Trade FAQs

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Q. What is the TPCC ?
 
A. The Trade Promotion Coordinating Committee (TPCC) is an inter-agency task force that ensures the coordination and development of a government-wide export promotion plan. It is made up of 20 agencies with a core of 7 agencies: Department of Commerce (DOC) Export-Import Bank Overseas Private Investment Corporation (OPIC) U.S. Trade and Development Agency (USTDA) Small Business Administration (SBA) Department of State Department of Agriculture (USDA) This committee is chaired by the Secretary of Commerce and the Under Secretary of Commerce for International Trade. The TPCC has four main customer service initiatives: Training Trade specialists are trained as account managers that are aware of all TPCC agency programs and can assist in guiding you to the agency that can best assist you. Marketing Export information is disseminated through a variety of programs, such as Export.gov, USA export pavilion and the Ex-Im/SBA joint outreach program. Program Integration The TPCC agencies work together in providing services to US companies, such as Ex-IM/SBA Working Capital Co-guarantee and the Joint CS-State Partner Post Program. Information Sharing Agency databases are shared with other TPCC agencies through system integration, allowing the TPCC to provide U.S. companies with the most accurate and relevant information quickly.
 
Q. Can U.S. companies self-certify for the CE Marking?
 
A. 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. The manufacturer may affix the CE marking to his product once he's prepared a declaration of conformity, the certificate which shows the product conforms to the applicable requirements. He must maintain a technical file to prove conformity. The manufacturer or his authorized representative must be able to provide this certificate together with the technical file at any time, if requested by the appropriate member state authorities. There is no specific form for the declaration of conformity but specific information is required. The declaration must include the following: the manufacturer's name and address; the product description; the CE marking directives that apply to the product the European standards used; and, the signature of a company official for purposes of the company assuming liability for the safety of its product in the European market.
 
Q. Despite my CE marking why does my importer ask for an A.TR-1 Certificate? What is the A.TR-1-Certificate?
 
A. In the early stages of EU directives implementation, the Government of Turkey exhibited a bias towards CE marked products originating in Europe. The Government was suspicious of certificates of conformity originating outside of the European Union. The A.TR-1 Certificate is a document that establishes that goods are freely allowed to be sold to Turkey within the scope of Turkey's Customs Union with the European Union. Initially, companies were able to clear Turkish Customs easily by providing the Certificate of Conformity and the A.TR-1. Companies asked to ship via the European Union or are asked to acquire an A.TR-1 Certificate should contact the U.S. Embassy's Commercial Section for resolution of this matter. Any U.S. company providing evidence of directives conformity should be allowed access to the Turkish market without having to transship via the European continent.
 
Q. Do Turkish manufacturers need to confirm conformity of the EU New Approach (CE) Directives?
 
A. In April 2004, the Government of Turkey announced the adoption of the CE marking for imported products only. The Government of Turkey (Ministry of Industry, the Ministry of Labor and Social Security and the Ministry of Health) will need to promulgate regulations and legislation to have local companies also produce in compliance to the CE marking. At this time, the European Commission has not approved a Notified Body in Turkey. Therefore, Turkish companies requiring Notified Body conformity assessments must have products tested outside of Republic of Turkey.
 
