Slovenia - Standards for TradeSlovenia - Standards for Trade
Overview
Based on the European Commission’s 2015 Single Market Strategy and the June 2016 EU standardization package, the EU’s Joint Initiative on Standardization establishes a shared vision for European standardization and determining the legal nature of standards and technical regulations. According to the Joint Initiative, standards must be timely, market-driven, and produced in an inclusive way that supports EU policies and international standardization, with most European standards market driven and initiated by businesses. Under the EU standardization package, standards are optional and voluntary and do not become a binding requirement unless so designated by a competent ministry. Slovenia recognizes all EU and international standards for trade.
Goods and services imported for sale in Slovenia must comply with prescribed standards and technical regulations and be certified by an authorized institution, if so prescribed by the appropriate ministry. Where there is no authorized institution for certification, the Republic of Slovenia’s Standards and Metrology Institute will issue a certificate. Certificates issued abroad are valid in Slovenia if there is a mutual recognition agreement between the issuing authority and the local issuing institution. Health, veterinary, phytosanitary, or ecological control is obligatory for some types of products such as foodstuffs and animals. The Slovenian Standards Institute is available to answer all questions pertaining to standards at sist@sist.si.
All technical goods and consumer durables imported into Slovenia must include technical instructions, a written guarantee statement, and, if necessary, instructions for use. In addition, the importer must guarantee product servicing and the supply of spare parts. A declaration including the name and type of product, name of manufacturer, and other prescribed data should be attached to the product. All such documents and declarations must be in Slovene.
If a contract with a foreign person, regulations of a foreign country, or a bilateral or international agreement requires that export or import goods be shipped with documents certified by a competent authority, the Chamber of Commerce and Industry of Slovenia or an authorized customs organization is the competent authority. If the regulations of the country in which the documents are to be used stipulate that the documents must be issued by a state body, the Ministry of Foreign Affairs is the competent issuing authority in Slovenia.
Products tested and certified in the United States to American standards may have to be re-tested and re-certified to EU requirements due to the EU’s different approach to protecting the health and safety of consumers and the environment. Where products are not regulated by specific EU technical legislation, they are subject to the EU’s General Product Safety Directive as well as to possible additional national requirements. Products in controlled product categories may not be legally sold in the EU unless they have met the necessary standards to receive the European Conformity (CE) marking.
European Union standards are harmonized across the 28 EU member states and European Economic Area countries to allow for the free flow of goods. While EU harmonization may facilitate access to the EU Single Market, manufacturers should be aware that mandatory regulations and voluntary technical standards might also function as barriers to trade if U.S. standards differ from those of the European Union. Note additional information on EU harmonization standards and the New Legislative Framework.
Standards
EU standards setting is 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. Non-governmental organizations, including environmental and consumer groups, play an important role in European standardization. Many EU standards are adopted from international standard setting bodies such as the International Standards Organization (ISO). EU standards are formally drafted by three European standards organizations:
CEN, CENELEC, and their national members and committees work jointly to develop and define standards to facilitate cross-border trade and support the implementation of European legislation. ETSI allows direct participation in its technical committees from non-EU companies with interests in Europe and offers some of its individual standards at no charge on its website. After the publication of a European standard, each national standards body or committee is obligated to withdraw any national standard conflicting with the new European standard, thereby ensuring harmonization.
In addition to the three standards developing organizations, the European Commission plays an important role in standardization by funding and encouraging small- and medium-sized companies and non-governmental organizations, such as environmental and consumer groups, to participate in the standardization process. The Commission also provides money to the standards bodies when it mandates standards development to the European Standards Organization for harmonized standards to be linked to EU technical legislation.
Given the EU’s vigorous promotion of its regulatory and standards system as well as generous development funding, the EU’s standards regime is broad and extends well beyond the EU’s political borders to include affiliate members such as Albania, Belarus, Macedonia, and Morocco, among others. In addition, the standards organizations of countries such as Mongolia, Kazakhstan, and Australia, which are not likely to become CEN members or affiliate members for political and geographical reasons, are recognized as “partner standardization bodies.”
The CEN and CENLEC websites include information on current EU standardization requirements. In addition to their respective annual work plans, CEN’s “what we do” page provides an overview of standards activities by subject. Both CEN and CENELEC allow databased searches, while ETSI’s portal.
Note additional information on the European Standardization System.
Testing, inspection and certification
Conformity Assessment
The European Union requires all manufacturers to submit their products to conformity assessment procedures to ensure they meet all applicable EU requirements and to prevent unsafe or noncompliant products from entering the market. EU product legislation provides manufacturers a number of options regarding conformity assessment depending on the level of risk involved in the use of their product, ranging from self-certification, type examination, and production quality control systems to full quality assurance systems. Conformity assessment bodies in individual member states are listed in the European Commission’s New Approach Notified and Designated Organizations (NANDO) Information System.
