25 EU BARRIERS AS REPORTED BY U.S. SMEs AND OTHERS

Barriers

1. Registration, Evaluation, Authorization and Restriction of Chemicals (REACH): High costs of compliance, responsible EU agency difficult to communicate with, time consuming, required EU representation, required to reveal too much about products, evolving lists of restricted substances, documentation, and other issues. Sectors affected: chemicals, apparel, machinery and equipment, computer and electronics, transportation products, miscellaneous manufacturing.
2. Biocidal Products Regulation: High cost of compliance, applies to each component instead of overall product. Sector affected: Biocidal chemicals.
3. Water Framework Directive: High cost of compliance, applies to each component instead of overall product. Sector affected: Chemicals.
4. Cosmetics Directive: High costs of compliance, separate approvals required for minor product differences (e.g. different colors), required to hire expensive consultants/testing services in EU. Sector affected: Cosmetics.
5. Antidumping/countervailing duty orders: Increase costs. Sectors affected: Biofuel, including bioethanol and biodiesel.
6. High tariffs: Increase costs. Sectors affected: Apparel and processed food.
7. Safety of machine directive: Increase costs, very broad in scope but other directives still apply: Sector affected: Machinery and equipment.
8. Pressure equipment directive and regulations for classifying high-efficiency particulate air (HEPA) filters: Increase costs, difficulty in proving compliance: Sector affected: Machinery and equipment.
9. ATEX (atmospheric explosives) directive: High costs of compliance, different member states certofy equipment according to different standards, incompatability with equivalent U.S. regulations, outside certifications not allowed. Sector affected: Machinery and equipment.
10. Restriction on the Use of Certain Hazardous Substances (RoHS): Increase costs, no equivalent U.S. regulation, lengthy certification process. Sectors affected: Chemicals, machinery and equipment, computers and electronics, transportation products.
11. Waste Electrical and Electronic Equipment Directive (WEEE): High costs of compliance, lengthy certification process. Sectors affected: Machinery and equipment, computer and electronics.
12. Excessive rights of original trademark owner: Block sales of certain original and used equipment with trademarks. Sector affected: Computers and electronics.
13. Automotive parts certification requirements: High costs of compliance, time consuming requirements, requirements vary by region. Sector affected: Transportation products.
14. Lack of harmonization in design standards: Increase costs, standards lack transparency, rules vary by region, prevent SME exports to EU. Sectors affected: Transportation products, misceallaneous manufacturing.
15. EU environmental regulations requiring materials tarcking: Increase costs, time consuming. Sector affected: Transportation products.
16. Standards and technical regulations in aviation: High cost of compliance, European Aviation Safety Agency difficult to communicate with, lengthy and uncertain approval times, some countries require separate certification: Sectors affected: Aircraft, space equipment and parts
17. Obtaining CE mark: High costs of compliance, time consuming, products approval impedes innovation, multiple CE marking requirements for all directives that apply to the product, audit requirement for medical devices too broad, difficulties in finding facility to provide CE certification. Sectors affected: Chemicals, machinery and equipment, computers and electronics, miscellaneous manufacturing.
18. Rules on toys: Differ from those of Internationak Organization for Standardization (ISO), testing rules vary by country. Sector affected: Toys.
19. Sanitary and phytosanitary regulations: Lack science-based approach especially regarding approval of genetically modified traits, increase costs, vary amon EU countries. Sector affected: Agricultural products.
20. Maximum residue levels for pesticides: Increase costs, vary by EU country. Sector affected: Agricultural products.
21. Global Food Safety Initiative (GFSI): Extensive and costly certification, specific certification requirements: Sector affected: Agricultural products.
22. Protected designation of origin (PDOs): Prevent U.S. exports of products with PDOs. Sector affected: Cheese.
23. Lack of mutual recognition of credentials: Increase costs and time or prevents provision of U.S. service. Sectors affected: Healthcare services, engineering services.
24. EU accreditation: High costs of compliance, lack of transparency, hard-to-find regulations. Sector affected: Testing services.
25. Local content quotas, local language dubbing requirements, film piracy: Quotas make more difficult for SMEs to enter certain EU markets; dubbing requirements increase costs; piracy affects independent filmmakers: Sector affected: Audiovisual services.