Denmark has historically maintained a no-barrier policy and is often in the lead in the international combat against non-tariff barriers. Denmark has the best record of all EU countries regarding implementation of Single Market directives. Denmark applies no unilateral trade barriers against the U.S.A. Denmark is a member of the European Union, and the common external duty tariffs therefore apply to all products entering from non-EU countries, including the United States. Duties typically vary from 5.0% to 14% on industrial goods. Once goods have cleared customs in one EU country, they may circulate freely within the Union. A Value-Added-Tax (VAT) of 25% is applied on a non-discriminatory basis to all goods (and almost all services) sold in Denmark, whether imported or locally-produced.

As a consequence of Denmark’s membership in the E.U., certain agricultural products imported from non-EU countries are governed by the Common Agricultural Policy (CAP). Duties on these items which include cereal grains, rice, milk and milk products, beef and veal, olive oil and sugar are supplemented with a system of variable levies or other charges. The purpose of these is to equalize prices of imported commodities with those produced within the EU.

Trade Barriers

See Import Tariffs

Import Requirements and Documentation

With very few exceptions (alcoholic beverages, weapons and arms, certain drugs and chemicals, and certain food products), Denmark requires no import licenses. There are no special import restrictions or license requirements which constitute problems for U.S. industrial product exporters.

The clearance of goods through customs and payment of duties in Denmark and other EU countries are the responsibility of the importer or his appointed customs broker. A commercial invoice from the U.S. exporter is always required for the importer or his agent to clear goods through customs. Additional documentation requirements exist for agricultural products, chemical substances and other selected goods (see "import licenses" above). U.S. exporters are advised to follow the documentation requirements of their local importers. Once goods have been cleared and duty paid in one EU country, these goods may move freely within all EU member states.

U.S. Export Controls

Denmark’s export controls comply with EU regulations covering the four regimes: Nuclear Suppliers Group; Wassenaar (general products), Missile Technology Control Regime and the Australian Group (chemicals). In early 2001, Denmark implemented a new export control system for dual-use products modeled on the U.K. export control compliance code

Temporary Entry

Most foreign businesses needing to export temporarily into Denmark chose to do so by using an ATA Carnet. The United States Council for International Business (USCIB) is the National Guaranteeing Association for ATA and TECRO/AIT Carnets in the U.S. In Denmark the National Guaranteeing Association is the Danish Chamber of Commerce, Borsen, DK 1217 Copenhagen K, Denmark. Tel: +45 33-950500 or +45 33-950536 Fax: +45 33-325216, www.hts.dk

Labeling and Marking Requirements

The marking and labeling requirements for products sold in Denmark are numerous and vary from product to product. The requirements may stem from either Danish or EU laws and regulations. For the exporter to comply, the assistance of the Danish importer is essential. As a general rule, consumer products must be labeled in Danish or in a language that differs from Danish only slightly in spelling. As a practical matter, this means Norwegian and in some instances, Swedish. Certain products must be marked clearly with the country of origin. In some cases, the importer may do the marking following arrival of the goods in Denmark. Weights and measures must be stated in the metric system. Labels and marking must accurately describe the contents of packages. The responsibility for compliance with Denmark's marking and labeling regulations falls on the importer. Exporters, however, should carefully follow importer's instructions. Failure to do so can cause customs delays and extra expenses which may harm future business.

A substantial number of products must now be CE-marked prior to sale in Denmark and the rest of the EU CE marking (CE = Communité Europeen or European Community) is a statement by the manufacturer of a finished product, or his authorized representative in the E.U., that the product meets the essential requirements for that product as stipulated in all relevant EU directives. The purpose of the directives is to replace various national laws and requirements with harmonized European requirements, thus ensuring free movement of goods within the EU

There are currently 21 product directives, which require CE marking, but these directives cover a large number of sub-sectors and product ranges. Examples of these are: industrial machinery products, the electrical sector and medical products - these product directives have certain requirements stating which products are to be covered under their directive. Thus, each product directive will state, within its regulations, which products within that particular directive will require CE marking.

