EU - Country Commercial Guide
Market Challenges

Learn about barriers to market entry and local requirements, i.e., things to be aware of when entering the market for this country.

Last published date: 2021-10-18

The United States and the European Union continue to work towards fair and balanced trade that can grow the transatlantic economy, and Washington and Brussels are engaged in numerous trade and investment workstreams to promote transatlantic commercial opportunities, especially for small and medium-sized enterprises.  These include discussions with a view towards agreement on aircraft subsidies, digital privacy frameworks, digital taxation, and simplified standards and certification procedures for medical devices.

EU legislation generally takes two forms.  Regulations contain mandatory language and are directly and uniformly applicable to all Member States when that regulation comes into effect.  Directives provide a general framework, set regulatory objectives, and must be transposed into national legislation at the Member State-level.  As Member States have different legal systems and regulatory practices, there are differences in how directives are implemented, which complicates compliance for U.S. companies doing business in the European Union. 

The European Union, rather Member States, has competence for legislative harmonization, which it exercises in such areas as the free circulation of goods, services, capital, and in such sectors as agriculture, fisheries, transport, and energy.  Meanwhile, health, tourism, and civil protection are examples of areas where the European Union can legislate only in support of Member States’ initiatives.

While the European Union continues to move in the direction of a single market, the reality remains that American exporters continue to face barriers to entry and challenges with regulations, testing, and standards at the Member State level.  In some industries, such as pharmaceuticals, chemicals, telecommunications, legal services, and government procurement, some of these barriers are more pronounced.

U.S-EU discussions about removing trade irritants or facilitating transatlantic trade are ongoing, including discussions about improving transparency in developing regulatory procedures and standards.  U.S. trade agencies, including the Department of Commerce, continue to work closely with the business community to ensure that the European Union and its Member States comply with their bilateral and multilateral trade obligations, and to minimize market access problems affecting U.S. firms.