Automotive

Voluntary Marks and Labels

Not all products must have the CE Mark.  Only products that fall under the regulations or directives for the categories above have the CE Mark.  It is forbidden to use the CE mark on other products, such as cosmetics or chemicals.  The CE mark is a declaration by the manufacturer that the product meets all EU legal requirements and does not indicate that authorities have approved the product.  CE marked products can be sold in all EU countries and the European Economic Area.  Exporters should also note that CE markings are routinely falsified by manufacturers outside of the European Union.

The use of language on labels has been the subject of a Commission Communication that encourages multilingual information, while preserving the right of Member States to require the use of the language of the country of consumption.

For more detailed information on EU labeling and marketing requirements, refer to “Doing Business in the European Union:  2021 Country Commercial Guide for U.S. Companies,” available from the U.S. Mission to the EU.

EU Legislation and CE Marking

Many products require the CE Mark before they can be sold in the EU.  The CE Mark indicates 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 consider to be “harmonized,” meaning 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 notify 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 also 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 EU 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:

Starting from 16 July 2021, all CE marked products will need to have an EU address on the label.  This also applies to products sold online.  The name and address must appear on the product or the product’s packaging so that customs and market surveillance authorities can have a contact person in case the product is suspected to present a risk.  If an importer or distributor cannot fulfill that role, an exporter will have to appoint an Authorized Representative in the European Union or use a shipping platform to play that role.  The Authorized Representative is responsible 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.  In March 2021, the European Commission published guidelines under Article 4 of the Regulation (Regulation (EU) 2019/1020)).

For more information on obtaining a CE Mark, please contact the U.S. Mission to the European Union.

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.

Please note that currently 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. 

Key Links:  Regulation on market surveillance and compliance of products

List of National Authorities Responsible for Product Safety

Updated Medical Device Regulations

The EU’s revised Medical Device Regulation went into effect in May 2021.  The revised In Vitro Diagnostic Device Regulation is set to go into effect in May 2022 (although an extension is being sought on the grounds that the European Union has not named a sufficient number of notified bodies to meet the demand for certifications caused by this regulation).  In addition, restrictions put into place due to the COVID-19 pandemic have prevented many audits from taking place to certify device requirements under the Medical Device Regulation.  The European Commission has published an official notice allowing notified bodies to conduct initial audits of medical device quality management systems virtually, which includes audits of manufacturers’ suppliers and subcontractors to verify their manufacturing and other processes, but this applies to the Medical Device Regulation and not the In Vitro Diagnostic Device Regulation.

All medical devices marketed in the EU must bear the CE mark. For more information on the regulations, please visit: https://ec.europa.eu/health/md_sector/overview_en.

Updated Machinery Regulation

In April 2021, the Commission released a Proposed Regulation for the Safety of Machinery to replace the current Machine Safety Directive, which has been in effect since 2006.  Machinery in the European Union is broadly defined as consisting of an assembly of components, at least one of which moves, for a specific application.  The drive system of machinery is powered by energy, other than human or animal effort.  The new Machine Safety Regulation could be adopted sometime between 2022 and 2023.  One of the features of the new regulation is that it discusses the place of, and safety requirements for, artificial intelligence in machinery.