Currently the following 21 product directives require CE marking by the manufacturer:

73/23/EEC Low voltage (electrical equipment for specific voltage measuring)
87/404/EEC Simple pressure vessels
88/378/EEC Children's toys
89/106/EEC Building materials
89/336/EEC EMC (electro-magnetic compatibility)
89/686/EEC Personal protection equipment
90/384/EEC Non-automatic weight devices
90/385/EEC Active medical implants
90/386/EEC Gas Equipment
92/42/EEC New hot-water boilers - fluid/gaseous fuels
93/15/EEC Explosives for civilian use
93/42/EEC Medical equipment
94/9/EC Materials suitable for explosive atmospheric environments
94/25/EC Leisure boats
95/16/EC Elevators
96/57/EC Refrigerators & freezers for household use (energy efficient requirements)
97/23/EC Pressure vessels / equipment
98/37/EC Machines (formerly directive 89/392/EEC)
98/79/EC In-vitro medical diagnostic equipment
1999/5/EC Radio and telecommunications equipment
2000/9/EC Aerial Ropeway for transport of persons

Guidance on compliance with EU directives is available from the U.S. & Foreign Commercial Service office at the U.S. Mission to the EU in Brussels, Belgium.

Labeling of Food Products:
Most foods are covered by the general regulation on labeling of foods, but certain foods are covered by specific regulations as well, e.g. fish products, chocolate, fruit juice, marmalade products and food supplements.

Labeling of food additives (as such or in foods) is covered by a specific regulation on food additives.

All foods sold in Denmark must be marked with a batch-identifying code (a lot-number or a date of production). This is true for “bulk packed” products as well as pre-packed products – and is the only requirement for “bulk packed” products. All other information may be handed over to the importer in document form.

Normally, all pre-packed foods intended for the final consumer or catering establishments must be labeled according to the general rules prior to retail sale or catering service:

Name and address
Product designation
Net weight
Durability

The labeling language must be Danish. Certain words from other languages, which are very similar to Danish in spelling, may be used. In practice though, most of the labeling will have to be in Danish.

Products may not be sold with a standard U.S. label only. Stick-on labels can be used in addition to a U.S. label, or to cover certain text on the original label, which is not in conformity with Danish labeling requirements (e.g., nutritional information which does not appear in Danish).

Food additives must be declared in the ingredients, listed by functional class, followed by specific name or E-number, as defined in the food additives regulation and positive additive list. Flavors must be declared merely as “aroma,” and it is possible to state “natural, nature identical or artificial” in accordance with the definitions in the flavor regulation.

Nutrients may be added after permission is granted from the authorities. The allowed usage is very limited. Added nutrients may not be claimed on the label, but may only be declared in the ingredients list and in nutritional information.

Further details are described in the report: Food and Agricultural Import Regulations and Standards (FAIRS). The report, which is updated yearly, is available on the internet: http://www.fas.usda.gov/. The report includes sections on food laws, labeling requirements, food additive regulations, pesticide and other contaminants, copyright and trademark laws and import procedures.

Prohibited and Restricted Imports

See Import Requirements

Customs Contact Information

Customs procedures, including the classification and valuation of imported goods entering Denmark, are governed by EU rules. For information on import duties and tariffs, U.S. exporters may contact the Danish Customs Office listed below:

Central Customs and Tax Administration
Customs Center Copenhagen
Snorresgade 15
DK-2300 Copenhagen S
Tel: +45 32-887300
Fax: +45 32-951874
Standards Return to top

• Overview
• Standards Organizations
• Conformity Assessment
• Product Certification
• Accreditation
• Publication of Technical Regulations
• Labeling and Marking

Overview

Products tested and certified in the U.S. to American standards are likely to have to be retested and re-certified to European Union (EU) requirements as a result of the EU’s different approach to the protection of the health and safety of consumers and the environment. Where products are not regulated by specific EU technical legislation, they are always subject to the EU’s General Product Safety Directive as well as to possible additional national requirements. http://europa.eu.int/comm/consumers/cons_safe/prod_safe/index_en.htm

European Union standards created in recent years under the New Approach are harmonized across the 25 EU member states and European Economic Area countries in order to allow for the free flow of goods. A feature of the New Approach is CE marking. While harmonization of EU legislation can facilitate access to the EU Single Market, manufacturers should be aware that regulations and technical standards might also become barriers to trade if U.S. standards are different from those of the European Union.

Standards Organizations

The Danish Standards Association is a private, non-profit organization, which has been approved as a technological service institute (GTS institute). The mission of Danish Standards Association is to provide services within: standardization, certification and the communication of knowledge. Danish Standards Association is Denmark's national standardization body and one of the leading certification enterprises in Denmark.

