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.
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 which is often the case.
In general, the harmonization of several EU standards has greatly simplified technical regulation in Europe. Prior to harmonization, each country in the EU developed its own standards through their national standards body creating differing and conflicting standards, laws, and conformity assessment procedures. Thus, it became necessary to create a new, integrated, European system of standardization. The new system provided for three EU standards bodies to create standards on a Europe-wide level: (1) The European Committee for Standardization (CEN); (2) The European Committee for Electrotechnical Standardization (CENELEC); and (3) The European Telecommunications Standards Institute (ETSI). CEN/CENELEC activities are in the electrotechnical and other sectors, while ETSI specializes in telecommunications. CEN and CENELEC’s principal members are member state national standards bodies. ETSI’s membership has a broader range of interested parties. These three are the only recognized bodies from which a Harmonized European Standard (EN) can come. When the development of a European Harmonized Standard begins in one of these organizations, development of a national standard must stop. Harmonized Standards are standards that support European legislation. They (1) have been mandated by the European Commission, (2) have been developed by the European Standards Bodies above, (3) address essential health and safety requirements; and (4) notification of their development has been published in the Official Journal of the European Union.
Technically, the use of a Harmonized Standard is voluntary. That is, a manufacturer can elect to use a Harmonized Standard, or decide to use a non-Harmonized Standard (an American Standard, for example) to meet essential requirements. However, when using a Harmonized Standard, the manufacturer is presumed in conformity with the law (Presumption of Conformity). Specific EU harmonized standards which confer presumption of conformity are listed in the directive or regulation usually in Annex Z or ZZ. On the contrary, using a standard that is not a Harmonized Standard will impose additional responsibilities. The use of anything but an EU Harmonized Standard, places a burden of proof upon the manufacturer that the product meets essential requirements. This proof may be provided by the manufacturer’s Technical File, by the employment of a third party (consultant, testing house, etc.), or by a combination of the two.
Finland applies EU directives and standards. The Finnish Standards Association, SFS is the central standardization organization that controls and co-ordinates national standardization work in Finland. SFS members include professional, commercial, and industrial organizations as well as the state of Finland. SFS develops, approves, and publishes national SFS standards. It also sells standards and communicates information about the standards and standardization to the public. In addition, SFS operates the national WTO Enquiry Point. SFS is a member of the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN). The majority of SFS standards are based on international or European standards. SFS prepares standards together with its affiliates called ‘standards writing bodies’.
Published National SFS Standards are sold in Finland through the SFS on-line store. 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.
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).
The Finnish Standards Association (SFS) works with 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: CEN, European Committee for Standardization, handling all other standards, CENELEC, European Committee for Electrotechnical Standardization, and ETSI, European Telecommunications Standards Institute.
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.
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. Under this regulation, “traceability” means the ability to track any food, feed, food-producing animal, or substance that will be used for consumption through all stages of production, processing, and distribution.
Testing, Inspection and Certification
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 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.
To promote market acceptance of the final product, there are many voluntary conformity assessment programs. CEN and Cenelec’s certification system is known as the Keymark. ETSI does not offer conformity assessment services.
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.
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 for Finland, responsible for assessing the competence and capability of organizations that provide certification, testing, inspection, and calibration services. FINAS is the Accreditation Department within the Finnish Safety and Chemicals Agency, Tukes. 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.
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 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.
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.
Publication of Technical Regulations
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, among others. It also lists the standards reference numbers linked to legislation, Harmonized Standards.
Additionally, the Finnish Standards Association publishes SFS and ISO standards. The SFS serves as a WTO Enquiry Point providing information on technical regulations, standards and verification methods currently being prepared and adopted in WTO member countries.
Jim Curtis, Standards Attaché
Gordon Gillerman Standards Coordination Office 100 Bureau Dr.
Mail Stop 2100
Gaithersburg, Maryland 20899
Tel: +1 (301) 975-4000
Rue de la Science 23
B – 1040 Brussels, Belgium
Rue de la Science 23
B – 1040 Brussels, Belgium
Route des Lucioles 650
F-06560 Valbonne France
Tel: +22.214.171.124.42.00 200
Use ePing to review proposed technical regulations and conformity assessment procedures.
The ePing SPS&TBT platform (https://epingalert.org/), or “ePing”, provides access to notifications made by World Trade Organization (WTO) Members under the Agreements on Sanitary and Phytosanitary Measures (SPS) and Technical Barriers to Trade (TBT), distributed by the WTO from January 16, 1995 to present. ePing is available to all stakeholders free of charge and does not require registration unless the user wishes to receive customized e-mail alerts. Use it to browse past notifications as well as new draft and updated product regulations, food safety and animal and plant health standards and regulations, find information on trade concerns discussed in the WTO SPS and TBT Committees, locate information on SPS/TBT Enquiry Points and notification authorities, and to follow and review current and past notifications concerning regulatory actions on products, packaging, labeling, food safety and animal and plant health measures in markets of interest.
Notify U.S., operated and maintained by the National Institute of Standards and Technology (NIST) since 2003 to distribute and provide access to notifications (and associated draft texts) made under the WTO TBT Agreement for US stakeholders, has reached its end of life. Per obligation under the TBT Agreement, each WTO Member operates a national TBT (and an SPS) Enquiry Point. National TBT Enquiry Points are authorized to accept comments and official communications from other national TBT Enquiry Points, which are NOT part of the WTO or the WTO Secretariat. All comment submissions from U.S. stakeholders, including businesses, trade associations, U.S domiciled standards development organizations and conformity assessment bodies, consumers, or U.S. government agencies on notifications to the WTO TBT Committee should be sent directly to the USA WTO TBT Inquiry Point. Refer to the comment guidance at https://tsapps.nist.gov/notifyus/data/guidance/guidance.cfm for further information. This guidance is provided to assist U.S. stakeholders in the preparation and submission of comments in response to notifications of proposed foreign technical regulations and conformity assessment procedures.