Q. Does Turkey now require the CE Marking?
 
A. 1. My importer informed me that products being exported to Turkey require CE marking - is that true? On April 2004, The Government of Turkey's Undersecretariat for Foreign Trade announced the implementation of twenty-three European Union industrial directives, which would affect an estimated 70% of the manufactured products imported into Turkey. The Undersecretariat for Foreign Trade has adopted the EU's Low Voltage Directive, the Simple Pressure Vessels Directive, the Gas Appliances Directive, the Hot Water Boilers Directive, the EMC, the Machinery Directive, the Civil Explosives Directive, the Weighing Instruments Directive, the Equipment and Protective Systems Intended in Explosive Atmospheres Directive, the Lifts Directive (elevators), the Household Refrigerator/Freezer Directive, the Pressure Equipment Directive, the Noise Emission Directive, the Energy Efficiency for Ballast for Fluorescent Lighting Directive, the Active Implantable Medical Device Directive, the Medical Device Directive, the In Vitro Diagnostics Device Directive, the Toy Directive, the Recreational Water Craft Directive, the Construction Equipment Directive, the Personal Protective Equipment Directive, the Radio and Telecommunications Terminal Equipment Directive and the Cableway Directive (ski lifts and gondolas). All products that are deemed to fall within the European Union (EU) directives would need to conform to the directives in order to be sold in Turkey. 2. My importer informed me that I need a Certificate of Conformity issued by a Notified Body/Laboratory, is this true? Equipment meeting the directive definition of products needing to conform to EU technical regulations must have evidence of meeting the requirements either through verified laboratory testing conducted by an EU approved notified body or by manufacturer's self-declaration if the directive dictates. Companies selling to the Turkish market must submit evidence of conformity compliance (CE Marking) either by providing a notarized/consularized conformity certificate from a notified body or a corporate issued certificate of conformity, which declares compliance of all relevant standards and directive annexes. If the EU directives allow for company or self-declaration of conformity, then this would need to be accepted by the Republic of Turkey as well. For companies having difficulty in having its corporate declaration approved by the Government of Turkey, please contact Commercial Assistant Ms. Ozge Cirika at [email protected] 3. I supplied a corporate certificate of conformity with my shipping documents, why are my goods still detained at Turkish Customs? As Turkey has adopted the European Union New Approach Directives, it is still undergoing a learning process as to what are the Directives and what is CE marking. Exporters and importers are often asked for Certificates of Conformity prepared by EU recognized Notified Bodies. If a customs detainment takes place for companies that are allowed to self certify conformity based on the EU directives (i.e. low voltage, electromagnetic compatibility, portions of the machinery directive etc.), you would only need to contact Ms. Ozge Cirika at [email protected], and the Undersecretariat for Foreign Trade will be notified and a request to have the shipment released would be made. 5. I have been selling to the European Union without CE marking, why am I required to have CE marking for Turkey? As Turkey implemented the New Approach (CE marking) directives, it is still undergoing a learning process. Given that there is a full range of products not falling under the CE marking regulations, not all products are required to be CE marked or need to conform to EU standards. If companies find that the Government of Turkey asks for CE marking when none is required, please contact Ms. Cirika at [email protected] immediately. The Commercial Section will request that the Undersecretariat for Foreign Trade inform both Turkish Customs and the appropriate ministries to have the shipment released. 6. My importer informs me that my CE marked product would need to be inspected by the Turkish Standards Institute-is this true? When Turkey adopted the European New Approach Directive, products that are deemed to conform to the directives would not need to be inspected by the Turkish Standards Institute. As is the case in the EU, if Customs officers or the Government of Turkey believe that a product bearing CE marking may not be in conformity with the EU regulations, Turkish testing could be authorized. For U.S. companies being asked to have its products undergo additional Turkish Standards Institute testing despite evidence of directives conformity, please contact the Commercial Service in Ankara immediately. 7. Despite my CE marking why does my importer ask for an A.TR-1 Certificate? What is the A.TR-1-Certificate? In the early stages of EU directives implementation, the Government of Turkey exhibited a bias towards CE marked products originating in Europe. The Government was suspicious of certificates of conformity originating outside of the European Union. The A.TR-1 Certificate is a document that establishes that goods are freely allowed to be sold to Turkey within the scope of Turkey's Customs Union with the European Union. Initially, companies were able to clear Turkish Customs easily by providing the Certificate of Conformity and the A.TR-1. Companies asked to ship via the European Union or are asked to acquire an A.TR-1 Certificate should contact the U.S. Embassy's Commercial Section for resolution of this matter. Any U.S. company providing evidence of directives conformity should be allowed access to the Turkish market without having to transship via the European continent. 8. Do Turkish manufacturers need to confirm conformity of the EU New Approach (CE) Directives? In April 2004, the Government of Turkey announced the adoption of the CE marking for imported products only. The Government of Turkey (Ministry of Industry, the Ministry of Labor and Social Security and the Ministry of Health) will need to promulgate regulations and legislation to have local companies also produce in compliance to the CE marking. At this time, the European Commission has not approved a Notified Body in Turkey. Therefore, Turkish companies requiring Notified Body conformity assessments must have products tested outside of Republic of Turkey. 9. Who can I call on if I have a standards problem in Turkey? The United States Embassy's Commercial Section has been assisting U.S. companies, which meet EU directives conformity, in having products clear Turkish Customs as expeditiously as possible. The Commercial Section is also working to have the Government of Turkey accept CE conformity certification from U.S. corporations or Notified Bodies, without having U.S. companies face additional bureaucratic delays at customs and additional testing at the Turkish Standards Institute. For additional assistance in navigating the CE Marking regulations in Turkey, please contact our Commercial Assistant at [email protected] 10. Where can I find information on the CE Marking on the Internet? For additional information on the European Union Directives and European standards, please check the websites listed below: http://ts.nist.gov/Standards/Conformity/export-eu.cfm www.buyusa.gov/europeanunion http://ec.europa.eu/enterprise/index_en.htm www.newapproach.org
 
