Many products require the CE Mark before they can be sold in the EU (see page 48). The CE Mark indicates that a product has been assessed by the manufacturer and meets the essential health and safety requirements enshrined in what are commonly considered the CE Mark Directives and Regulations. These directive and regulations are legislative acts adopted by the EU as a whole and are considered to be “harmonized”, which means that they apply across all EU member states and are mandatory. (Note however member states can have additional requirements in some cases). In order to attest that a product fulfills these harmonized EU essential health and safety requirements and qualifies for the CE Mark, manufacturers must create a technical file which documents how the product meets the directive or regulation requirements (generally through testing, design, and risk assessments). Each CE Mark directive or regulation determines how hazardous the product category is considered. For some less hazardous products, the testing and risk assessment (also called conformity assessment) may be done by the manufacturer themselves. In this case the manufacturer would assemble the “technical file” which will document how the product meets the essential health and safety requirements of the specific CE Mark directive or regulation. The manufacturer then issues themselves a declaration of conformity (DOC). It is this self-DOC which allows them to then affix the CE Mark to their product. The DOC is self-declared on the product and market surveillance organizations in the EU can and do call upon the manufacturer to produce the technical file that backs up the DOC. Where the product is considered more hazardous, third party testing is mandated, and certificates of conformity are issued by an EU approved third party testing organization called a Notified Body. The Nando database should be searched for a notified body which can certify specific products. The Blue Guide is an official, but non-legal EU document, which has an exhaustive discussion of the process and background to understanding compliance with harmonized legislation. Note that a product cannot be retroactively given a CE Mark DOC whether self-determined or determined through third party testing. The product must be CE Marked before being put or “placed” on the EU market. There is no official process to remedy the lack of a CE Mark once a product enters the EU.
Bear in mind that testing and certification to U.S. standards for the U.S. market is generally not sufficient for exporting to the EU. However, since EU legislation harmonizes mandatory requirements for product safety of CE marked products throughout the European Union, a manufacturer only needs to go through the process of determining compliance 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 products are not regulated by specific EU technical legislation (whether CE Marked or not), they are always subject to the EU’s General Product Safety Directive as well as to possible additional national requirements.
CE Marking Step-by-Step
1. Find the applicable directive (legislation)
2. Determine the essential requirements in the directive (usually Annex I)
3. Note the harmonized European EN standards
4. Choose the appropriate conformity assessment module as described in the directive’s annexes
5. Locate Notified Bodies (accredited test laboratories) – if required!
6. Create a Technical File and Declaration of Conformity and apply CE marking
Contact the U.S. Commercial Service at the U.S. Mission to the EU for more information or email office.brusslesEC@trade.gov
For an overview of EU product safety
Consider working with consultants
New requirements for CE marked products:
Going into force on July 16, 2021, the new EU Regulation on Market Surveillance and Product compliance (Regulation (EU) 2019/1020) (commonly called the “Goods Package”) will bring important changes to market surveillance in the EU for more than 70 EU product laws and for product compliance for 20 categories of CE marked products. Some of these changes include reinforced controls at the border, new responsibilities for shipping platforms, new requirements for products sold online, and, most importantly for U.S. exporters, the mandatory appointment of a Responsible Person/Economic Operator based in the EU for certain products covered under Article 4 of the directive. The product categories affected under Article 4 of this directive include most of the CE Marked products. There is no small business, minimum value, or quantity exception for third country products placed on the EU market. Therefore, depending on the guidance to be released, a U.S. exporter would need to have a designated Responsible Person/Economic Operator based in the EU for the sale of even one item into the EU.
The mandatory Responsible Person/Economic Operator will be responsible, at a minimum, for ensuring the availability of the conformity documentation, cooperating with market surveillance authorities, and informing authorities when they have reasons to believe that a product presents a risk. Guidance for the application of Article 4 of the directive is expected to be published in late 2020.
The following CE marked product categories may be placed on the EU market only if a Responsible Person/Economic Operator established in the EU is appointed:
Construction products, Personal Protective Equipment, Machinery, Electrical and Electronic Equipment (‘ROHS, EMC, Low Voltage’), Toys, recreational crafts, radio equipment, energy-related products (‘Ecodesign’), gas appliances, outdoor equipment (‘outdoor noise’), equipment for use in potentially explosive atmospheres (‘ATEX’), pressure equipment, simple pressure vessels, pyrotechnic articles, measuring equipment, non-automatic weighing instruments.
The economic operator or ‘EU Responsible Person’ can be a manufacturer in the EU, the EU importer, an authorized representative appointed by the Manufacturer, or a fulfilment service provider. Whichever the option chosen, the name and address of this EU-based representative must appear on the product or packaging so that customs or market surveillance authorities can have a contact person in the EU in case the product presents a risk. This also applies to products sold on-line. Guidelines on the new regulation are expected in the fall 2020.
EU market surveillance authorities are under no legal requirement to notify the U.S. manufacturer or exporter when their product is considered a potential risk. They are required only to notify the EU responsible person or economic operator. Timing to respond to a market surveillance inquiry typically starts when the EU responsible person/economic operator is notified. Thus, it is important that any agreement with the U.S. exporter’s chosen EU responsible person/economic operator specify the timeframe for notifying the U.S. exporter. Failure to respond in a timely manner can result in a product notification to the EU’s product recall system which would preclude that product from the EU market.
Regulation on market surveillance and compliance of products
List of National Authorities Responsible for Product Safety
Safety Gate
Frequently Asked Questions:
Where do I find EU product legislation?
Under industry sectors on http://ec.europa.eu/growth/sectors_en
Where can I find European (EN) standards? http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en
https://standards.cen.eu/dyn/www/f?p=CENWEB:105::RESET::::
https://www.cenelec.eu/dyn/www/f?p=104:107:0::::FSP_LANG_ID:25
https://www.etsi.org/standards/get-standards#Pre-defined%20Collections
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/growth/tools-databases/nando/
https://www.nist.gov/standardsgov/lists-recognized-us-cabs\
https://www.trade.gov/ce-marking
Want to understand CE marking in more detail? CE marking guidance booklet
Other Resources
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 Accreditation
European Union law portal