Standardization system in the European Union

Werner STERKFederal Ministry of Economics and TechnologyUnit “Standardization, Conformity Assessment, Metrology”Germany

IFAN Workshop: Application of standards in China and beyondBeijing, 25-26 October 2006

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1. Standardization in Europe2. Linking regulation with standards in the EU3. WTO and International standardization

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Years ago:

Different national standards and regulations complicated movement of goods within the EU.

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

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1986 1988 1990 1992 1994 1996 1998 2000 2002 2004

DIN Standards elaborated at EN/ISO/IEC level

DIN Standards elaborated at national level

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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)

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1. Standardization in Europe2. Linking regulation with standards in the EU3. WTO and International standardization

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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)

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Legally binding requirements

EC Directives e.g. for Machinery, Medical devices, Electrotechnical equipment…

National transposition without changes

(full legal harmonization)

Specified by voluntaryEuropean standards (EN)

of CEN/CENELEC/ETSI

Identical transposition of ENs into national standardsWithdrawal of conflicting national standards

Voluntary standards

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Sectors under New Approach legislation: Electrical equipment Machinery Pressure equipment Toys Medical devices Lifts Personal protective equipment …

Trade volume: 1500 billion Euro per year!

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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:

www.newapproach.org

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1. Standardization in Europe2. Linking regulation with standards in the EU3. WTO and International standardization

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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

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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)

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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

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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

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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

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Contacts:

Werner STERKGerman Ministry of Economics and Technology Tel +49 228 615 2357werner.sterk@bmwi.bund.de

Klaus ZIEGLEREuropean Standardization Representative for ChinaDelegation of the European Commission15, Dongzhimenwai Dajie, SanlitunBeijing, 100600 – CHINA Tel +86 10 8454 8166 / +86 10 8454 8000Fax +86 10 8454 8011klaus.ziegler@ec.europa.eu

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