Q. How do European standards relate to the CE Marking?
 
A. Prior to the harmonization of standards under the New Approach, each European country developed its own standards through a national standards body. The new system provides for three standards bodies to create standards on a Europe-wide scale: The European Committee for Standardization (CEN) in Brussels, Belgium; the European Committee for Electrotechnical Standardization (CENELEC) in Brussels; 3) the European Telecommunications Standards Institute (ETSI) in Sophia Antipolis, France. CENELEC activities are in the electrotechnical sector, while ETSI specializes in telecommunications. CEN covers all other sectors. CEN and CENELEC's principal members are national standards bodies, while ETSI's membership incorporates a wider range of interested parties. These three are the only bodies that can develop a European standard (EN). When work on a European standard begins in one of these standards bodies, work on a corresponding national standard must stop. European standards, like European laws and European conformity assessment procedures, preempt and replace national (member state) standards. The European standards (ENs) that play a role in New Approach Directives are known as "harmonized standards." These standards supporting European legislation: are mandated by the European Commission; have been developed by the European standards bodies listed above, and address essential requirements of the New Approach Directives. These standards become officially recognized as harmonized standards when they are cited in the Official Journal of the European Communities. There is a vast body of European standards that is not mandated by the European Commission. These standards are not directed towards either the Old Approach or the New Approach Directives. While the use of these standards is in theory voluntary, they can support claims of a product's quality either for marketing or legal purposes. These standards cover such products as furniture, household appliances (non-electrical), sports equipment, carpeting, footwear and small hand-held tools (which are not covered by the Machinery Directive). They define characteristics such as durability, appearance, and quality.
 
Q. I have been selling to the European Union without CE marking, why am I required to have CE marking for Turkey?
 
A. As Turkey implemented the New Approach (CE marking) directives, it is still undergoing a learning process. Given that there is a full range of products not falling under the CE marking regulations, not all products are required to be CE marked or need to conform to EU standards. If companies find that the Government of Turkey asks for CE marking when none is required, please contact Ms. Cirika at [email protected] immediately. The Commercial Section will request that the Undersecretariat for Foreign Trade inform both Turkish Customs and the appropriate ministries to have the shipment released.
 
Q. I supplied a corporate certificate of conformity with my shipping documents, why are my goods still detained at Turkish Customs?
 
A. As Turkey has adopted the European Union New Approach Directives, it is still undergoing a learning process as to what are the Directives and what is CE marking. Exporters and importers are often asked for Certificates of Conformity prepared by EU recognized Notified Bodies. If a customs detainment takes place for companies that are allowed to self certify conformity based on the EU directives (i.e. low voltage, electromagnetic compatibility, portions of the machinery directive etc.), you would only need to contact Ms. Ozge Cirika at [email protected], and the Undersecretariat for Foreign Trade will be notified and a request to have the shipment released would be made.
 
Q. Is ISO 9000 required in order to get the CE Marking?
 
A. ISO 9000 registration (or EN 29000 certification) is used widely in Europe on a voluntary basis as a condition of acceptance of a manufacturer's product or as a way of recognizing the manufacturer's credibility. While a quality system such as ISO 9000 indicates that a company has an efficient organization structure and has low failure costs, it does not always certify conformity with the CE marking directives. However, some directives require use of a quality management system as part of the conformity assessment. For example, the Machine Directive requires manufacturers to set up a quality control system to make sure that future products coming off an assembly line meet CE marking requirements. However, the quality control system does not have to be ISO 9000, although ISO 9000 is a good choice, since it is widely recognized. The Medical Device Directive does require ISO 9000 (EN 13485) as part of the conformity assessment process.
 
Q. My importer informed me that I need a Certificate of Conformity issued by a Notified Body/Laboratory, is this true?
 
A. Equipment meeting the directive definition of products needing to conform to EU technical regulations must have evidence of meeting the requirements either through verified laboratory testing conducted by an EU approved notified body or by manufacturer's self-declaration if the directive dictates. Companies selling to the Turkish market must submit evidence of conformity compliance (CE Marking) either by providing a notarized/consularized conformity certificate from a notified body or a corporate issued certificate of conformity, which declares compliance of all relevant standards and directive annexes. If the EU directives allow for company or self-declaration of conformity, then this would need to be accepted by the Republic of Turkey as well. For companies having difficulty in having its corporate declaration approved by the Government of Turkey, please contact Commercial Assistant Ms. Ozge Cirika at [email protected]
 
