Sweden - Standards for Trade Sweden - Trade Standards
Overview
Products tested and certified in the United States to American standards are likely to have to be retested and re-certified to EU requirements due to 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 legislation and standards created under the New Approach are harmonized across the Member States and European Economic Area countries to allow for the free flow of goods. An example of the New Approach is CE marking.
The concept of New Approach legislation is slowly disappearing as the New Legislative Framework (NLF), which entered into force in January 2010, was put in place to serve as a blueprint for existing and future CE marking legislation. Existing legislation has been reviewed to bring them in line with the NFL concepts, which means that, as of 2016, new requirements are being addressed and new reference numbers are to be used on declarations of conformity. More information about the NLF.
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.
Standards
EU standards setting is a process 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. There is strong encouragement for non-governmental organizations, such as environmental and consumer groups, to actively participate in European standardization.
Many standards in the EU are adopted from international standards bodies such as the International Standards Organization (ISO). The drafting of specific EU standards is handled by three European standards organizations:
Standards are created or modified by experts in Technical Committees or Working Groups. The members of CEN and CENELEC are the national standards bodies of the Member States, which have "mirror committees" that monitor and delegate experts to participate in ongoing European standardization. CEN and CENELEC standards are sold by the individual Member States standards bodies. ETSI is different 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. In addition to the three standards developing organizations, the European Commission plays an important role in standardization through its funding of the participation in the standardization process of small- and medium-sized companies and non-governmental organizations, such as environmental, labor and consumer groups. 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. Mandates– or requests (the Commission requests CEN/CENELEC or ESTI to develop standards) for standards.
Given the EU’s vigorous promotion of its regulatory and standards system as well as its generous funding for its development, the EU’s standards regime is wide and deep - extending well beyond the EU’s political borders to include affiliate members (countries which are hopeful of becoming full members in the future) such as the Western Balkan countries among others. 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.
To view what CEN and CENELEC have in the pipeline for future standardization, it is best to visit their websites. 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 portal links to ongoing activities.
The European Standardization system and strategy was reviewed in 2011 and 2012. The new standards regulation 1025, adopted in November 2012, clarifies the relationship between regulations and standards and confirms the role of the three European standards bodies in developing harmonized standards (EN). The emphasis is also on referencing international standards where possible. For information, communication, and technology (ICT) products, the importance of interoperability standards has been recognized. Through a relatively recent mechanism, a “Platform Committee” reporting to the European Commission will decide which deliverables from fora and consortia might be acceptable for public procurement specifications. The European standards bodies have been encouraged to improve efficiency in terms of delivery and to look for ways to include more societal stakeholders in European standardization. The Joint Initiative on Standardization, launched in 2016 with several action items to improve European standardization, involves a large group of stakeholders who are committed to deliver results by 2019.
Key Link: Standardization Policy
Swedish Standards Institution, SIS
118 80 Stockholm
Sweden
Tel: +46-8-555 520 00
SIS develops or revises over 1,300 Swedish and international standards annually within most business areas, by working closely with the private sector, Swedish authorities, consumer representatives and other stakeholders. 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.
Informationstekniska Standardiseringen, ITS
The Swedish Telecommunication Standardization Organization
Box 1284
164 29 Kista, Sweden
Tel. +46 70 300 9542
Since March 2002, ITS has been recognizing European standards (EN) directly instead of transposing them to Swedish SS standards. All new proposals of standards and changes/adoptions of technical regulations should be determined and adjusted in respect to existing international and European standards. ITS acts as the national standardization body for Sweden at ETSI, European Telecommunication Standards Institute.
SEK Svensk Elstandard
The Swedish Electro-Technical Standards
Box 1284
164 29 Kista, Sweden
Tel. +46 8 444 1400
SEK coordinates the electro-technical standardization through technical committees that directly reflect the work done on the international level at both IEC and CENELEC. The standardization and revision process is open to all Swedish organizations, companies, institutions, and the public sector.
Testing, inspection, and certification\
To sell products in the EU markets 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 several 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 to use EU-wide harmonized standards.
Products manufactured to standards adopted by CEN, CENELC, 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.
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. It is not intended to include detailed technical information on the product, but sufficient information to enable the inspector to trace the product back to the manufacturer or the local contact established in the EU.
