1. Standardization system in the European Union Werner STERK Federal Ministry of Economics and Technology Unit “Standardization, Conformity Assessment, Metrology” Germany IFAN Workshop: Application of standards in China and beyond Beijing, 25-26 October 2006

2. 2 1. Standardization in Europe 2. Linking regulation with standards in the EU 3. WTO and International standardization

3. 3 Years ago: Different national standards and regulations complicated movement of goods within the EU.

4. 4 Today: Most DIN Standards are elaborated at European or international level (ISO/IEC)

5. 5 European standardization:  The European standards organizations are CEN, CENELEC (electrotechnical sector), ETSI (telecommunication)  Only one national standards body per country is member of the European standards organizations  National standards bodies agreed to transpose each ratified European standard (EN) into a national standard (e.g. DIN EN, BS EN, NF EN,…) and  Systematic withdrawal of conflicting national standards Result: Coherent and common standards in the 25 member states of the European Union (EU) and the 3 countries of the European Free Trade Association (EFTA)

6. 6 1. Standardization in Europe 2. Linking regulation with standards in the EU 3. WTO and International standardization

7. 7 The New Approach: Example for a standards receptive legal framework  Free trade in products within the EU required a systematic approach for regulation, standardization and certification  EC Directives contain only essential requirements for products (e.g. safety objectives)  Specified by harmonized European standards, ratified by recognized European standards organizations (CEN, CENELEC, ETSI)

8. 8 Legally binding requirements EC Directives e.g. for Machinery, Medical devices, Electrotechnical equipment… National transposition without changes (full legal harmonization) Specified by voluntary European standards (EN) of CEN/CENELEC/ETSI Identical transposition of ENs into national standards Withdrawal of conflicting national standards Voluntary standards

9. 9 Sectors under New Approach legislation:  Electrical equipment  Machinery  Pressure equipment  Toys  Medical devices  Lifts  Personal protective equipment  … Trade volume: 1500 billion Euro per year!

10. 10 Role of European Standards in New Approach legislation  Application of Harmonized European Standards (EN) remains voluntary  Harmonized EN provide a presumption of conformity with the essential requirements of the EC Directives, if their reference (number, title,…) has been published in the Official Journal of the EU  How to get information on EC Directives, European Standards listed in the Official Journal, Standards sales points:

11. www.newapproach.org

12. 12 1. Standardization in Europe 2. Linking regulation with standards in the EU 3. WTO and International standardization

13. 13 WTO and International standardization  WTO members agreed to base their technical regulation on International standards in order to reduce technical barriers to trade (WTO/TBT Agreement)  WTO Standards Code defines criteria for International standardization such as: - no national standards as barriers to trade - adoption of International standards - voluntary application of standards - participation of national delegations - no duplication of work - establishing consensus at national level - coherence of standards - publication of work programmes - public enquiry (min. 2 months for comments) - fair discussion of comments received

14. 14 International standardization policy Systematic European approach to elaborate standards at international level first: Vienna and Dresden Agreements: Bridges between ISO/CEN and IEC/CENELEC (non electrical sector: 55% EN related to ISO; electrical sector: 85% EN related to IEC)

15. 15 International standardization policy (2)  Regulated areas: Policy is to allow the adoption of International standards elaborated by recognized International standards organizations (ISO, IEC, ITU) as EN as far as possible (“global relevance”)  Cooperation and exchange of information between regulators and standards organizations necessary

16. 16  European Commission/China; European standardization expert Mr. Klaus Ziegler in China (EU representation in Beijing)  Sino-German Economic Committee: Working Group Standardization established in 2006 (2 meetings in July and December)  Cooperation Agreement between SAC and DIN signed on 10 April 2006 Cooperation with China

17. 17 Vision “one standard, one test, accepted everywhere”  Overcome legal differences by harmonizing technical requirements to facilitate global trade  International standards, transposed into national standards without changes and withdrawal of conflicting national standards, facilitate technical harmonization at global level  Linking technical regulation to standardization on the basis of International standards in a coordinated and transparent way

18. 18 Contacts:  Werner STERK German Ministry of Economics and Technology Tel +49 228 615 2357 werner.sterk@bmwi.bund.de  Klaus ZIEGLER European Standardization Representative for China Delegation of the European Commission 15, Dongzhimenwai Dajie, Sanlitun Beijing, 100600 – CHINA Tel +86 10 8454 8166 / +86 10 8454 8000 Fax +86 10 8454 8011 klaus.ziegler@ec.europa.eu THANK YOU FOR YOUR ATTENTION