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EU Standards and CE Marking

Prior to exporting, U.S. manufacturers have to consider certification for the EU market.   Certification is about conformity assessment (testing and certification) in order to declare compliance with EU regulatory requirements.    For the majority of exported products, compliance is visibly testified by 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 27 EU member states.   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 offer 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 or presented in flow charts in the CE marking guidance booklet

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://business.usa.gov/export/EU-Standards-and-CE-Marking

http://business.usa.gov/export/New-EU-REACH-Program/Business-Service-Providers

Frequently Asked Questions:

Where do I find EU product legislation?
Under industry sectors on http://ec.europa.eu/enterprise/sectors_en.htm

Where can I find European standards? http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/whatsnew.html

http://www.cenelec.eu/

http://www.etsi.org/WebSite/homepage.aspx

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? http://ec.europa.eu/enterprise/newapproach/nando/

http://gsi.nist.gov/global/index.cfm/L1-4/L2-16/L3-85/A-90

http://business.usa.gov/export/EU-Standards-and-CE-Marking

Other Resources

CENELEC, European Committee for Electrotechnical Standardization 
ETSI
, European Telecommunications Standards Institute 
CEN
, European Committee for Standardization
ANSI
, American National Standards Institute
European co-operation for Accreditation

European Union law portal