Swedish Bodies
RICE – Research Institutes of Sweden
Certification
Box 857
501 15 Borås, Sweden
Tel. +46 10 516 5000
Intertek Semco Certification AB
Box 1103
164 22 Kista, Sweden
Tel. +46 8 750 0333
SWEDAC, Styrelsen for Ackreditering och Teknisk Kontroll
Swedish Board for Accreditation and Conformity Assessment
Box 878,
501 15 Borås, Sweden
Tel: +46-771 990 900
Publication of technical regulations
When it comes to technical regulations Sweden abides by the EU directives and WTO agreements and accordingly reports all proposals to both EU and WTO. The entity responsible for information and notification procedures for new national technical regulations is the National Board of Trade.
All the Swedish proposals and final regulations are listed on the EU data base TRIS, Technical Regulations Information System.
The National Board of Trade
Box 6803
113 86 Stockholm, Sweden
Tel. +46 8 690 4800
Email: Oscar.waglund.soderstrom@kommers.se
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, studies by committees. It also lists the standards reference numbers linked to legislation (Harmonized Standards).
National technical regulations are published on the Commission's website to allow other countries and interested parties to comment.
“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.”
US Embassy Stockholm
Dag Hammarskjölds Väg 31
115 89 Stockholm, Sweden
Tel. +46 8 783 5300
Post Standards Contact: Tuula Ahlström, tuula.ahlstrom@trade.gov
Swedish Standardization Federation
Box 5510
114 85 Stockholm, Sweden
Tel. +46 8 782 0850
Swedish Standards Institution, SIS
118 80 Stockholm.
Sweden
Tel: +46-8-555 520 00
Informationstekniska Standardiseringen, ITS
The Swedish Telecommunication Standardization Organization
Box 1284
16429 Kista, Sweden
Tel. +46 8 444 1424
SEK Svensk Elstandard
The Swedish Electro-Technical Standard
Box 1284
16429 Kista, Sweden
Tel. +46 8 444 1400
SWEDAC, Styrelsen for Ackreditering och Teknisk Kontroll
Swedish Board for Accreditation and Conformity Assessment
Box 878
501 15 Borås, Sweden
Tel: +46-33-177 700
Rise
Box 857
501 15 Borås, Sweden
Tel. +46 10 516 5000
Intertek Semco Certification AB
Box 1103
164 22 Kista, Sweden
Tel. +46 8 750 0333
The National Board of Trade
Box 6803
113 86 Stockholm, Sweden
Tel. +46 8 690 4800
Livsmedelsverket (National Food Administration)
Box 622
751 26 Uppsala, Sweden
Tel: +46 18 17 55 00
Läkemedelsverket (Medical Products Agency)
Box 26
751 03 Uppsala, Sweden
Tel: +46 18 17 46 00
Kemi (Swedish Chemicals Agency)
Box 2
172 13 Sundbyberg, Sweden
Tel: +46 8 519 41 100
U.S. Mission to the EU
Rebecca Balogh, Standards Attaché
Rebecca.balogh@trade.gov
Tel: +32 2 811 5034
National Institute of Standard & Technology
Gordon Gillerman Standards Coordination Office
100 Bureau Dr.
Mail Stop 2100
Gaithersburg, Maryland 20899
Tel: (301) 975-4000
CEN- European Committee for Standardization
Avenue Marnix 17
B – 1000 Brussels, Belgium
Tel: +32.2.550.08.11
Fax: +32.2.550.08.19
CENELES- European Committee for Electrotechnical Standardization
Avenue Marnix 17
B – 1000 Brussels, Belgium
Tel: +32.2.519.68.71
Fax: +32.2.519.69.15
ETSI- European Telecommunications Standards Institute
Route des Lucioles 650
Sophia Antipolis
F-06560 Valbonne, France
Tel: +33.4.92.94.42.00
Fax: +33.4.93.65.47.16
SBS- Small Business Standards
4, Rue Jacques de Lalaing
B-1040 Brussels, Belgium
Tel: +32.2.285.07.27
Fax : +32-2/230.78.61
ANEC- European Association for the Co-ordination of Consumer Representation in Standardization
Avenue de Tervuren 32, Box 27
B – 1040 Brussels, Belgium
Tel: +32.2.743.24.70
Fax: +32.2.706.54.30
ECOS- European Environmental Citizens Organization for Standardization
Rue d’Edimbourg 26
B – 1050 Brussels, Belgium
Tel: +32.2.894.46.68
Fax: +32.2.894.46.10
EOTA- European Organization for Technical Assessment
Avenue des Arts 40
B – 1040 Brussels, Belgium
Tel: +32.2.502.69.00
Fax: +32.2.502.38.14