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Don’t Let Regulations Trip You Up in the European Union Marketplace

The European Union (EU) is a great market for U.S. goods and services and the U.S. has enjoyed a long and varied history in trading with Europe. The U.S. trade relationship with the EU represents the world’s largest economic relationship and with a market of 500 million consumers, $490 billion of U.S. exports in goods and services have arrived in the EU marketplace.

Even our digital economy plays a significant role in our trade with the EU in which nearly 15 terabits of cross-border data flow per second! In 2014 alone, the U.S. exported a total of $187 billion in digitally deliverable services to Europe. Obviously, the EU has been a great consumer of U.S. goods and services, and because it is a growing marketplace, adding Croatia to its union in 2013 brought the total of EU member countries to 28, it will continue to be a good and growing market for U.S. goods and services.

Even though the U.S. has a very long and mature trading relationship with the EU, it can be a challenging market. The convenience of having 28 countries under common regulations and directives as a seemingly single market seems helpful but could also be the source of compliance issues for U.S. exporters. As the EU is an important market for the U.S., we have a special U.S. Mission to the EU Embassy located in Brussels, Belgium and a large chunk of what our U.S. Commercial Service staff work on, focuses on guiding U.S. companies through EU regulations and directives. As the EU continues to add member countries and work to harmonize their regulations and increase their economic integration, the compliance challenges will continue. To help guide you in the EU marketplace, what follows will be a primer on some of the larger compliance issues that impact most products or services that you need to know when you are readying your product or service for the EU market.

European Standards and CE Marking

Prior to exporting, U.S. manufacturers have to consider certification for the EU market. Certification is about conformity assessment (testing and certification) in order to declare compliance with EU regulatory requirements. For the majority of exported products, compliance is visibly testified by the use of CE marking and use of standards is part of the process.

The CE marking (an acronym for the French "Conformite Europeenne") certifies that a product has met EU health, safety and environmental requirements, which ensure consumer safety. Manufacturers in the EU and abroad must meet CE marking requirements where applicable to market their products in Europe. In order to determine if your product needs a CE marking, a company should review each directive that they judge is related to their product. Our guide to navigating the CE marking process is organized by directives and under each directive, it is explained the route to CE marking certification step-by-step and in one place. Our guide can be found at export.gov/CEmark.

WEEE (Waste Electrical and Electronic Equipment) and RoHS (Restriction of Hazardous Substances)

Companies selling electrical and electronic goods in the EU must conform to the EU legislation for electrical and electronic equipment (EEE), which includes:

• The Waste Electrical and Electronic Equipment Directive (WEEE), which sets out the financial and other responsibilities of EEE producers with regard to the collection and recycling of waste from a broad range of EEE at their end of life.

• The Restriction of Hazardous Substances Directive (RoHS), which bans the use of certain hazardous substances (such as lead, mercury, cadmium, hexavalent chromium and some polybrominated flame retardants) in EEE.

WEEE and RoHS directives are complex pieces of legislation that apply to a similar range of products. Each directive imposes obligations and outcomes that EU member States must achieve. However, each member state may choose the best framework to fulfill its obligations resulting in considerable differences in country to country requirements. Due to this, U.S. exporters need to be mindful that national rules for implementing each Directive will differ from country to country. Which is why we strongly urge U.S. companies to specifically get further information on WEEE and RoHS in the countries where they seek to export. 

REACH (Registration, Evaluation, Authorization and Restrictions of Chemicals)

REACH is the EU regulation governing the manufacture and import of chemical substances and has been in force in all EU member states since June 1, 2007. It also applies in Iceland, Lichtenstein and Norway. In general, REACH requires the registration of chemical substances manufactured or imported into the EU in quantities exceeding 1 metric ton per year. This requirement applies per substance and per manufacturer or importer (as appropriate).

Registration applies to chemical substances as such, in preparations (also called “mixtures”) and, under certain conditions, to articles (finished products) incorporating those substances. REACH assigns the obligation to register on the EU-based manufacturer or EU-based importer. Non-EU-based companies may appoint an “only representative” to manage their registration dossier. Only representatives are commonly referred to by the acronym “OR." U.S. exporters may feel a need to seek professional assistance to ensure compliance with their REACH obligations including the retention of an only representative (OR). Registrations are submitted to the European Chemicals Agency (ECHA) and to help companies determine their REACH obligations and comply with the legislation, they have produced a number of guidance documents that can be found at www.echa.europa.eu/support/guidance.

EUP (Energy-Using Products) and ERP (Energy-Related Products)

Energy-Using Products and Energy-Related Products (EUP and ERP) are regulated in these two designations in regard to eco-design and energy efficiency. Products which use sources of energy, such as televisions, computers, fans and lighting are subject to EU energy efficiency requirements (EUP). Products which indirectly impact energy consumption, such as windows and faucets among others, are also relevant for purposes of efficiency (ERP).  The goal of this regulation is to minimize the use of energy at the design stage and throughout production, transport, packaging, etc. Products in compliance with implementing measures can be easily recognized because they will carry a CE marking. The CE marking will cover relevant product safety as well as energy efficiency requirements if applicable. For more information visit export.gov/europeanunion/energyrelatedproducts.

EU-U.S. and Swiss - U.S. Privacy Shield

The EU-U.S. and Swiss-U.S.. Privacy Shield Frameworks were designed by the U.S. Department of Commerce and the European Commission and Swiss Administration to provide companies on both sides of the Atlantic with a mechanism to comply with data protection requirements when transferring personal data from the European Union and Switzerland to the United States in support of transatlantic commerce. The Privacy Shield was created as a replacement for the Safe Harbour Privacy agreement (2000-2015) between the United States and EU and the overall objectives of the legislation remain the same: Businesses must tell consumers that they are collecting data, what they intend to use it for, to whom it will be disclosed, and to protect the information. For more information on the Privacy Shield, please visit privacyshield.gov.

Digital Single Market (DSM) Initiative

For those companies strictly involved in e-commerce, thanks to the Digital Single Market (DSM) initiative, the EU will have a single market approach to regulations and directives. The DSM is one of the 10 priorities of the European Commission (EC) with the overall objective to bring down barriers, regulatory or otherwise, to unlock online opportunities in Europe, from e-commerce to e-government. By doing so, the EU hopes to join the current 28 fragmented markets and create one borderless digital market with harmonized legislation and rules for the benefit of businesses and consumers alike throughout Europe. Meanwhile, as the DSM is worked towards, if you need help navigating the digital terrain, we have a Digital Attaché in place in Brussels to assist you in growing your global e-commerce channels, gain access to the global online marketplace and navigate EU digital policy and regulatory issues.

If you would like to pursue the EU marketplace but are feeling overwhelmed with the regulations and directives, no worries, the U.S. Commercial Service is in place to assist you. We can help you identify business opportunities, develop a region-wide strategy that suits your objectives, and help guide you through those all-important regulations and directives. You can reach us at 412-644-2800 or visit us at export.gov/Pennsylvania/Pittsburgh.