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). 

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. 

Standards 

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.