A number of voluntary conformity assessment programs are available to promote market acceptance of final products, including CENELEC’s conformity assessment program, CEN’s Keymark system, CENCER mark, and workshop agreement (CWA) Certification Rules. ETSI does not offer conformity assessment services.
Product Certification
To sell products in the EU’s 28 member states 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 a number of options to determine which safety/health concerns need to be addressed, which conformity assessment module is best suited to their manufacturing process, and whether to use EU-wide harmonized standards.
Products manufactured to standards adopted by CEN, CENELEC, and 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. Products designated accordingly can be marketed and circulate freely within the EU. Manufacturers that choose not to use the harmonized EU standards must demonstrate their product meets the essential safety and performance requirements. Trade barriers may arise when European standardization organizations adopt design rather than performance standards and when U.S. companies without a European presence do not have access to the appropriate standardization process.
The EU adopted the New Legislative Framework in 2010 to strengthen market surveillance of regulated products throughout the EU and to establish a blueprint for all CE marking legislation, harmonize definitions, and establish responsibilities for European accreditation. National control authorities of EU member states are primarily responsible for CE marking, which simplifies the task of essential market surveillance of regulated products. CE marking is not intended to require detailed technical information on the product, but should include sufficient information to enable inspectors to trace the product back to the manufacturer or the local contact established in the EU. Such 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 produce at any time, along with the product's technical file or the documents accompanying the product.
Competent national authorities may officially accredit independent testing and certification laboratories as notified bodies to test and certify products as meeting EU requirements. “European Accreditation” (EA) is an association of national accreditation bodies officially recognized by national governments to assess and verify against international standards organizations carrying out evaluation services such as certification, verification, inspection, testing, and calibration. 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 with EN45003 or ISO/IEC Guide 58.
Publication of technical regulations
The official gazette of the European Union, the Official Journal is published online daily and consists of two series covering draft and adopted legislation as well as case law, committee reports, and other information on technical regulations. The Official Journal also includes the standards reference numbers linked to legislation.
The Commission publishes national technical regulations on the its website.
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.
Information
The Slovenian Standards Institute (SSI) is responsible for national technical and quality standards in Slovenia. Information on specific local standards and certification requirements is available through SSI, by email at sist@sist.si, by telephone at +386-1-478 3013, or by fax at +386-1-478 3094).
Based on the European Commission’s 2015 Single Market Strategy and the June 2016 EU standardization package, the EU’s Joint Initiative on Standardization establishes a shared vision for European standardization and determining the legal nature of standards and technical regulations. According to the Joint Initiative, standards must be timely, market-driven, and produced in an inclusive way that supports EU policies and international standardization, with most European standards market driven and initiated by businesses. Under the EU standardization package, standards are optional and voluntary and do not become a binding requirement unless so designated by a competent ministry. Slovenia recognizes all EU and international standards for trade.
Goods and services imported for sale in Slovenia must comply with prescribed standards and technical regulations and be certified by an authorized institution, if so prescribed by the appropriate ministry. Where there is no authorized institution for certification, the Republic of Slovenia’s Standards and Metrology Institute will issue a certificate. Certificates issued abroad are valid in Slovenia if there is a mutual recognition agreement between the issuing authority and the local issuing institution. Health, veterinary, phytosanitary, or ecological control is obligatory for some types of products such as foodstuffs and animals. The Slovenian Standards Institute is available to answer all questions pertaining to standards at sist@sist.si.
All technical goods and consumer durables imported into Slovenia must include technical instructions, a written guarantee statement, and, if necessary, instructions for use. In addition, the importer must guarantee product servicing and the supply of spare parts. A declaration including the name and type of product, name of manufacturer, and other prescribed data should be attached to the product. All such documents and declarations must be in Slovene.
If a contract with a foreign person, regulations of a foreign country, or a bilateral or international agreement requires that export or import goods be shipped with documents certified by a competent authority, the Chamber of Commerce and Industry of Slovenia or an authorized customs organization is the competent authority. If the regulations of the country in which the documents are to be used stipulate that the documents must be issued by a state body, the Ministry of Foreign Affairs is the competent issuing authority in Slovenia.
Products tested and certified in the United States to American standards may have to be re-tested and re-certified to EU requirements due to the EU’s different approach to protecting the health and safety of consumers and the environment. Where products are not regulated by specific EU technical legislation, they are subject to the EU’s General Product Safety Directive as well as to possible additional national requirements. Products in controlled product categories may not be legally sold in the EU unless they have met the necessary standards to receive the European Conformity (CE) marking.
European Union standards are harmonized across the 28 EU member states and European Economic Area countries to allow for the free flow of goods. While EU harmonization may facilitate access to the EU Single Market, manufacturers should be aware that mandatory regulations and voluntary technical standards might also function as barriers to trade if U.S. standards differ from those of the European Union. Note additional information on EU harmonization standards and the New Legislative Framework.
