodologies, international cooperation…  Rapid exchange of information on products posing a risk to health and safety

13. ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission THIRD COUNTRIES Extension of EU Internal Market:  EEA States (Iceland, Norway, Liechtenstein)  Customs Union with Turkey (equivalent legislation) Mutual Recognition Agreements:  Switzerland – equivalent legislation  US – 2000 – Electrical Safety Annex  Japan – 2002 – Electrical Products

14. ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission Conclusion We oblige manufacturers to ensure that products are totally safe They must at all times be able to proof that the products are safe and keep technical documentation at the disposal of the authorities While the EU encourages the use of international standards, ISO/IEC 17025 only sets general requirements for the competence of testing and calibration laboratories, while ISO/IEC 9001 refers to quality management. They do not aim directly at the safety of products. In the EU we do not require testing/third party certification in government recognised laboratories The Government's role is to police the market: we achieve a very high safety record.

15. ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL European Commission Thank you for your attention