Prior to exporting, U.S. manufacturers have to consider certification for the EU market. Certification is about conformity assessment 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.
What is the CE Mark?
The CE (an acronym for the French "Conformité Européenne") mark certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety. Manufacturers in the European Union (EU) and abroad must meet CE marking requirements where applicable in order to market their products in Europe.
What does the CE Mark allow me to do?
A manufacturer who has gone through the conformity assessment process, may affix the CE marking to the product. With the CE marking, the product may be marketed throughout the EU. CE marking now provides product access to 27 countries with a population of nearly 500 million.
Which countries require the CE Mark?
| Austria | Belgium | Bulgaria |
| Cyprus | Czech Republic | Denmark |
| Estonia | Finland | France |
| Germany | Greece | Hungary |
| Iceland | Ireland | Italy |
| Latvia | Liechtenstein | Lithuania |
| Luxembourg | Malta | Netherlands |
| Norway | Poland | Portugal |
| Romania | Slovakia | Slovenia |
| Spain | Sweden | Switzerland |
| Turkey | United Kingdom |
How do I know if my product requires the CE Mark?
Unfortunately, there is no comprehensive list of the products that require a CE marking. Therefore, it is the manufacturer's responsibility to determine if a product requires a CE marking. The "New Approach Directives" are documents that contain the legislation issued by the European Commission on the requirements that need to be met and procedures that must be followed in order for a particular product to be CE marked for sales in the EU. In order to determine if your product needs a CE marking, you should look in each directive that you judge as related to your product. A CE marking directives guide is available online by clicking here.
Can I self-certify my product?
Most products covered by New Approach Directives can be self-certified by the manufacturer and do not require the intervention of an EU-authorized testing/certifying company called a notified body. To self-certify, the manufacturer must assess the conformity of the products to the applicable directives and standards. While the use of EU harmonized standards is voluntary in theory, in practice the use of European standards is the best way to meet the requirements of the CE marking directives, especially in the case of the Electromagnetic Compatibility (EMC) and Low Voltage Directives. (The word "harmonized" means that the standards have been approved by all 27 European Union countries). The standards offer specific guidelines and tests to meet safety requirements, while the directives are more general and do not, in most cases, offer detailed specifications on how to meet safety requirements. The Machine Directive, however, does offer more detailed information on how to meet safety requirements than most other CE marking directives. U.S. companies can self-certify to the CE marking requirements of the Machine Directive by meeting the provisions of the directive whether they use European, international or U.S. standards.
While manufacturers can self-certify many products under the New Approach Directives, certain high-risk products cannot be self-certified. These higher risk products require the services of a "notified body" within the European Economic Area (EEA). The EEA consists of the EU plus the European Free Trade Association countries of Iceland, Norway, and Liechtenstein, excluding Switzerland. For information on how to obtain a list of notified bodies, please click here.
Where can I find more information?
More information on CE marking and EU standards is available through the U.S. Commercial Service at the U.S. Mission to the European Union in Brussels, Belgium here.
Please contact a local trade specialist with additional questions.