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.

Overview
Products tested and certified in the United States to U.S. regulations and 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 to allow for the free flow of goods.  An example of the New Approach is CE marking.
 
The concept of New Approach legislation is slowly disappearing as the New Legislative Framework (NLF), which entered into force in January 2010, was put in place to serve as a blueprint for existing and future CE marking legislation.  Existing legislation has been reviewed to bring them in line with the NLF concepts, which means that, as of 2016, new requirements are being addressed and new reference numbers are to be used on declarations of conformity.  For more information about the NLF.

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.

Agricultural Standards
The establishment of harmonized EU rules and standards in the food sector has been ongoing for several decades, and in January 2002 the EU publicized a general food law establishing the general principles of EU food law.  This Regulation introduced mandatory traceability throughout the feed and food chain as of Jan 1, 2005.  For specific information on agricultural standards, please refer to the Foreign Agricultural Service's website/.

There are also export guides to import regulations and standards available on the Foreign Agricultural Service’s website: FAIRS Export Certificate Report.

Standards
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:

  1. CEN, European Committee for Standardization
  2. CENELEC, European Committee for Electrotechnical Standardization
  3. ETSI, European Telecommunications Standards Institute
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" that monitor and delegate experts to participate in ongoing European standardization.  CEN and CENELEC standards are sold by the individual Member States standards bodies.  ETSI is different in that it allows direct participation in its technical committees from non-EU companies that have interests in Europe and provides some of its individual standards at no charge on its website.  In addition to the three standards developing organizations, the European Commission 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, labor and consumer groups. The Commission also provides money to the European standards bodies when it mandates standards development for harmonized standards that will be linked to EU legislation. Mandates– or requests (the Commission requests CEN/CENELEC or ESTI to develop standards) for standards.

Given the EU’s vigorous promotion of its regulatory and standards system as well as its generous funding for its development, the EU’s standards regime is wide and deep - extending well beyond the EU’s political borders to include affiliate members (countries which are hopeful of becoming full members in the future) such as the Western Balkan countries among others.  Another category, called "companion standardization body" includes the standards organization of Morocco, Israel, Kazakhstan and Australia, among others which are not likely to become a CEN member or affiliate for political and geographical reasons.

To view what CEN and CENELEC have in the pipeline for future standardization, it is best to visit their websites.  Other than their respective annual work plans, CEN’s "what we do" page provides an overview of standards activities by subject.  Both CEN and CENELEC offer the possibility to search their respective database. ETSI's portal links to ongoing activities.

The European Standardization system and strategy was reviewed in 2011 and 2012. The new standards regulation 1025, adopted in November 2012, clarifies the relationship between regulations and standards and confirms the role of the three European standards bodies in developing harmonized standards (EN)[1].  The emphasis is also on referencing international standards where possible.  For information, communication and technology (ICT) products, the importance of interoperability standards has been recognized.  Through a relatively recent mechanism, a “Platform Committee” reporting to the European Commission will decide which deliverables from fora and consortia might be acceptable for public procurement specifications.  The European standards bodies have been encouraged to improve efficiency in terms of delivery and to look for ways to include more societal stakeholders in European standardization.  The Joint Initiative on Standardization, launched in 2016 with a number of action items to improve European standardization, involves a large group of stakeholders who are committed to deliver results by 2019.

Key Links:           EU Standardization Policy
                              National Standards Authority of Ireland

Testing, Inspection and Certification
Conformity Assessment
Conformity Assessment is a mandatory step for the manufacturer in the process of complying with specific EU harmonized legislation.  The purpose of conformity assessment is to ensure consistency of compliance during all stages, from design to production, to facilitate acceptance of the final product.  EU product legislation gives manufacturers some choice regarding 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. Conformity assessment bodies in individual Member States are listed in the New Approach Notification and Designated Organizations (NANDO) information system.
Key Link: NANDO
 
To promote market acceptance of the final product, there are a number of voluntary conformity assessment programs. CEN’s certification system is known as the Keymark.  Neither CENELEC nor ETSI offer conformity assessment services.

Product Certification
To sell products in the EU market of 28 Member States as well as in EFTA (Norway, Liechtenstein Iceland, Switzerland) and Turkey 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. The CE marking process is very complex and this section attempts to provide 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 essential requirements of EU harmonized legislation. 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 and EFTA. 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 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 mentioned before, 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
Independent test and certification laboratories, known as notified bodies, have been officially accredited by competent national authorities to test and certify to EU requirements.

"European Accreditation" 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 to appropriate EN and ISO/IEC standards.

Publication of Technical Regulations
The Official Journal of the EU is the official publication of the European Union.  It is published daily on the internet and consists of two series covering adopted legislation as well as case law, studies by committees. It also lists the standards reference numbers linked to legislation (Harmonized Standards).   National technical regulations are published on the Commission's website to allow other countries and interested parties to comment.

National Institute of Standards and Technology’s (NIST) Notify U.S. Service
Members of the World Trade Organization (WTO) are required under the Agreement on Technical Barriers to Trade (TBT Agreement) to notify to the WTO proposed technical regulations and conformity assessment procedures that could affect trade.

Notify U.S. (www.nist.gov/notifyus) is a free, web-based e-mail registration service that captures and makes available for review and comment key information on draft regulations and conformity assessment procedures.  Users receive customized e-mail alerts when new notifications are added by selected country(ies) and industry sector(s) of interest, and can also request full texts of regulations.  This service and its associated web site are managed and operated by the USA WTO TBT Inquiry Point housed within the National Institute of Standards and Technology, part of the U.S. Department of Commerce.

Contact Information
U.S. Mission to the EU
Marianne Drain, Standards Attaché
Marianne.Drain@trade.gov
Tel: +32 2 811 5034

Liliana Popescu, Commercial Specialist
Liliana.Popescu@trade.gov
Tel: +32 2 811 5001

National Institute of Standard & Technology
Gordon Gillerman Standards Coordination Office
100 Bureau Dr.
Mail Stop 2100
Gaithersburg, Maryland 20899
Tel: (301) 975-4000

CEN- European Committee for Standardization
Avenue Marnix 17
B – 1000 Brussels, Belgium
Tel: +32.2.550.08.11
Fax: +32.2.550.08.19

CENELES- European Committee for Electrotechnical Standardization
Avenue Marnix 17
B – 1000 Brussels, Belgium
Tel: +32.2.519.68.71
Fax: +32.2.519.69.15

ETSI- European Telecommunications Standards Insitute
Route des Lucioles 650
Sophia Antipolis
F-06560 Valbonne France
Tel: +33.4.92.94.42.00
Fax: +33.4.93.65.47.16

SBS- Small Business Standards
4, Rue Jacques de Lalaing
B-1040 Brussels
Tel: +32.2.285.07.27
Fax: +32-2/230.78.61

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

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

EOTA- European Organization for Technical Assessment
Avenue des Arts 40
B – 1040 Brussels, Belgium
Tel: +32.2.502.69.00
Fax: +32.2.502.38.14

National Standards Authority of Ireland (NSAI)
Glasnevin, Dublin 9, Ireland
Website: http://www.nsai.ie

U.S. Commercial Service Dublin
Padraig O'Connor, Commercial Advisor
Tel: +353.1.2375848
Email: Padraig.O’Connor@trade.gov
Website: http://www.export.gov/ireland
 
 
[1] An EN standard is a standard developed by CEN/CENELEC and ETSI at the request of the EC in order to meet the essential requirements or other provisions of relevant European Union harmonization legislation

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.