International Trade/Offshore Manufacturing/Sourcing/Export/Import/Consulting Selling Products To Europe By David Baker Is Europe a market worth exploring? The European Union has 370 million consumers who account for more than a fifth of world trade.They are hungry for the sophisticated high tech products produced in the U.S. And yet many American companies think Europe is a difficult market beset by protectionist rules and regulations. In this article, the aim is to give exporters the confidence that Europe is a market worth exploring, explaining how European product regulations can help exporters rather than act as obstacles to trade. The CE mark is designed to open up trade within Europe. Remember that the European Union was set up to provide a market in which goods could be traded without hindrance. To achieve this, European directives have been issued requiring countries in Europe to accept products that pass European standards of safety. If a product complies with a European product directive, it carries a CE mark, which indicates it can be sold throughout the European Union without having to pass any additional national requirements. This is the exporter's opportunity. If the product meets a CE marking directive, it can be sold legally throughout the European Union. One declaration opens the doors to all Europe. As you can imagine, the Europeans set themselves a daunting task to bring together the product standards from all the different countries in Europe. So the new directives bringing in CE marking started with something simple, toys, before steadily expanding every year to include machinery, electrical equipment, personal protective equipment, gas boilers, medical devices, lifts, weighing machines and small boats. In the future, CE marking will be mandatory for construction products, the efficiency of refrigerators and freezers, marine equipment, and eventually to cover every product sold in Europe. When a directive is issued, there is a transitional period to give time for manufacturers to meet the new requirements. At the end of this transitional period, it becomes law and all countries within the European Community must accept CE-marked products covered by the directive into their markets without any restrictions. Each directive sets out the essential requirements for a product range, and these are then made more precise in "harmonized" standards Ð harmonized because they incorporate the common safety features of the earlier national standards. The essential requirements are the legal requirement; meeting the standards is the recognized way to meet the essential requirements. An example would be safety goggles for use in industry. These come under the Personal Protective Equipment Directive 89/686/EEC. The appropriate standards are EN 166, which provides the specification for eye protection; EN 167, which describes the optical test methods to be used; and EN 168, which describes the test methods to determine the impact resistance and other mechanical properties. These European standards each contribute to satisfying the essential requirements. How do you get the CE mark? The different routes are spelled out in the directives. For simple equipment, it is often sufficient for the manufacturer to "self certify." The manufacturer designs the product to meet the essential requirements of the directive as detailed in any harmonized standards. He tests it to appropriate test schedules, puts all the technical details of the design, the tests and the standards in a technical file and declares the product meets the essential requirements in a declaration of conformity. For more complex equipment, or one that presents greater hazards, directives require an external agency to become involved. These bodies are known as notified bodies, as each country notifies the European Commission with the list of organizations that are acceptable to assess and test certain ranges of products. Although the notified body should have offices in Europe (so it is subject to European law) many of these bodies also have offices in the U.S. (e.g., BSI, SGS and TUV Rheinland). Others accept test results from reputable U.S. test houses, so it is not always necessary to have products tested in Europe. What do these notified bodies do? There are two main functions: the first is to review all the technical documentation presented to decide if it meets the requirements of the appropriate directive. The second is to determine whether the company can consistently manufacture product to the same standard as has been designed and tested. The more hazardous the product, the more thorough the assessment by a notified body has to be. Let us take another example. Company X makes a heart monitor. It is clearly a medical device, and because it monitors a vital physiological process, it is classified IIb, which requires a notified body to be involved. The most usual way for the notified body to be involved is using the full quality assurance route in which the notified body audits the quality system to the EN 46001 standard. In addition, the notified body would assess the technical file for adequacy before issuing an EC design examination certificate. The notified body also has the responsibility for periodically carrying out inspections to ensure the manufacturer still applies the approved quality system. There are other options, such as verification by the notified body, in which it verifies that production samples still conform; or assessment of the production system alone; or an assessment of the final inspection and testing system. In each, the notified body is involved in surveillance of the manufacturer's systems to ensure they continue to be capable of producing the products to the right standards. The first thing to do is to find out whether your product comes under CE marking legislation. The authoritative Web site, produced by the European Commission is: http://guagua.echo.lu/nasd/. This site provides the most up-to-date list of EC directives, and their associated harmonized standards. If a product appears to come under one of the directives, then you will need to obtain the directive and any relevant harmonized standards. European directives can be obtained from a wide variety of sources, and notified bodies such as BSI will sell you harmonized standards, at a price. To order standards from BSI, access: http://194.74.46.150/bsis/index.htm Another good source of documents can be found on: http://www.emc-resources.co.uk Finally, more information and assistance about the CE marking process can be found on the Atlantic Bridge Web site: http://www.atlanticbridge.co.uk Although the European CE marking directives seem complicated, they offer exporters to Europe the opportunity to sell to this vast market through a single regulatory compliance. In comparison to facing a host of different national regulations, this must be an improvement. When this article was first published, David Baker was a director of Atlantic Bridge Limited in Great Britain. Phone: 44 (0)1380 848 170. Advertise on this site Put your company on this site!