In addition, Danish Standards Association has been designated as the National Enquiry Point for the World Trade Organisation. The WTO Enquiry Point is the official information centre for international standards, certification schemes and regulations in Denmark.

Danish Standards Association can answer questions regarding:

European, international and national standards certification services
Notifications
EU directives
Harmonized standards
CE marking

European Union
EU Standards setting is a process based on consensus initiated by industry or mandated by the European Commission and carried out by independent standards bodies, acting at the national, European or international level. There is strong encouragement for non-governmental organizations, such as environmental and consumer groups, to actively participate in European standardization.

Many standards in the EU are adopted from international standards bodies such as the International Standards Organization (ISO). The drafting of specific EU standards is handled by three European standards organizations:

CENELEC, European Committee for Electrotechnical Standardization http://www.cenelec.org

ETSI, European Telecommunications Standards Institute (www.etsi.org)

CEN, European Committee for Standardization, handling all other standards http://www.cenorm.be/

Standards are created or modified by experts in Technical Committees or Working Groups. The members of CEN and CENELEC are the national standards bodies of the member states, which have “mirror committees” which monitor and participate in ongoing European standardization. CEN and CENELEC standards are sold by the individual member states standards bodies as well as through the American National Standards Institute (ANSI) http://www.ansi.org/. ETSI is different in that it allows direct participation in its technical committees from non-EU companies that have interests in Europe and gives away its individual standards at no charge on its website. In addition to the three standards developing organizations, the Commission of the European Union plays an important role in standardization through its funding of the participation in the standardization process of small and medium sized companies and non-governmental organizations, such as environmental and consumer groups. It also provides money to the standards bodies when it mandates standards development to the European Standards Organization for harmonized standards that will be linked to EU technical regulations. All EU harmonized standards, which provide the basis for CE marking, can be found on www.newapproach.org

Due to the EU’s vigorous promotion of its regulatory and standards system as well as its generous funding for its business development, the EU’s standards regime is wide and deep - extending well beyond the EU’s political borders to include affiliate members (countries which anticipate to become full members in the future) such as Albania, Bulgaria, Croatia, Romania, FYR of Macedonia, and Turkey. Another category, called “partner standardization bodies” includes the standards organizations of South Africa, Egypt, Serbia/Montenegro and Ukraine, which are not likely to join the EU or CEN any time soon, but have an interest in participating in specific CEN technical committees. They agree to pay a fee for full participation in certain technical committees and agree to implement the committee’s adopted standards as national standards. Many other countries are targets of the EU’s technical assistance program, which is aimed at exporting EU standards and technical regulations to developing countries such as the Mediterranean and Balkan countries, some Latin American countries, China, and Russia.

To know what CEN and CENELEC have in the pipeline for future standardization, it is best to visit their websites. CEN’s “business domain” page provides an overview by sector and/or technical committee whereas CENELEC offers the possibility to search its database. ETSI’s portal (http://portal.etsi.org/Portal_Common/home.asp) leads to ongoing activities.

With the need to more quickly adapt to market needs, European standards organizations have been looking for “new deliverables” which are standard-like products delivered in a shorter timeframe. While few of these “new deliverables” have been linked to EU regulation, expectations are that they will eventually serve as the basis for a EU wide standard. www.cenorm.be/cenorm/workarea/sectorfora/isss(ict)/index.asp

Conformity Assessment

Conformity Assessment is a mandatory step for the manufacturer in the process of complying with specific EU legislation. The purpose of conformity assessment is to ensure consistency of compliance during all stages of the production process to facilitate acceptance of the final product. EU product legislation gives manufacturers some choice with regard to conformity assessment, depending on the level of risk involved in the use of their product. These range from self-certification, type examination and production quality control system, to full quality assurance system. You can find conformity assessment bodies in individual member state country in this list by the European Commission http://europa.eu.int/comm/enterprise/nando-is/home/index.cfm. To promote market acceptance of the final product, there are a number of voluntary conformity assessment programs. CEN’s certification systems are the Keymark, the CENCER mark, and the European Standard Agreement Group. CENELEC has its own initiative www.cenelec.org/Cenelec/Homepage.htm ETSI does not offer conformity assessment services.

