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 EU member states and European Economic Area countries to allow for the free flow of goods. While harmonization of EU legislation can facilitate access to the EU Single Market, manufacturers should be aware that regulations, which are mandatory, and technical standards, which are voluntary, might also function as barriers to trade when U.S. standards differ from those of the European Union, which is often the case. For more on how the EU standards and regulatory system functions as a barrier to trade, see page 177 in the National Trade Estimate maintained by the Office of the United States Trade Representative.
Standards
In general, the harmonization of EU standards has greatly simplified technical regulations amongst Member States. Prior to harmonization, each country in the European Union developed its own standards through its national standards body, leading to 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: the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute (ETSI).
CEN activities cover a broad range of areas and CENELEC addresses electrotechnical standards, 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 where a Harmonized European Standard (EN) can be developed. 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 have been mandated by the European Commission, have been developed by the European Standards Bodies above, address essential health and safety requirements, and notification of their development has been published in the Official Journal of the European Union.
Technically, the use of a Harmonized Standard is voluntary. A manufacturer can elect to use a Harmonized Standard or decide to use a non-Harmonized Standard (e.g., a standard developed by one of the many standards development organizations based in the United States) to meet essential requirements. However, when using a Harmonized Standard, the manufacturer is presumed to be in conformity with the law (Presumption of Conformity). EU harmonized standards that 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 the essential requirements. This proof may be provided by the manufacturer’s technical file, by the employment of a third party (e.g., consultant or testing house), or by a combination of the two.
In addition to the three EU standards developing organizations, the European Commission funds the participation of small- and medium-sized EU companies and non-governmental EU organizations, such as environmental, labor and consumer groups, in the standardization process. 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. The Commission requests CEN/CENELEC or TSI to develop standards.
There are also several European Standards (ENs) developed by CEN, CENELEC, and ETSI that are not mandated by the Commission and that do not necessarily define essential requirements. In theory, their use is voluntary. They may define other characteristics, such as durability, appearance, quality levels, or even cultural preferences. They may be test methods or measurement guides. These European Standards often have the advantage of recognition in the European marketplace. A standard that does not emanate from one of the European standards bodies is not always recognized by insurers, lending institutions, retailers, developers, market surveillance organizations, conformity assessment bodies, and consumers, and may hinder acceptance of the product in the marketplace, particularly when a well-known European Standard already exists for the same product.
Finally, given the European Union’s vigorous promotion of its regulatory and standards system, as well as its generous funding for its development, the European Union’s standards regime extends well beyond the European Union’s borders to include affiliate members (countries which are hopeful of becoming full members in the future). 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.
(Future standardization activities can be viewed on the CEN and CENELEC’s work plan. 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 webpage links to ongoing activities.)
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 27 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 2008 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.
Accreditation
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 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 its website.
Contact Information
Provide key contact information and list relevant standards and trade organizations. Include the standards point(s) of contact at Post including Standards Attachés where there is one located.
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). Standards Attaché for European Union is located in Belgium. “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. 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 or countries 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.”
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 notifications on past 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.
Visit the ITA website to learn more about certifying your product with CE marking.
Agricultural Standards
The establishment of harmonized EU rules and standards in the food sector has been ongoing for several decades, and the EU publicized a law establishing the general principles of EU food law in January of 2002. 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.