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Standards Issues and Trends in the European Union: 

Standards Issues and Trends in the European Union Gwen Lyle Standards Attaché U.S. Mission to the European Union

Format of the Presentation: 

Format of the Presentation What can we do for you? International Standards Trade barriers or trade hurdles? Comparison EU-US standards Participating in the EU process The View from Brussels EU Issues Standards trends and initiatives

Why Are Standards Important to You?: 

Why Are Standards Important to You? Principle non-tariff barrier in the world Affect more than 80 percent of world trade

Standards AttachésStandards Specialists: 

Standards Attachés Standards Specialists

What can we do for you?: 

What can we do for you?

Market Research: 

Market Research

Market Research: 

Market Research Data Privacy: EU Data Retention Regulation EU Rules Banning Spam Transferring Customer and Employee data from the EU to the U.S. Telecommunications How the EU is Regulating Voice over Internet Protocol (VoIP) EU Spectrum Decision Boosts Wireless Internet Access Market Environment/Energy: EU Funds for the environment The EU Eco-label Energy Using Products (EuP) Consumer Goods/Medical: The Cosmetics directive Medical Device Legislation in the EU WEEE/RoHS Update The new EU chemicals legislation: REACH EU Franchising EU Food Contact Plastics EU Pet Food Regulations Regulation of the Food Supplements EU Packaging and Packaging Waste Language Requirements for Product Labels Fisheries Animal Health Certification How to Export Seafood

Market Research: 

Market Research EU Funding and Government Procurement: IPA Funds for future EU Member States The European Investment Bank   Intellectual Property Rights: Protecting Designs in the EU EU Trademark Protection Patent Protection in the EU Transportation: Trans-European Transport Projects End-of-life-vehicles Security and Defense: The European Defence Agency European Aviation Safety Security and Safety Opportunities in the EU Selling U.S. Products and Services in the EU: Proposal for an Origin Marking Scheme for Imported Products Metric Only Requirements for the EU begin 2010 Entry into the EU Legal Services Market Prospects for non-EU Lawyers Commercial Agents in the EU

Market Research: 

Market Research Standards/Product Safety: Standards and Product Certification in the EU The New Machine Directive Better Energy Performance of Buildings in the EU The EU's Directive on Construction Products Changes in EU Legislation for EMC The General Product Safety Directive

Advocacy with the Commission:Case Study: 

Advocacy with the Commission: Case Study

Advocacy with SDOs:Case Study: 

Advocacy with SDOs: Case Study

Voluntary Standard: 

Voluntary Standard Document approved by a recognized body, that provides, for common and repeated use, rules guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory

Technical Regulation: 

Technical Regulation Document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labeling requirements as they apply to a product, process or production method.

International Standardization: 

International Standardization

Wouldn’t it be nice?: 

Wouldn’t it be nice?

International Standards: 

International Standards Are to be used as a basis unless “ineffective or inappropriate”.

U.S. and Internationally Accepted Standardization Principles: 

U.S. and Internationally Accepted Standardization Principles Transparency Openness Due Process Consensus

The benefits of standards: 

The benefits of standards Commercial Communication Technology Diffusion Production Efficiency Enhanced Competition Compatibility Process Management Public Welfare

Standards as Market Access Barriers: 

Standards as Market Access Barriers

 Technical Barrier to Trade (TBT) Code of Good Practice National treatmentConsistent with relevant international standardsStates product requirements in terms of performance rather than design or descriptionDoes not create unnecessary obstacles to trade: 

Technical Barrier to Trade (TBT) Code of Good Practice National treatment Consistent with relevant international standards States product requirements in terms of performance rather than design or description Does not create unnecessary obstacles to trade

Unnecessary Obstacles to Trade: 

Unnecessary Obstacles to Trade Measures may not be more trade restrictive than necessary to achieve a government’s legitimate objective which can include National security Protection of human health and safety, or animal, plant life and health Environmental protection Prevention of deceptive practices

Design vs. performance based standards A good argument: 

Design vs. performance based standards A good argument

Comparison between the Systems: 

Comparison between the Systems

EU Member States: 

EU Member States Austria Belgium Cyprus Czech republic Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta The Netherlands Poland Portugal Slovakia Slovenia Spain Sweden United kingdom Romania Bulgaria

Competing systems: 

Competing systems

Slide31: 

American standards are being developed by more than 450 standards developing organizations (SDOs), with the twenty largest of these organizations producing approximately 80% of the standards, and at least 150 consortia outside the formal standards development process

Typical Standards Developing Organizations (SDO): 

Typical Standards Developing Organizations (SDO) Private Sector Scientific and Professional Societies Trade Associations Standards Developing Member Organizations Federal Government Department of Defense General Services Administration Other federal agencies

Slide33: 

A Private- and Public-Sector Partnership Since 1918 ANSI is not a government agency or a standards developer. Academia Individuals Government Manufacturing Trade Associations A Federation of members representing . . . Professional Societies Service Organizations Standards Developers Consumer and Labor Interests and many more

There is no single U.S. government agency that has control over standards: 

There is no single U.S. government agency that has control over standards NTTAA – National Technology Transfer and Advancement Act (1996) Encourages Federal Agencies to first rely upon voluntary consensus standards – and if not, justify to Congress why not

The European Union: 

The European Union Three Standards Developing Organizations

EFTA Countries: 

EFTA Countries Iceland Liechtenstein Norway Switzerland

The European Committee for Electrotechnical Standardization: 

The European Committee for Electrotechnical Standardization

CENELECAffiliates and Cooperating Organizations: 

CENELEC Affiliates and Cooperating Organizations Cooperating Organizations 36 European industrial and social Federations which contribute to and advise in their field of expertise Affiliates Albania Croatia Tunisia Turkey Serbia Ukraine Bosnia-Herzegovina Former Yugoslav Republic of Macedonia   

