Describes the country's standards landscape, identifies the national standards and accreditation bodies, and lists the main national testing organization(s) and conformity assessment bodies.
Last Published: 12/14/2018

Overview
Products tested and certified in the United States to American standards are likely to have to be retested and re-certified to 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.

European Union legislation and standards created under the New Approach are harmonized across the 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. For a list of new approach legislation, go to: http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.main.
The New Approach is superseded by the New Legislative Framework (NLF) of 2010 which was put in place to serve as a blueprint for existing and future CE marking legislation.

While harmonization of EU legislation can facilitate access to the EU Single Market, manufacturers should be aware that regulations (mandatory) and technical standards (voluntary) might also function as barriers to trade if U.S. standards are different from those of the European Union.
 
Standard Organizations
https://www.export.gov/article?id=European-Union-Trade-Standards
 
Product Certification
To sell products in the EU market as well as in 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 various 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 section provides some background and clarification.
 
Products manufactured to standards adopted by CEN, CENELEC or ETSI, and referenced in the Official Journal as harmonized standards, are presumed to conform to the requirements of EU Directives. The manufacturer then applies the CE marking and issues a declaration of conformity. With these, the product will be allowed to circulate freely within the EU. A manufacturer can choose not to use the harmonized EU standards, but then must 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 marking 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.  As market surveillance was found lacking, the EU adopted the New Legislative Framework, which went into force in 2010.   As previously mentioned, this framework is like a blueprint for all CE marking legislation, harmonizing definitions, responsibilities, European accreditation and market surveillance.

The CE marking 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 local contact established in the EU. This detailed information should not appear next to the CE marking, but rather on the declaration 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
http://www.european-accreditation.org
Publication of Technical Regulations
http://eur-lex.europa.eu/oj/direct-access.html?locale=en
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/index_en.htm
http://ec.europa.eu/growth/tools-databases/tris/en/
http://www.nist.gov/notifyus/

 

EU Regulations:
https://www.export.gov/article?id=European-Union-Marking-Labeling-and-Packaging-Overview
 
Contacts:
U.S. Mission to the EU
Marianne Drain, Standards Attaché
Marianne.Drain@trade.gov
Tel: +32 2 811 5034
Ms. Liliana Popescu, Commercial Specialist
liliana.popescu@trade.gov
Tel: +32 2 811 5001
 
National Institute of Standards & Technology
Gordon Gillerman Standards Coordination Office
100 Bureau Dr.
Mail Stop 2100
Gaithersburg, Maryland 20899
Tel: (301) 975-4000
Website: http://gsi.nist.gov/global/index.cfm/L1-2/L2-2
 
CEN – European Committee for Standardization
Avenue Marnix 17
B – 1000 Brussels, Belgium
Tel: 32.2.550.08.11
Fax: 32.2.550.08.19
Website: http://www.cen.eu
 
CENELEC – European Committee for Electrotechnical Standardization
Avenue Marnix 17
B – 1000 Brussels, Belgium
Tel: 32.2.519.68.71
Fax: 32.2.519.69.15
Website: http://www.cenelec.eu
 
ETSI - European Telecommunications Standards Institute
Route des Lucioles 650
Sophia Antipolis
F-06560 Valbonne France
Tel: 33.4.92.94.42.00
Fax: 33.4.93.65.47.16
Website: http://www.etsi.org
 
SBS – Small Business Standards
4, Rue Jacques de Lalaing
B-1040 Brussels
Tel: 32.2.285.07.27  Fax : +32-2/230.78.61
Website: http://sbs-sme.eu/
 
ANEC - European Association for the Co-ordination of Consumer Representation in Standardization
Avenue de Tervuren 32, Box 27
B – 1040 Brussels, Belgium
Tel: 32.2.743.24.70
Fax: 32.2.706.54.30
Website: https://www.anec.eu/
 
ECOS – European Environmental Citizens Organization for Standardization
Rue d’Edimbourg 26
B – 1050 Brussels, Belgium
Tel: 32.2.894.46.68
Fax: 32.2.894.46.10
Website: http://ecostandard.org/
 
EOTA – European Organization for Technical Assessment (for construction products)
Avenue des Arts 40
B – 1040 Brussels, Belgium
Tel: 32.2.502.69.00
Fax: 32.2.502.38.14
Website: https://www.eota.eu/en-GB/content/home/2/185/

Trade Agreements

For a list of trade agreements with the EU and its Member States, as well as concise explanations, please see
http://ec.europa.eu/trade/policy/countries-and-regions/agreements/

Web Resources

Hungarian Customs and Finance Guards http://en.nav.gov.hu/
Hungarian Licensing and Export Control Office http://mkeh.gov.hu
Hungarian Standards Office: http://www.mszt.hu/angol/index_eng.htm
Hungarian Accreditation Board: http://www.nat.hu/
 
EU and U.S. websites:
https://www.export.gov/article?id=European-Union-Regulation-Resources

 

Prepared by our U.S. Embassies abroad. With its network of 108 offices across the United States and in more than 75 countries, the U.S. Commercial Service of the U.S. Department of Commerce utilizes its global presence and international marketing expertise to help U.S. companies sell their products and services worldwide. Locate the U.S. Commercial Service trade specialist in the U.S. nearest you by visiting http://export.gov/usoffices.


More Information

Hungary Industry Taxonomy Market Access Trade Development and Promotion