Products entering EU and tested and certified in the United States to American standards are likely to be retested and re-certified to EU requirements as a result of the EU’s 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 standards created under the New Approach are harmonized across the 27 EU Member States and European Economic Area countries to allow for the free flow of goods. A feature of the New Approach is CE marking. While harmonization of EU legislation can facilitate access to the EU Single Market, manufacturers should be aware that regulations and technical standards might also function as barriers to trade if U.S. standards are different from those of the European Union.
The supreme body for the Swedish standardization system is the Swedish Standards Council, SSR. The Council’s members include the state, the Federation of County Councils, Association of Local Authorities, Confederation of Swedish Enterprises, Federation of Swedish Commerce and Trade and the Swedish Bankers Association.
SSR manages the register of both adopted and withdrawn Swedish standards and approves the standardization bodies in Sweden. All standardization is currently carried out by three accredited standardization bodies: The Swedish Standards Institute (SIS) handles most business areas, Informationstekniska Standardiseringen (ITS) handles telecommunication issues and Svensk Elstandard (SEK) handles electronic and electro-technical application standards.
All three standardization bodies are working on both European and global levels. Products tested and certified in the U.S. to American standards are likely to have to be retested and re-certified to European Union (EU) requirements as a result of the EU’s different approach to the protection of the health and safety of consumers and the environment.
SIS is the Swedish member of the Council and Technical Board of ISO and serves on both the administrative and technical boards of the European Committee for Standardization. ITS acts as the national standardization body for Sweden at ETSI, European Telecommunication Standards Institute, and SEK is the Swedish member of both International Electrotechnical Commission, IEC and European Committee for Electrotechnical Standardization, CENELEC.
Conformity Assessment is a mandatory step for the manufacturer in the process of complying with specific EU legislation. Bodies that perform analysis, testing and certification in accordance with certain EC directives (medical devices, contracting (building and civil engineering) machinery, pressure vessels, toys etc.) must be notified to the European Commission. In Sweden, SWEDAC is the entity responsible for assessing and appointing these bodies, known as “Notified Bodies”, by formally notifying them to the European Commission and exercising oversight on them. SWEDAC is also responsible for assessing Conformity Assessment Bodies.
To promote market acceptance of the final product, there are a number of voluntary conformity assessment programs. CEN’s certification systems are the Keymark, the CENCER mark, and CEN workshop agreements (CWA) Certification Rules. CENELEC has its own initiative. ETSI does not offer conformity assessment services.
To sell products on the EU market of 27 Member States as well as 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 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. There is no easy way for U.S. exporters to understand and go through the process of CE marking, but hopefully this section provides some background and clarification.
Products manufactured to standards adopted by CEN, CENELEC and ETSI, and published 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. Although CE marking is intended primarily for inspection purposes by Member State inspectors, the consumer may well perceive it as a quality mark.
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 authorized representative established in the EU. This 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 provide at any time, together with the product's technical file), or the documents accompanying the product.
The Swedish National Testing and Research Institute is accredited for certification in the fields of environment (ISO14001, EMAS, Environmental product declarations, EPD), quality (ISP9000 series, QS 9000, EU directives), the workplace in accordance with the National Board of Occupations Safety and Health Code Statutes AFS 2001:1) and products (CE marking, P-marking). The certification requirements are set out in product standards, voluntary specifications or specified by public authorities.
SP Swedish National Testing and Research Institute
501 15 Boras
Tel. 46 33 16 50 00
Fax. 46 33 13 55 02
Intertek Semco Certification AB, an approved certification body accredited by SWEDAC, offers certification to the ISO 9000 series, QS 9000, ISO 14001 and QS 9000, AFS 1996:6 (Working Environment) and validations under EMAS, and also certification to SS 627799 (Information Security), and EPD (Environmental Product Declaration).
SWEDAC is the national accreditation body, working under the Ministry for Foreign Affairs and Ministry of Enterprise & Energy. SWEDAC assesses the competence of laboratories, certification and inspection bodies and is also the public authority responsible for regulations and surveillance in the field of legal metrology.
