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 due to a 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. Click here 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.

Finland applies EU directives and standards. Standards adopted as Finnish national standards are mainly European or International Standards through technical committees or working groups of CEN or ISO. Each CEN or ISO committee has a representative in Finland in one of the standards writing bodies of the Finnish Standards Association, SFS https://www.sfs.fi/en. 

There are three Finnish organizations that implement and enforce standards at the national level. However, it is the central standardization organization, the Finnish Standards Association (SFS), that controls and coordinates national standardization. SFS develops, approves, publishes, and sells standards. Members include professional, commercial, and industrial organizations. The State of Finland is represented by the ministries. Additionally, the Finnish Standards Association operates as the national WTO Enquiry Point. SFS is a member of the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN).

Published National SFS Standards are sold in Finland through the SFS on-line store at https://www.sfs.fi/en. Distribution of SFS standards abroad is handled by national ISO member bodies. Standards have been published in almost every field. Standards are classified according to the International Classification of Standards (ICS).

The National Electrotechnical Standardization Organization (SESKO) represents Finland in the International Electrotechnical Commission (IEC) and European Committee for Electrotechnical Standardization (CENELEC). Its responsibility is to implement international standards in Finland and enforce them as national SFS standards. Electrotechnical standards in Finland can be found at http://www.sesko.fi/en.

The Finnish Transport and Communications Agency (Traficom) is responsible for telecommunications standardization in Finland. Traficom represents the national level standards in the International Telecommunication Union (ITU) and the European Telecommunications Standards Institute (ETSI). Traficom functions under the Ministry of Transport and Communications, https://www.traficom.fi/en/communications/communications-networks/traficom-coordinates-telecommunications-standardisation
 

Agricultural Standards

A general food law published in January 2002 established the general principles of EU food law. This Regulation introduced mandatory traceability throughout the feed and food chain as of January 2005. For specific information on agricultural standards, please refer to the Foreign Agricultural Service's website.

Export guides to import regulations and standards are also available at the Foreign Agricultural Service’s website: FAIRS Export Certificate Report
Standards

The Finnish Standards Association (SFS) works with 12 affiliates called ‘standards writing bodies’ that represent different economic sectors and participate in the development of standards. SFS itself is also a standards-writing body, and as such is responsible for some fields of standardization, including quality and environmental systems. The affiliated standards writing bodies are responsible for the development of standards in their respective fields.

EU standards are set by consensus-driven process initiated by industry or mandated by the European Commission and carried out by independent standards bodies, acting at the national, European, or international level. Participation is open to all interested parties, not just those entities with a manufacturing presence, and non-governmental organizations such as environmental and consumer groups are strongly encouraged to actively participate in European standardization. The drafting of specific EU standards is handled by three European standards organizations:

1. CEN, European Committee for Standardization, handling all other standards, http://www.cen.eu/cen/pages/default.aspx
2. CENELEC, European Committee for Electrotechnical Standardization, http://www.cenelec.eu/
3. ETSI, European Telecommunications Standards Institute, http://www.etsi.org/

The members of CEN and CENELEC are the national standards bodies of the member states. CEN and CENELEC standards are sold by the individual member states standards bodies. ETSI differs 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. ETSI’s portal can be found at http://portal.etsi.org/Portal_Common/home.asp.

The EU is taking steps to modernize its standardization policy. The Joint Initiative on Standardization (JIS), 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.

Testing, inspection and certification

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, from design to production, to facilitate acceptance of the final product. EU product legislation found at https://ec.europa.eu/growth/single-market/goods/building-blocks/conformity-assessment_en 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 a production quality control system, to a full quality assurance system. Conformity assessment bodies in individual Member States are listed in the New Approach Notification and Designated Organizations (NANDO) information system, NANDO

To promote market acceptance of the final product, there are many voluntary conformity assessment programs. CEN’s certification system is known as the Keymark, https://www.cen.eu/work/keymark/Pages/default.aspx. Neither CENELEC nor ETSI offer conformity assessment services.

Product Certification
The United States has a mutual recognition agreement with the EU which aims to benefit industry by providing easier access to conformity assessment. The agreement lays down the conditions under which the United States will accept tests performed by EU conformity assessment bodies. Find more information on approved conformity assessment bodies and the text of the agreement.

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. The Finnish Accreditation Service (FINAS) is the national accreditation body in Finland. It accredits laboratories, certification bodies, inspection bodies, providers of proficiency testing, environmental verifiers, and greenhouse gas verifiers. FINAS is a full member of International Laboratory Accreditation Cooperation (ILAC), European co-operation for Accreditation (EA), and International Accreditation Forum (IAF). Operators accredited by FINAS can use the international accreditation symbols (ILAC MRA and IAF MLA symbols) to communicate that they are covered by these international agreements. Companies can utilize these international agreements so that a company or authority operating in another country can confirm the recognition of FINAS's accreditation in their own country. Additionally, Finnish companies or authorities can confirm the recognition of an accreditation granted in another country. Legislation and accredited operators can be found at https://www.finas.fi/sites/en/.
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.

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. 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. Note more information about CE Marking.
 
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 and studies by committees. It also lists the standards reference numbers linked to legislation, Harmonized Standards.
Additionally, the Finnish Standards Association publishes SFS and ISO standards which are available on-line at https://sales.sfs.fi/en/index.html.stx. The SFS serves as a WTO Enquiry Point, https://www.sfs.fi/en/wto_enquiry_point, providing information on technical regulations, standards and verification methods currently being prepared and adopted in WTO member countries.

National Institute of Standards and Technology’s (NIST) Notify U.S. Service
Member countries of the World Trade Organization (WTO) are required under the Agreement on Technical Barriers to Trade (TBT Agreement) to report to the WTO all proposed technical regulations that could affect trade with other Member countries. The Notify U.S. Service is a free, web-based e-mail subscription service that offers an opportunity to review and comment on proposed foreign technical regulations that can affect your access to international markets. Register online at Internet URL: Notify U.S.

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
 Standards Coordination Office
100 Bureau Dr., Mail Stop 2100
Gaithersburg, Maryland 20899, USA
Tel: (301) 975-4000

CEN-CENELEC - European Committee for Standardization
Avenue Marnix 17, B – 1000 Brussels, Belgium
Tel: +32 2 550 0811

 CEN-CENELEC - European Committee for Electrotechnical Standardization
Rue de la Science 23 – B - 1040 Brussels, BelgiumTel : +32 2 550 0811

ETSI- European Telecommunications Standards Institute
Route des Lucioles 650
F-06560 Valbonne France - Sophia Antipolis Tel : +33 4 92 94 4200

SBS- Small Business Standards
4, Rue Jacques de Lalaing, B-1040 Brussels
Tel : +32 2 285 0727

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 2470

ECOS- European Environmental Citizens Organization for Standardization
Rue d’Edimbourg 26, B – 1050 Brussels, Belgium
Tel: +32 2 894 4668

EOTA- European Organization for Technical Assessment
Avenue des Arts 40 Kunstlaan, B – 1040 Brussels, Belgium
Tel: +32 2 502 6900
 

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.