Standards
EU standards setting is 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. Non-governmental organizations, including environmental and consumer groups, play an important role in European standardization. Many EU standards are adopted from international standard setting bodies such as the International Standards Organization (ISO). EU standards are formally drafted by three European standards organizations:
- CENELEC, European Committee for Electro Technical Standardization:
- ETSI, European Telecommunications Standards Institute:
- CEN, European Committee for Standardization, handling all other standards:
CEN, CENELEC, and their national members and committees work jointly to develop and define standards to facilitate cross-border trade and support the implementation of European legislation. ETSI allows direct participation in its technical committees from non-EU companies with interests in Europe and offers some of its individual standards at no charge on its website. After the publication of a European standard, each national standards body or committee is obligated to withdraw any national standard conflicting with the new European standard, thereby ensuring harmonization.
In addition to the three standards developing organizations, the European Commission plays an important role in standardization by funding and encouraging small- and medium-sized companies and non-governmental organizations, such as environmental and consumer groups, to participate in the standardization process. The Commission also provides money to the standards bodies when it mandates standards development to the European Standards Organization for harmonized standards to be linked to EU technical legislation.
Given the EU’s vigorous promotion of its regulatory and standards system as well as generous development funding, the EU’s standards regime is broad and extends well beyond the EU’s political borders to include affiliate members such as Albania, Belarus, Macedonia, and Morocco, among others. In addition, the standards organizations of countries such as Mongolia, Kazakhstan, and Australia, which are not likely to become CEN members or affiliate members for political and geographical reasons, are recognized as “partner standardization bodies.”
The CEN and CENLEC websites include information on current EU standardization requirements. In addition to their respective annual work plans, CEN’s “what we do” page provides an overview of standards activities by subject. Both CEN and CENELEC allow databased searches, while ETSI’s portal.
Note additional information on the European Standardization System.
Testing, inspection and certification
Conformity Assessment
The European Union requires all manufacturers to submit their products to conformity assessment procedures to ensure they meet all applicable EU requirements and to prevent unsafe or noncompliant products from entering the market. EU product legislation provides manufacturers a number of options regarding conformity assessment depending on the level of risk involved in the use of their product, ranging from self-certification, type examination, and production quality control systems to full quality assurance systems. Conformity assessment bodies in individual member states are listed in the European Commission’s New Approach Notified and Designated Organizations (NANDO) Information System.
A number of voluntary conformity assessment programs are available to promote market acceptance of final products, including CENELEC’s conformity assessment program, CEN’s Keymark system, CENCER mark, and workshop agreement (CWA) Certification Rules. ETSI does not offer conformity assessment services.
Product Certification
To sell products in the EU’s 28 member states 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 a number of options to determine which safety/health concerns need to be addressed, which conformity assessment module is best suited to their manufacturing process, and whether to use EU-wide harmonized standards.
Products manufactured to standards adopted by CEN, CENELEC, and 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. Products designated accordingly can be marketed and circulate freely within the EU. Manufacturers that choose not to use the harmonized EU standards must demonstrate their product meets the essential safety and performance requirements. Trade barriers may arise when European standardization organizations adopt design rather than performance standards and when U.S. companies without a European presence do not have access to the appropriate standardization process.
The EU adopted the New Legislative Framework in 2010 to strengthen market surveillance of regulated products throughout the EU and to establish a blueprint for all CE marking legislation, harmonize definitions, and establish responsibilities for European accreditation. National control authorities of EU member states are primarily responsible for CE marking, which simplifies the task of essential market surveillance of regulated products. CE marking is not intended to require detailed technical information on the product, but should include sufficient information to enable inspectors to trace the product back to the manufacturer or the local contact established in the EU. Such 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 produce at any time, along with the product's technical file or the documents accompanying the product.
Competent national authorities may officially accredit independent testing and certification laboratories as notified bodies to test and certify products as meeting EU requirements. “European Accreditation” (EA) is an association of national accreditation bodies officially recognized by national governments to assess and verify against international standards organizations carrying out evaluation services such as certification, verification, inspection, testing, and calibration. 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 with EN45003 or ISO/IEC Guide 58.
Publication of technical regulations
The official gazette of the European Union, the Official Journal is published online daily and consists of two series covering draft and adopted legislation as well as case law, committee reports, and other information on technical regulations. The Official Journal also includes the standards reference numbers linked to legislation.
The Commission publishes national technical regulations on the its website.
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.
Information
The Slovenian Standards Institute (SSI) is responsible for national technical and quality standards in Slovenia. Information on specific local standards and certification requirements is available through SSI, by email at sist@sist.si, by telephone at +386-1-478 3013, or by fax at +386-1-478 3094).