European Union - CE Marking and EU StandardsEuropean Union-CE Marking/Standards
Prior to exporting, U.S. manufacturers have to consider certification for the EU market. Certification is about conformity assessment in order to declare compliance with EU regulatory requirements. For the majority of exported products, compliance is visibly testified by the manufacturer through the use of CE marking. Use of standards is part of the process.
Bearing in mind that testing and certification for the U.S. market are not sufficient for exporting to the EU, manufacturers will need to start from scratch in order to determine what it takes to comply with EU requirements. Since EU legislation harmonizes mandatory requirements for product safety throughout the European Union, a manufacturer only needs to go through the process once and can then export to all 28 EU member states (and beyond). With appropriate certification, goods travel freely within the borders of the Single Market.
Where to start? That is where we come into the picture: the Standards Team (Attaché and Specialist) at CSEU offers guidance on the road to regulatory compliance. As a first step, we recommend the websites listed below for an introduction to the range of legislation and standards that may be applicable to your product(s). Contact us for in-depth counseling on EU standards, product testing, and certification requirements.
CE Marking Step-by-Step
1. Read general guidance on standards/labeling/certification in the EU Country Commercial Guide
2. Find the applicable directive (legislation)
3. Determine the essential requirements in the directive (usually Annex I)
4. Note the harmonized European EN standards
5. Choose the appropriate conformity assessment module as described in the directive’s annex
6. Locate Notified Bodies (accredited test laboratories) – if required!
7. Create a Technical File and Declaration of Conformity and apply CE marking
8. Consider working with consultants
http://www.export.gov/cemark/eg_main_017270.asp or contact office.brusselsEC@trade.gov
Frequently Asked Questions:
Where do I find EU product legislation?
Under industry sectors on https://ec.europa.eu/growth/sectors_en
Where can I find European (EN) standards? https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en
In the event that I need the services of a test laboratory – EU notified body, U.S. based subcontractor or conformity assessment body - where do I obtain a list?
Want to understand CE marking in more detail? CE marking guidance booklet
CEN, European Committee for Standardization
CENELEC, European Committee for Electrotechnical Standardization
ETSI, European Telecommunications Standards Institute
ANSI, American National Standards Institute (to search for EN standards in U.S.)
European Union law portal
Standards for Trade
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 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 legislation and standards created under the so-called New Approach are harmonized across the Member States and European Economic Area countries to allow for the free flow of goods. New approach laws require the use by the manufacturer of 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 NLF concepts, For 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.
The establishment of harmonized EU rules and standards in the food sector has been ongoing for several decades, and in January 2002 the EU publicized a general food law establishing the general principles of EU food law. 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: FAIRS Export Certificate Report
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, labor 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. The Commission requests CEN/CENELEC or ESTI to develop standards - see Mandates.
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 a number of action items to improve European standardization, involves a large group of stakeholders who are committed to deliver results by 2019.
Key Link: Standardization Policy
Testing, Inspection and Certification
Conformity Assessment is a mandatory step for the manufacturer in the process of complying with specific EU harmonized 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. Conformity assessment bodies in individual Member States are listed in the New Approach Notification and Designated Organizations (NANDO) information system.
Key Link: NANDO
To promote market acceptance of the final product, there are a number of voluntary conformity assessment programs. CEN and Cenelec’s certification system is known as the Keymark. ETSI does not offer conformity assessment services.
To sell products in the EU market of 28 Member States as well as in EEA/EFTA (Norway, Liechtenstein Iceland, Switzerland) and Turkey, 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 essential requirements of EU harmonized legislation. 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 and EFTA. 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 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. Compliance with and enforcement of product harmonization legislation and mutual recognition of products was further improved in 2019.
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.
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.
Publication of technical regulations
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, and studies by committees, among others. It also lists the standards reference numbers linked to legislation (Harmonized Standards).
Proposed National technical regulations are published on the Commission's website to allow other countries and interested parties to comment.
National Institute of Standards and Technology’s (NIST) Notify U.S. Service
Member countries of the World Trade Organization (WTO) are required under the Agreement on Technical Barriers to Trade (TBT Agreement) to report to the WTO all proposed technical regulations that could affect trade with other Member countries. The Notify U.S. Service is a free, web-based e-mail subscription service that offers an opportunity to review and comment on proposed foreign technical regulations that can affect access to international markets. Register online at Internet URL: Notify U.S.
U.S. Mission to the EU
Tel: +32 2 811 42 44
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
Rue de la Science 23
B – 1040 Brussels, Belgium
CENELEC- European Committee for Electrotechnical Standardization
Rue de la Science 23
B – 1040 Brussels, Belgium
ETSI- European Telecommunications Standards Institute
Route des Lucioles 650
F-06560 Valbonne France
SBS- Small Business Standards
Rue Jacques de Lalaing 4
Fax : +32-2/230.78.61
ANEC- European Association for the Co-ordination of Consumer Representation in Standardization
Avenue de Tervueren 32, Box 27
B – 1040 Brussels, Belgium
ECOS- European Environmental Citizens Organization for Standardization
Rue d’Edimbourg 26
B – 1050 Brussels, Belgium
EOTA- European Organization for Technical Assessment
Avenue des Arts 40
B – 1040 Brussels, Belgium
European Union 28 Market Access Trade Development and Promotion