Product Certification

To sell their product on the EU market of 25 member states as well as Norway, Liechtenstein and Iceland, U.S. exporters are required to apply CE marking whenever their product is covered by specific product legislation. CE marking product legislation offers manufacturers a number of choices and requires decisions to determine which safety/health concerns need to be addressed, which conformity assessment module is best suited to the manufacturing process, and whether or not to use EU-wide harmonized standards. There is no easy way for U.S. exporters to understand and go through the process of CE marking, but hopefully this chapter provides some background and clarification.

In the eighties, the New Approach was launched to overcome the lengthy adoption process of “old approach” type legislation. The goal of the European Union's harmonization program under the New Approach is to streamline technical harmonization and the development of standards for certain product groups, including, among others, machinery, toys, construction products, electromagnetic compatibility, personal protective equipment, non-automatic weighing instruments, medical devices, gas appliances, hot water boilers, and radio and telecommunications terminal equipment (RTTE). Under the New Approach, Directives cover essential safety, health and environmental requirements. The three regional European standards organizations, CEN, CENELEC and ETSI, are mandated by the Commission to develop technical standards that are consistent with the essential requirements of EU Directives.

Products manufactured to standards adopted by CEN, CENELEC and ETSI, and published in the Official Journal as harmonized standards, are presumed to conform to the requirements of EU Directives. The manufacturer then applies the CE Mark and issues a declaration of conformity. With these, the product will be allowed to circulate freely within the European Union. A manufacturer can choose not to use the harmonized EU standards, but must then demonstrate that the product meets the essential safety and performance requirements. Trade barriers occur when design, rather than performance, standards are developed by the relevant European standardization organization, and when U.S. companies do not have access to the standardization process through a European presence.

The CE mark addresses itself primarily to the national control authorities of the Member States, and its use simplifies the task of essential market surveillance of regulated products. Although CE marking is intended primarily for inspection purposes by EU Member State inspectors, the consumer may well perceive it as a quality mark.

The CE mark is not intended to include detailed technical information on the product, but there must be enough information to enable the inspector to trace the product back to the manufacturer or the authorized representative established in the EU. This detailed information should not appear next to the CE mark, but rather on the declaration of conformity, the certificate of conformity (which the manufacturer or authorized agent must be able to provide at any time, together with the product's technical file), or the documents accompanying the product.

Accreditation

The independent certification bodies, known as notified bodies, have been officially accredited by competent authorities to test and certify to EU requirements. However, under the U.S./EU Mutual Recognition Agreements (MRAs), notified bodies based in the United States and referred to as conformity assessment bodies, will be allowed to test in the United States to EU specifications, and vice versa. The costs will be significantly lower and U.S. products will, as a result, become more competitive. At this time, the U.S./EU MRAs cover the following sectors: EMC (in force), RTTE (in force), medical devices (in transition), pharmaceutical (in transition), and recreational craft (in force). This link lists to American and European Conformity Assessment bodies operating under a mutual recognition agreement http://ts.nist.gov/ts/htdocs/210/gsig/mra.htm

Accreditation is handled at member state level. “European Accreditation” (http://www.european-accreditation.org/) is an organization representing nationally recognized accreditation bodies. Membership is open to nationally recognized accreditation bodies in countries in the European geographical area that can demonstrate that they operate an accreditation system compatible with EN45003 or ISO/IEC Guide 58.

Publication of Technical Regulations

The Official Journal is the official gazette of the European Union. It is published daily and consists of two series covering draft and adopted legislation as well as case law, questions from the European Parliament, studies by committees, and more (http://europa.eu.int/eur-lex/en/index.html). It lists the standards reference numbers linked to legislation. (http://www.newapproach.org/Directives/DirectiveList.asp). National technical regulations are published on the Commission’s website http://europa.eu.int/comm/enterprise/tris/to allow other countries/interested parties to comment.

Labeling and Marking

Manufacturers should be mindful that, in addition to the EU’s mandatory and voluntary schemes, national voluntary labeling schemes might still apply. These schemes may be highly appreciated by consumers, and thus, become unavoidable for marketing purposes.

Manufacturers are advised to take note that all labels require metric units although dual labeling is also acceptable until end of December 2009. The use of language on labels has been the subject of a Commission Communication, which encourages multilingual information, while preserving the freedom of Member States to require the use of language of the country of consumption.

