Seven Steps to Qualifying For CE Marking in the European Union
From the August 2000 edition of Managing Exports
It is estimated that over 50% of U.S. goods currently exported to European Union (EU) member nations fall under health, safety, or environmental product directives requiring ¤CE MarkingË for importation and sale. CE (Conformit╗ Europe└ne) indicates that a product so marked has met the obligations of EU legislation and can freely circulate within the 18-member European Economic Area (EEA). Therefore, export pros implementing Europe-wide export strategies for products falling under the EU directives need to fully understand CE Marking requirements█ and the consequences of not following them.
Passport to Greater Competitiveness
The EC describes the CE mark as a ¤passportË allowing exporters to circulate products freely within the internal market of the EU. Although CE marking is intended primarily for inspection purposes by EU member state inspectors, many consumers have come to perceive it as a quality mark. As a result, the CE Marking ¤seal of approvalË can increase your competitive edge.
EU member nations have so far taken the road of monitoring and educating exporters of goods not in compliance, rather than taking legal action. Impounding or return-to-origin of your export products is obviously a costly disaster. Financial penalties are in place, and national customs authorities always have the option of applying them.
Unfortunately, the directives are notoriously confusing█and undergo frequent updates. The EU does not publish a list of products covered by the directives, so U.S. exporters are responsible for determining the applicability of the EU directives to their products. Export managers are advised to seek expert advice, attend seminars, and do their research thoroughly (see accompanying provider list).
Why CE Marking? The goal of the EU standardization program is to streamline technical harmonization and the development of standards for certain product groups. The products affected include machinery, toys, construction products, personal protection equipment, nonautomatic weighing machines, medical devices, gas appliances, hot water boilers, and telecommunication terminal equipment.
Four directives (Machinery, Medical Device, Electromagnetic Compatibility, and Low Voltage) cover essential safety or other performance requirements, and are published in the Journal of the European Commission (EC: Web site, http://europa.eu.int). Three European standards organizations, CEN, CENELEC, and ETSI are mandated by the EC to develop CE Marking standards.
7 Steps to Obtain CE Marking
1) The first step for U.S. export pros is to obtain copies of the EU Directives to judge whether they apply to your company's product. In cases where more than one directive may apply, the CE mark can only be affixed if the product complies with all of the appropriate provisions in all of the directives applicable to the product.
2) The only agencies authorized to approve products for CE Marking are ¤Notified BodiesË that serve as independent test labs, appointed by the EU. Select a notified body whose area of expertise matches your product. Since pricing varies considerably, obtain price quotes for the testing and certification█and make sure the notified body accepts documents in English.
The Official Journal of the European Commission publishes a complete listing of Notified Bodies. In addition, 16 CE-Marking consultant firms affiliated with EU-competent Notified Body labs or EU-Notified Bodies are listed on the Web site of the Commerce Department's Trade Information Center (www.tradeinfo.doc.gov): Click on ¤Country Information,Ë then ¤Western Europe,Ë then ¤European Union,Ë then ¤CE Mark/Standards: Sources for Ordering Standards, Consulting Companies.Ë
3) Determine whether your company is eligible for the Commerce Department's Trade Adjustment Assistance program, which pays up to 50% of outside CE-Marking consultant or Notified Body costs. The program is administered by 12 regional Trade Adjustment Agencies (TAAC). For contact information, www.ita.doc.gov.
4) Depending on the level of risk associated with your product according to the EU directives, arrange for the tests, audits, or additional certification by the Notified Body. A ¤Conformity Assessment ProcedureË applicable to your product will outline the acceptable conditions available to you in obtaining CE Marking certification.
5) In most cases, you will be required to develop a technical file documenting and verifying the testing. This record must be available on demand.
6) The exporter must prepare a ¤Declaration of Conformity listing the directives the product meets and the exporter or manufacturer's name, address, and signature.
7) Once certification is obtained, the CE Mark must be affixed to the product, to its data plate or, where this is not possible or not warranted on account of the nature of the product, to its packaging, if any. The CE Mark must also be affixed to the accompanying documents. The CE mark must be affixed visibly, legibly, and indelibly. Where special provisions do not impose specific dimensions, the CE mark must have a height of at least five millimeters.
Option Exporters of products with minimal risk as outlined in the EU directives can exercise the self-certification option. Note, however, that some products, such as medical devices or dangerous machines, require third-party review or assessment by a laboratory in the United States that is designated by the EU as a ¤competent laboratory.Ë Self-certification involves the following steps:
1) Test your product to determine its conformance to the appropriate legal requirements and construct a technical file that can be located, if required, in Europe with your authorized representative or importer.
2) Affix the required CE Marking to your product before shipment to Europe.
3) Prepare a ¤Declaration of ConformityË and append it to the bill of lading. The Declaration must contain product identification, the European Directives complied with, standards used to verify compliance with the Directives, name of Notified Body if required. It must be signed on behalf of the manufacturer or the authorized representative and identify that signatory and provide the manufacturer's name and address. If you do not have a representative in the EU, you can issue the Declaration of Conformity to the Importer.
4) The Declaration of Conformity and technical files need only be written in English; however, instruction manuals need to be in the local language of the end user.
For More information European Commission: http://europa.eu.int. European Commission Web site for companies that wish to do business with the EU: http://europa.eu.int/business/en. The site explains public procurement, intellectual property rights, technical standards, funding opportunities, Single Market Rules, General Advice and Feedback, and Practical Information. SWBC Europe: www.SWBC.nl. Netherlands, fax: 011-31-294-414 687; e-mail: email@example.com. Free information desk for CE Marking questions.
CE Marking Resources
- "New Approach" Web site (www.NewApproach.org) includes: 1) Directives and Standards; 2) CENELEC (European Committee for Electro-technical Standardization); 3) CEN (European Committee for Standardization); 4) ETSI (European Telecommunications Standards Institute); 5) EFTA (European Free Trade Association).
- Delegation of the EC to the U.S. (www.eurunion.org/legislat/index.htm) includes: Guide to the Implementation of Directives Based on New Approach and Global Approach. This guide provides useful ¤How ToË information for CE Marking including responsibilities, compliance, conformity procedure, notified bodies and market surveillance.
- Commerce Department Contact for CE Mark: Bob Straetz, Office of the European Union and Regional Affairs, 202-482-4496; fax: 202-482-2897.
- U.S. Mission to the European Union: Suzanne Sene, Office of the Commercial Counselor (APO AE 090724), 40 Blvd. du Regent. B-1000 Brussels, Belgium, 011-32-2-513 3830; fax: 011- 32-2-513 1228.
- NIST Standards Information Program (SIP), http://ts.nist.gov/ncsi, includes: 1) National Center for Standards Certification Information (NCSCI); 2) SIP; 3) Publications on Standards and Conformity Assessment Activities; 4) Standards Assistance and Management Information. Contact: JoAnn Overman, NCSCI, Office of Standards Services, NIST, Gaithersburg, MD 20899; 301- 975-4037; fax: 301-926-1559; e-mail: firstname.lastname@example.org.