The European Telecommunications Standards Institute: 

The European Telecommunications Standards Institute

ICT industry is different: 

ICT industry is different

The European Committee for Standardization: 

The European Committee for Standardization

CEN Affiliates and Partner Organizations: 

CEN Affiliates and Partner Organizations Partners Armenia Australia Bosnia and Herzegovina Egypt Russian Federation Serbia Tunisia Ukraine   Affiliates Albania Croatia Turkey The Former Yugoslav Republic of Macedonia

Vienna and Dresden Agreements: 

Vienna and Dresden Agreements

The EU has a deliberate and aggressive plan to export their regulatory and legislative systems to enhance international trade for EU companies: 

The EU has a deliberate and aggressive plan to export their regulatory and legislative systems to enhance international trade for EU companies

How standards are developed: 

How standards are developed

Technical Committee meeting: 

Technical Committee meeting

Mirror Committees: 

Mirror Committees

New Approach Legislation = CE Mark : 

New Approach Legislation = CE Mark A mandatory label on the product or packaging

Demonstrating Conformitywith European Standards (EN)gives a “presumption of conformity”: 

Demonstrating Conformity with European Standards (EN) gives a “presumption of conformity”

Demonstrating Conformity with non-European standards: 

Demonstrating Conformity with non-European standards

The view from Brussels: 

The view from Brussels

The view from Brussels: 

The view from Brussels

DIFFERENCES IN REGULATORY PHILOSOPHY : 

DIFFERENCES IN REGULATORY PHILOSOPHY The market place can operate without intervention because Legal liability of seller if product defective or hazardous Consumer access to information about product quality Size of market and extent of competition U.S. laws and regulations on truth in labeling and advertising - with legal penalties for false information

DIFFERENCES IN REGULATORY PHILOSOPHY : 

DIFFERENCES IN REGULATORY PHILOSOPHY Tendency to Over-regulate Emphasis on social and environmental aspects over business aspects “Better Regulation” designed to reduce red tape, simplify and reduce regulation - alternatives to legislation include the promotion of European standards as technical support to European legislation

Basis of Legislation: 

Basis of Legislation

Old Approach-New Approach: 

Old Approach-New Approach Old Approach New Approach specifies technical specifies details in the essential legislation safety, health and environmental requirements

New Approach Directives : 

New Approach Directives Machinery Gas Appliances Simple Pressure Vessels Pressure Equipment Toys Construction Products Personal Protective Equipment Hot Water Boilers Recreational Crafts Marine Equipment High Speed Rail Systems Lifts and Cableways Measuring Instruments Non-automatic Weighing Instruments Active Implantable Medical Devices, IVD, Medical Devices Radio Telecom & Terminal Equipment (RTTE) Civil Explosives Potential Explosive Atmospheres Electromagnetic Compatibility Energy Using Products (EuP)

Directives which are based on certain elements of the New Approach : 

Directives which are based on certain elements of the New Approach Low Voltage Packaging & Packaging Waste Noise Emission Energy Efficiency Requirements for Household Refrigerators Transportable Pressure Equipment Energy Efficiency Requirements for Ballasts for Florescent Lighting Interoperability of the Trans-European Conventional Rail system

European Union Issues: 

European Union Issues

The Metric Directive: 

The Metric Directive

The Bottom Line: 

The Bottom Line Beginning January 1, 2010 the European Union Council Directive 80/181/EEC (Metric Directive) will allow the use of only metric units Leaving U.S. customary units on labels, packaging, advertising, catalogs, technical manuals, and user instructions will be illegal in the European Union

Commission Consultation: 

Commission Consultation It is hoped that the Commission will propose a change to be voted by the Parliament and the Council as a result of the consultation which closed this February

Eco-design Requirements for Energy-Using Products (EuP) : 

Eco-design Requirements for Energy-Using Products (EuP)

Energy Using Products (EuP)first 14 “implementing measures”: 

Energy Using Products (EuP) first 14 “implementing measures” Battery chargers and external power supplies (complete) Public street lighting (due Spring 2007) Personal Computers (desktops & laptops) and computer monitors (due Spring 2007) Consumer electronics: televisions (due Spring 2007) Office lighting (due Spring 2007) Standby and off-mode losses of EuPs (due Spring 2007) Boilers and combi-boilers (gas/oil/electric) (due Fall 2007) Water heaters (gas/oil/electric) (due Fall 2007) Imaging equipment: copiers, faxes, printers, scanners, etc (due Fall 2007) Standby and off-mode losses (due Spring 2007) Residential room conditioning appliances including ventilation) (due Fall 2007) Electric motors 1-150 kW, water pumps (commercial buildings, drinking water, food, agriculture), circulators in buildings, ventilation fans (nonresidential) (due Fall 2007) Commercial refrigerators and freezers, including chillers, display cabinets and vending machines (due late Spring 2007) Domestic dishwashers and washing machines (due late Spring 2007)

Energy Using Products (EuP)next 5 “implementing measures” the following studies will be launched in 2007: 

Energy Using Products (EuP) next 5 “implementing measures” the following studies will be launched in 2007 Solid fuel small combustion installations Laundry driers Vacuum cleaners Set-top boxes Domestic lighting   Links to all the studies can be found through the EU Commission Directorate General for Energy and Transportation website

U.S. – EU Initiatives: 

U.S. – EU Initiatives

Trends in European standardization: 

Trends in European standardization

You find EU standards confusing?: 

You find EU standards confusing?

Don’t worry – call me!(or email me): 

Don’t worry – call me! (or email me)

Slide77: 

Gwen.Lyle@mail.doc.gov www.buyusa.gov/europeanunion

THE END: 

THE END