Q. My importer informed me that products being exported to Turkey require CE marking - is that true?
 
A. On April 2004, The Government of Turkey's Undersecretariat for Foreign Trade announced the implementation of twenty-three European Union industrial directives, which would affect an estimated 70% of the manufactured products imported into Turkey. The Undersecretariat for Foreign Trade has adopted the EU's Low Voltage Directive, the Simple Pressure Vessels Directive, the Gas Appliances Directive, the Hot Water Boilers Directive, the EMC, the Machinery Directive, the Civil Explosives Directive, the Weighing Instruments Directive, the Equipment and Protective Systems Intended in Explosive Atmospheres Directive, the Lifts Directive (elevators), the Household Refrigerator/Freezer Directive, the Pressure Equipment Directive, the Noise Emission Directive, the Energy Efficiency for Ballast for Fluorescent Lighting Directive, the Active Implantable Medical Device Directive, the Medical Device Directive, the In Vitro Diagnostics Device Directive, the Toy Directive, the Recreational Water Craft Directive, the Construction Equipment Directive, the Personal Protective Equipment Directive, the Radio and Telecommunications Terminal Equipment Directive and the Cableway Directive (ski lifts and gondolas). All products that are deemed to fall within the European Union (EU) directives would need to conform to the directives in order to be sold in Turkey.
 
Q. My importer informs me that my CE marked product would need to be inspected by the Turkish Standards Institute-is this true?
 
A. When Turkey adopted the European New Approach Directive, products that are deemed to conform to the directives would not need to be inspected by the Turkish Standards Institute. As is the case in the EU, if Customs officers or the Government of Turkey believe that a product bearing CE marking may not be in conformity with the EU regulations, Turkish testing could be authorized. For U.S. companies being asked to have its products undergo additional Turkish Standards Institute testing despite evidence of directives conformity, please contact the Commercial Service in Ankara immediately.
 
Q. Once a U.S. company has certified its product with the CE Marking, is its work done?
 
A. No, a major challenge for U.S. firms that have CE-certified their products is to stay current on new standards coming on stream for their products. For example, the European standards bodies have developed some 900 standards for the Low Voltage Directive and around 185 standards for the Electromagnetic Compatibility Directive (EMC). Not only are new standards being issued, but these new standards in some cases have replaced standards that companies may have met earlier. European customs may look for reference numbers of widely-used standards on the Declaration of Conformity to assure compliance of products entering Europe. U.S. companies that use EMC or low voltage standards that have been replaced are considered to be noncompliant with CE marking requirements. Germany is one of the stricter countries for enforcing CE marking requirements. In a recent year the European Commission brought some 200 cases against companies, many in Asia, for noncompliance with the Low Voltage Directive. Some of these cases resulted in bans from the European market. U.S. companies and test houses must keep up-to-date on these new standards that will force changes in their testing and design plans.
 
Q. Under what conditions are U.S. companies unable to self-certify for the CE Marking?
 
A. 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. Notified bodies are independent testing houses or laboratories authorized by the EU member states to perform the conformity assessment tasks specified in the directives. A notified body may use a subcontractor to perform part(s) of a conformity assessment procedure. Many U.S. testing houses act as subcontractors to the EU notified bodies. However, the notified body is the ultimate authority, and a company must gain notified body approval in order to claim CE marking compliance for its project. For information on how to obtain a list of notified bodies, look at http://ec.europa.eu/enterprise/newapproach/nando. For a list of U.S. companies that subcontract to EU notified bodies, go to Testing/Certifying Labs on this website.
 
Q. What have the Europeans done to enforce the CE Marking requirements and what are the penalties for non-compliance?
 
A. European national agencies, such as Customs authorities and/or the Departments of Health, Industry and Labor, have been appointed to conduct market surveillance for CE marking. The purpose of this surveillance is to ensure that the provisions of the New Approach Directives have been met for products marketed within the European Union. In pursuit of this goal, surveillance authorities will: visit commercial, industrial and storage premises on a regular basis; visit work places and other premises where products are put into service and used; organize random checks; and, take samples of products for examination and testing. The surveillance authority can ask for the manufacturer's declaration of conformity and technical file after making a random check. The manufacturer, his authorized representative or the importer must be able to provide the technical file within seven to 10 days after the surveillance authority makes the request. If the product is found to be noncompliant, corrective action will depend on and be appropriate to the level of noncompliance. The surveillance authority will hold accountable the person responsible for affixing the CE marking to the noncompliant product. Others responsible for the noncompliance of the product will be held accountable as well. Penalties, which may include imprisonment, are determined by national law.
 