SWEDAC assesses the independence of laboratories and their competence to perform analysis, tests or calibration within IT, building technology, legal metrology, foodstuffs, medical technology. electrical technology, chemistry, clinical chemistry, mechanics, materials testing, water analysis or calibration within many different quantities.
The accreditation is performed in accordance with the international SS EN ISO/IEC 17025 standard. SWEDAC also issues certificates for Good Laboratory Practice (GLP) in accordance with OECD rules (OECD/GD 32 - Paris 1992) to laboratories that perform investigations of chemicals other than pharmaceuticals, hygienic or cosmetic products.
In conjunction with the Chemicals inspectorate, SWEDAC is also responsible for accreditation of bodies for testing of plant protection products in efficacy trials in accordance with GEP, 'Good Efficacy Practice' (EPPO Guidelines 152, 181).
Swedac, Styrelsen for Ackreditering och Teknisk Kontroll
Swedish Board for Conformity and Technical Control
S-501 15 Boras, Sweden
Tel: 46-33-177 700
Fax: 46-33-101 392
Independent certification bodies, known as notified bodies, have been officially accredited by competent authorities to test and certify to EU requirements. However, under U.S.-EU Mutual Recognition Agreements (MRAs), notified bodies based in the United States and referred to as conformity assessment bodies, are allowed to test in the United States to EU specifications, and vice versa. The costs are significantly lower which results in U.S. products becoming more competitive. At this time, the U.S.-EU MRAs cover the following sectors: EMC (in force), RTTE (in force), medical devices (in transition), pharmaceutical (on hold), recreational craft (in force) and marine equipment (in force). The U.S. Department of Commerce, National Institute of Standards and Technology (NIST), has a link on its website to American and European Conformity Assessment bodies operating under a mutual recognition agreement.
Accreditation is handled at Member State level. "European Accreditation" is an organization representing nationally recognized accreditation bodies. 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.
Labeling and Marking
Sweden does not require country of origin marking for imports. However, goods carrying incorrect designations of origin are prohibited, and products made to appear as produced or manufactured in Sweden may not be imported unless the correct foreign origin is clearly and durably marked thereon.
Special marking regulations and labeling requirements exist for pharmaceuticals, chemicals, food products and other product categories. Sweden has very strict health, sanitary and labeling rules and sophisticated capabilities for monitoring product quality.
A retail-size food package must show the name of the manufacturer, packer or importer, commercial name of the product, net metric weights or volume, ingredients in descending order of weight, last recommended date of consumption, and storage instructions if perishable or intended for infants. The information described above should be in Swedish and the local importers can assist NTM companies in arranging for proper labeling information.
Inspection and food labeling requirements were changed to conform to E.U. regulations when Sweden became a member of the E.U. on January 1, 1995.
Manufacturers are advised to take note that all labels require metric units although dual labeling is also acceptable. The use of language on labels has been the subject of a Commission Communication, which encourages multilingual information, while preserving the right of Member States to require the use of language of the country of consumption.
The EU has mandated that certain products be sold in standardized quantities. Council Directive 2007/45/EC, , harmonizes packaging of wine and spirits throughout the EU. Existing national sizes will be abolished with a few exceptions for domestic producers.
The EU eco-label is a voluntary label which US exporters can display on products that meet high standards of environmental awareness. The eco-label is intended to be a marketing tool to encourage consumers to purchase environmentally-friendly products. The criteria for displaying the eco-label are strict, covering the entire lifespan of the product from manufacture, to use, to disposal. These criteria are reviewed every three to five years to take into account advances in manufacturing procedures. There are currently twenty-three different product groups, and approximately 250 licenses have been awarded for several hundred products.
Applications to display the eco-label should be directed to the competency body of the member state in which the product is sold. The application fee will be somewhere between €300 and €1300 depending on the tests required to verify if the product is eligible. The eco-label also carries an annual fee equal to 0.15% of the annual volume of sales of the product range within the European community. However, the minimum annual fee is currently set at €500 and maximum €25,000. There are plans to significantly reform the eco-label in the near future, reducing the application and annual fees and expanding the product ranges significantly. It is also possible that future eligibility criteria may take into account carbon emissions.