NAVIGATING THE EU MARKET

1. Susana Getman Commercial Service U.S. Mission to the European Union Brussels, Belgium NAVIGATING THE EU MARKET

2. Overview of Presentation The European Union today Importance of the Transatlantic market Market drivers/opportunities Key EU issues/sectors CS Services, resources and contacts Questions?

3. The European Union = • 27 member states • 500 million consumers

4. Transatlantic Market The EU and the U.S. have the world’s largest bilateral trade relationship. • Worth $4.5 trillion • 1/3 of global trade • 50% of world GDP • 14 million workers employed

5. Transatlantic Market “In 2008, the United States exported over $470 billion worth of goods and services to the EU, more than 5x exports to China ($86 billion).” The combined EU and U.S. economies accounted for 33% of global trade in goods and 42% of global trade in services.

6. Market Drivers/Opportunities Single Market- The EU regulatory environment can be a good thing – comply once for all of the 27 EU markets The EU is promoting its regulatory model – with candidate countries and other 3rd markets Green technology – strict environmental legislation creates market opportunities - energy efficiency, smart grids, e-mobility, green building Public Procurement – opportunities as a result of the Government Procurement Agreement

7. Why the EU Matters 80-90% of commercial law is covered by the EU legislation Sector specific- (electronics, batteries, chemicals, cosmetics, toys, medical devices…) Cross cutting- (procurement, standards, privacy, competition, investment..)

8. Directive: adapted into national law and implemented by member states. Usually with a transition period Regulation: text implemented unchanged by member states. Entry into force usually immediate. Understanding Eurospeak Member States implement

9. Key issues/sectors • Environmental requirements • REACH & CLP, WEEE/RoHS, Energy Efficiency/ Green Building, biocides • Product Safety legislation • CE marking and EN standards • Other market opportunities/issues • Pharmaceuticals, nutritional supplements, cosmetics, medical devices Data Privacy, IPR, ecommerce, services, government procurement…

10. Environmental requirements • Strict environmental requirements to protect health and environment • REACH- Registration, Evaluation, Authorization of Chemicals • CLP- classification, labeling & Packaging of chemicals • WEEE/RoHS- recycling requirements, restrictions of substances in electrical & electronic equipment • Energy efficiency - design requirements

11. REACH • REACH – since 2007 – the biggest piece of EU environmental law. • REACH affects all global supply chains that produce and use chemicals: cars, computers, cosmetics, paints, etc.- must pass information down the supply chain Registration • 30 November 2010 was the deadline for registration of large volume chemicals (1000 tons/yr) • If chemicals are not registered: no access to the EU market (no data, no market) • Next deadlines for registration are in 2013 and 2018 (for lower volume chemicals) – will impact SMEs • Authorization of substances of very high concern

12. Energy Efficiency Directives Eco design and energy efficiency at the design stage Affects 35 energy using consumer products (dishwashers, chillers, DVD players, lights,.... ) Mostly about setting energy use limits Separate legislation for energy efficiency labeling of products and energy performance of buildings February 2011

13. Energy Efficiency/Green BuildingAn opportunity for U.S. Exporters The EU’s 27 member states have begun implementing green building targets Residential and commercial buildings will have to meet these targets A fair percentage of the nearly 500 million consumers will be renovating their homes and upgrading their energy using equipment in the coming years

14. Product Safety Directives: Standards • Use of EU (EN) standards is voluntary, • BUT Conformity assessment, or how a manufacturer meets the requirements spelled out in EU directives, is mandatory • So use of EN (harmonized) standards gives presumption of conformity to EU requirements

15. Product Safety Directives: CE Marking • A mandatory label on the product and/or packaging • A mark of compliance with safety requirements, not a quality mark • Covering +/- 80% of products on the market • An EU-wide “passport” for market access • Self-certifying

16. Low Voltage Simple Pressure Vessels Toys Construction Products Electromagnetic Compatibility Personal Protective Equipment Hot Water Boilers Recreational Crafts Marine Equipment Lifts Pressure Equipment Noise Emission Non-automatic Weighing Scales Machinery Gas Appliances Active Implantable Medical Devices, IVD, Medical Devices High Speed Rail Systems Telecom & Terminal Equipment Packaging & Packaging Waste Civil Explosives Potential Explosive Atmospheres (not exhaustive!) Products requiring CE Marking

17. Chemicals Cosmetics Food Pharmaceuticals Cars and car components Biocides – pesticides Textiles .... General Product Safety Directive: Furniture Child care articles Sports equipment Non electrical tools Books ..... Products NOT requiring CE Marking

18. Other issues/opportunities • Pharmaceuticals • Nutritional Supplements • Cosmetics • Medical devices • Data Privacy • IPR • Ecommerce • Services • Government procurement

19. Pharmaceuticals • Centralized/decentralized market authorization procedures • Revision of Pharmaceutical Legislation • combating counterfeiting • information to patients • pharmacovigilance • Transparency Directive on pricing and reimbursement procedure February 2011

20. Nutritional Supplements Directive on nutritional substances that covers labeling and approved vitamins & minerals. Substances other than vitamins and minerals are still up to member states for approval. Directive on health and nutrition claims Rules on herbal medicinal products Nutrition Labelling rules being updated Novel foods regulation review February 2011

21. Cosmetics • New Regulation • July 2011-July 2013 transition period • Simplified notification to European Commission • Labelling nanomaterials • Responsible person (importer/distributor) • product information file • Registration of ingredients under REACH

22. Exporting to the EU Monitor what’s going on in the EU Pay attention to standards/regulatory requirements Participate in pre-legislative fora discussions Report trade barriers to U.S. Department of Commerce Seek help from Commercial Service

23. Commercial Service to the EU • Analyze the commercial impact of EU legislation and regulation • Counsel companies on EU requirements for exporting • Develop strategies with businesses to secure favorable outcomes & mitigate costs/avoid market access barriers • Identify business opportunities • Advocate on behalf of US business • Outreach to companies through trade fairs • Communicate to US business (mailing lists, webinars, web sites)

24. Our Resources www.buyusa.gov/europeanunion • CSEU’s current 150+ Market Reports include • Smart Grids • WEEE/RoHS • Green Tech • Energy performance of buildings • Nutritional Supplements • Trademark protection in the EU • How to export seafood to the EU • REACH • Government procurement • EU funding • Pharmaceuticals • Medical devices • VAT • Export Controls

25. Commercial Service at USEU • Market Access & Compliance ashley.miller@trade.gov susana.getman@trade.gov • REACH, RoHS, Environment, cosmetics, waterflavie.guerin@trade.gov • Customs & Tariffs, WEEEjohn.fay@trade.gov • Energy, green techVal.huston@trade.gov • ICT, medical devices, privacy • Lucie.Mattera@trade.gov • Standards & Regulations, CE MarkWilliam.Thorn@trade.gov Sylvia.mohr@trade.gov • Government contracts; Defense contracts, EU fundingIsabelle.maelcamp@trade.gov • Pharmaceuticals, Nutritional Supplements, Services, Textiles, IPRsusana.getman@trade.gov • Fisheries/NOAAStephane.vrignaud@trade.gov

26. Questions ?