Q. What is the advantage of using European Standards?
 
A. Products that meet the applicable technical standards developed by the three standards organizations are presumed to conform to the requirements of EU directives and are allowed to circulate freely within the European Union. Use of European standards is seen as a "fast track" for gaining CE marking compliance for a product. For many products, though, a manufacturer can choose not to comply with the CEN, CENELEC, or ETSI standards, if the firm can demonstrate that its product satisfies the essential safety and health requirements of the directives.
 
Q. What is the CE Marking, and what is its purpose?
 
A. The European Commission describes the CE marking (an acronym for the French phrase "Conformite Europeenne") as a "passport" that allows manufacturers to circulate industrial products freely within the internal market of the EU. The CE marking certifies that the products have met EU health, safety and environmental requirements that ensure consumer and workplace safety. All manufacturers in the EU and abroad must affix the CE marking to those products covered by the "New Approach" directives in order to market their products in Europe. Once a product receives the CE marking, it can be marketed throughout the EU without having to undergo further product modification.
 
Q. What is the EU's New Approach to product certification?
 
A. The European Union (EU) developed "New Approach" Directives to streamline product approvals for a broad range of goods in order to facilitate trade within the EU single internal market. The "Old Approach" Directives contained a high degree of technical detail. EU member states introduced national standards or regulations at a faster pace than the European Commission could finalize these "Old Approach" Directives. These national specifications often proved to be trade barriers. New Approach Directives are limited to essential health and safety requirements for sectors such as machinery, electrical products, or medical devices. They do not cover specific products such as motor vehicles, cosmetics, or chemicals, which are still covered under the Old Approach Directives. The main difference between the New and Old Approach Directives is that under the New Approach, the technical details outlining the minimum requirements a product must meet are usually not found in the directive itself. The New Approach Directives are more general. Technical details on how to meet these minimum health and safety requirements are left to the following three groups: 1) Manufacturers who self-certify products by meeting the requirements of the applicable directives, in some cases by using appropriate European standards; 2) the three regional European standards organizations (CEN, CENELEC and ETSI), which now develop Europe-wide standards covering product sectors falling under the New Approach Directives; and, 3) government-appointed product certification bodies (called notified bodies), which provide testing and product approvals. Under the New Approach, the European Commission gives mandates to the European standards organizations to develop technical standards that meet the essential health and safety requirements of CE Marking directives. The New Approach Directives are designed to facilitate product certification, to maintain a high level of consumer and workplace safety, and to expand intra-European trade.
 
Q. What is the significant impact of the radio and telecommunications terminal (R&TTE) Directive?
 
A. This directive shows how not only standards but directives can change as a result of the CE marking program. The R&TTE Directive (1999/5/EC) went into force on April 8, 2000 and replaces the previous directive on telecommunications terminal equipment (98/13/EC). The purpose of the new directive is to cover both radio and telecommunications terminal equipment. The new R&TTE Directive allows manufacturers of telecommunications terminal equipment to self-certify, an option they didn't have in the past, by adhering to the appropriate European standards and getting a test result from a qualified laboratory, preferably an EU-affiliate lab. (There are EU-affiliate labs in the United States.) Types of equipment for which manufacturers can now self-certify include fax machines, phones, modems, and digital telecom equipment. Manufacturers of radio communications and wireless equipment will still need to get their product certified at an EU-affiliate lab authorized by a notified body. Under the U.S.-EU Mutual Recognition Agreement (MRA) on telecom, there are now U.S. labs that are certified to do testing and certification for the R&TTE Directive. For a list of these labs, consult the website: http://ts.nist.gov/mra. Manufacturers who have already complied with the old directive (1999/5/EC), and whose product has been put in service will not need to re-certify their products, but they will have to take off the old marking, put on the CE marking, and be able to back up the CE marking with technical documentation. Manufacturers who have products in inventory certified under the old directive will have until April 2001 to sell their products. After that, only products certified under the R&TTE Directive will be allowed to enter the European market. For more information on the R&TTE Directive, consult the website: http://ec.europa.eu/enterprise/rtte/index_en.htm.
 
Q. Where can I find information on the CE Marking on the Internet?
 
A. For additional information on the European Union Directives and European standards, please check the websites listed below: http://ts.nist.gov/Standards/Conformity/export-eu.cfm www.buyusa.gov/europeanunion http://ec.europa.eu/enterprise/index_en.htm www.newapproach.org
 
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