United Kingdom - Trade Standards Trade Standards
Overview
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 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. 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. The Britsh Standards Institute is regularly active group that represents the UK in proposing new work in ISO and IEC.
To improve the Internal Market for goods and strengthen the conditions for placing a wide range of products on the EU Market, the New Legislative Framework was adopted in 2008. It is a package of measures that aim to improve market surveillance and boost the quality of conformity assessments. It also clarifies the use of CE marking and creates a toolbox of measures for use in product legislation.
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.
The Regulation (EU) No 1169/2011 on the provision of food information to consumers entered into application on 13 December 2014. The Regulation provides consumer protection in relation to food information, taking into account the differences in the perception of consumers and their information needs whilst ensuring the smooth functioning of the internal market. Foreign Agricultural Service’s office in the U.S. Mission to the European Union represents the interests of U.S. farmers and the U.S. food and agricultural sector in the European Union. Its main mission is to improve market access for U.S. products and provide information to U.S. exporters on how to comply with EU rules. On its website you will find information on EU regulatory actions that may affect U.S. agricultural exports, trade policy and commodity analysis, how the EU works and much more.
Standards
Standards are technical specifications defining requirements for products, production processes, services or test-methods. These specifications are voluntary. They are developed by industry and market actors following some basic principles such as consensus, openness, transparency and non-discrimination. Standards ensure interoperability and safety, reduce costs and facilitate companies' integration in the value chain and trade.
European Standards are under the responsibility of the European Standardisation Organisations (CEN, CENELEC, ETSI) and can be used to support EU legislation and policies.
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 EU 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 and consumer groups. The Commission also provides money to the standards bodies when it mandates standards development to the European Standards Organization for harmonized standards that will be linked to EU technical legislation.
To know 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 Policy has played a leading role in creating the EU Single Market. Standards support market-based competition and help ensure the interoperability of complementary products and services. They reduce costs, improve safety, and enhance competition. Due to their role in protecting health, safety, security, and the environment, standards are important to the public. The EU has an active standardization policy that promotes standards as a way to better regulation and enhance the competitiveness of European industry.
Testing, Inspection and Certification
Conformity Assessment
Conformity Assessment is a mandatory step for the manufacturer in the process of complying with specific EU legislation. The purpose of conformity assessment is to ensure consistency of compliance during all stages, from design to production, to facilitate acceptance of the final product. EU product legislation gives manufacturers some choice regarding conformity assessment, depending on the level of risk involved in the use of their product. These range from self-certification, type examination and production quality control system, to full quality assurance system.
To promote market acceptance of the final product, there are several voluntary conformity assessment programs. CEN’s certification system is known as the Keymark. Neither CENELEC nor ETSI offer conformity assessment services.
Product Certification
To sell products in the EU market of 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 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. The CE marking process is very complex and this section attempts to provide some background and clarification.
Products manufactured to standards adopted by CEN, CENELEC 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. 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. As market surveillance was found lacking, the EU adopted the New Legislative Framework, which went into force in 2010. As mentioned before, this framework is like a blueprint for all CE marking legislation, harmonizing definitions, responsibilities, European accreditation and market surveillance.
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 local contact 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.
Accreditation
Independent test and certification laboratories, known as notified bodies, have been officially accredited by competent national authorities to test and certify to EU requirements.
"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 to appropriate EN and ISO/IEC standards.
UKAS is the UK’s National Accreditation Body, responsible for determining, in the public interest, the technical competence and integrity of organizations such as those offering testing, calibration and certification services.
Publication of Technical Regulations
The Official Journal 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, and more. It also lists the standards reference numbers linked to EU legislation.
The (EU) 2015/1535 procedure aims to prevent creating barriers in the internal market before they materialize. Member States notify their legislative projects regarding products and Information Society services to the Commission which analyses these projects in the light of EU legislation. Member States participate on the equal foot with the Commission in this procedure and they can also issue their opinions on the notified drafts.
The Technical Regulation Information System helps you to be informed about new draft technical regulations, allows you to participate in the 2015/1535 procedure and is also a tool of dialogue between the Commission that allows 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. 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.
Contact Information
U.S. Commercial Service to the EU
Standards Attaché
Please contact Rebecca Balogh :
rebecca.balogh@trade.gov
Tel: +32 2 811 5034
National Institute of Standard & Technology (NIST)
Gordon Gillerman Standards Coordination Office
NIST, 100 Bureau Drive, Mail Stop 2100
Gaithersburg, MD 20899-2100
sco@nist.gov
Tel: 301.975.4000
CEN- European Committee for Standardization
CEN-CENELEC Management Centre
Rue de la Science 23
B - 1040 Brussels, Belgium
Tel: + 32 2 550 08 11
http://www.cen.eu/
CENELEC- European Committee for Electrotechnical Standardization
Avenue Marnix 17
B – 1000 Brussels, Belgium
Tel: 32.2.519.68.71
http://www.cenelec.eu/
ETSI- European Telecommunications Standards Insitute
Route des Lucioles 650
Sophia Antipolis
F-06560 Valbonne France
Tel: 33.4.92.94.42.00
http://www.etsi.org/
SBS- Small Business Standards
4, Rue Jacques de Lalaing
B-1040 Brussels
Tel: 32.2.285.07.27
http://sbs-sme.eu/
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
https://www.anec.eu/
ECOS- European Environmental Citizens Organization for Standardization
Rue d’Edimbourg 26
B – 1050 Brussels, Belgium
Tel: 32.2.894.46.68
http://ecostandard.org/
EOTA- European Organization for Technical Assessment
Avenue des Arts 40
B – 1040 Brussels, Belgium
Tel: 32.2.502.69.00
https://www.eota.eu
British Standards Institution
389 Chiswick High Road
London
W4 4AL
United Kingdom
Tel: +44 208 996 90 00
https://www.bsigroup.com/en-GB