The EU has mandated that certain products be sold in standardized quantities. Council Directive 80/232/EC provides permissible ranges of nominal quantities, container capacities and volumes of a variety of products. http://europa.eu.int/eur-lex/en/consleg/main/1980/en_1980L0232_index.html

The Eco-label The EU adopted legislation in 1992, revised in 2000, to distinguish environmentally friendly production through a voluntary labeling scheme called the Eco-label. The symbol, a green flower, is a voluntary mark. The Eco-label is awarded to producers who can show that their product is less harmful to the environment than similar such products. This “green label” also aims to encourage consumers to buy green products. However, the scheme does not establish ecological standards that all manufacturers are required to meet to place product on the market. Products without the EU Eco-label can still enter the EU as long as they meet the existing health, safety, and environmental standards and regulations.

There are concerns in the United States that the EU Eco-labeling program may become a de facto trade barrier; may not enhance environmental protection in a transparent, scientifically sound manner; may not be open to meaningful participation by U.S. firms; and may discriminate unfairly against U.S. business. The EU Eco-label is a costly scheme (up to EUR 1,300 for registration and up to EUR 25,000/ year for the use of the label, with a reduction of 25 percent for SMEs) and has therefore not been widely used so far. However, the Eco-label can be a good marketing tool and, given the growing demand for green products in Europe, it is likely that the Eco-label will become more and more a reference for green consumers.

Trade Agreements

Denmark is a full member of the EU and the W.T.O.

Web Resources

Danish Standards Association (Dansk Standard)
Kollegievej 6
DK-2920 Charlottenlund
Tlf: +45 39 96 61 01
Fax: +45 39 96 61 02
www.ds.dk

U.S. Mission to the E.U.
Foreign Commercial Service
Rue Zinner 13
B - 1000 Brussels, Belgium
Fax: 32 2 513 1228
Gwen B. Lyle – Standards Attaché
Tel: 32 2 508 2674
gwen.lyle@mail.doc.gov
Sylvia Mohr – Standards Specialist
sylvia.mohr@mail.doc.gov
Tel: 32 2 508 2675
Fax: 32 2 513 1228

CEN – European Committee for Standardization
Rue de Stassart 36
B – 1050 Brussels, Belgium
Fax: 32 2 550 08 19
Tel: 32 2 550 08 25 / 550 08 11
www.cenorm.be

CENELEC – European Committee for Electrotechnical Standardization
Rue de Stassart 35
B – 1050 Brussels, Belgium
Tel: 32 2 519 68 71
Fax: 32 2 519 69 19
www.cenelec.org

ETSI - European Telecommunications Standards Institute
Route des Lucioles 650
F – 06921 Sophia Antipolis Cedex, France
Tel: 33 4 92 94 42 12
Fax: 33 4 93 65 22 99
www.etsi.org

European Commission
Enterprise Directorate - General
Rue de la Science 15
B – 1040 Brussels, Belgium
Mail: Office: SC15 02/09 B – 1049 Brussels
Tel: 32 2 299 56 72
Fax: 32 2 299 16 75
http://europa.eu.int/comm/enterprise/standards_policy/

EFTA – European Free Trade Association
Rue de Trèves 74
B – 1040 Brussels
Tel: 32 2 286 17 41
Fax: 32 2 286 17 42
http://www.efta.int/

NORMAPME – European Office of Crafts Trades and Small and Medium-Sized
Enterprises for Standardization
Rue Jacques de Lalaing 4
B – 1040 Brussels, Belgium
Tel: 32 2 282 05 31
Fax: 32 2 282 05 35
www.normapme.com

ANEC - European Association for the Co-ordination of Consumer Representation in Standardization
Avenue de Tervueren 36, Box 4
B – 1040 Brussels, Belgium
Tel: 32 2 743 24 70
Fax: 32 2 706 54 30
www.anec.org

ECOS – European Environmental Citizens Organization for Standardization
Boulevard de Waterloo 34
B – 1000 Brussels, Belgium
Tel: 32 2 289 10 93
Fax: 32 2 289 10 99

EOTA – European Organization for Technical Approvals (for construction products)
Avenue des Arts 40
B – 1040 Brussels, Belgium
Tel: 32 2 502 69 00
Fax: 32 2 502 38 14
info@eota.be

EOTC – European Organization for Conformity Assessment
Rue de Stassart 36
B – 1050 Brussels, Belgium
Tel: 32 2 502 40 40
Fax: 32 2 502 42 39
www.eotc.be