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Selling Products with a CE Mark into the EU

From 16 July 2021, any CE-marked products that are sold into the EU, will have to have an EU established economic operator listed on the product or packaging. The economic operator can be a manufacturer, importer, authorized representative or fulfilment service provider based in the EU.

This is due to the new EU regulations on market surveillance together with the Guidelines for its practical implementation. To ensure you're compliant with the new regulations, follow these steps:

  1. Check if you are selling CE marked products into the EU. You can see examples of products that carry the CE mark in our FAQ.
  2. Verify the products are meant for the EU market and comply with the EU legislation. If in doubt, contact the manufacturer.
  3. If the products are compliant, check whether you see information of the EU manufacturer or EU importer on the products. If there is an EU manufacturer or importer, they are the economic operator in Europe.
  4. If there is no EU manufacturer or importer, check with the non-EU manufacturer to see if they have an authorized representative. If there is one, obtain the name and contact details (including the postal address) of the authorized representative and ensure that the information is indicated on the product or its packaging. 
    1. If the non-EU manufacturer has not appointed an authorized representative in the EU, work with the manufacturer to appoint one. The authorized representative will need a mandate signed by the manufacturer as well as obtaining and keeping the certificate of conformity/performance and other technical documentation from the manufacturer
    2. Alternatively, you can use a fulfilment service provider in the EU

      If you can't appoint or obtain information of an economic operator for the CE marked products you intend to sell to the EU on or before 16 July 2021, you will not be allowed to sell the product to the EU until an economic operator in the EU is arranged for.

Frequently Asked Questions

What is an economic operator?

Four types of economic operators are accepted under the new regulations:

  1. Manufacturer in the EU
  2. Importer in the EU
  3. Authorized Representative in the EU
  4. A fulfilment service provider in the EU

What does an economic operator do?

An economic operator has to be established in the EU. Their key tasks include:

  1. Verifying that the declaration of conformity / performance for a product has been drawn up and kept pursuant to legal requirements.
  2. Verifying that the technical documentation of the product has been drawn up and provided to the market surveillance authorities on request.
  3. Cooperating with relevant authorities to provide any other information to demonstrate product conformity as required.
    1. Where an economic operator has reason to believe that a product is not compliant or poses a health and safety risk to the public, it has to inform the authorities and take corrective action, whether by itself or by asking the manufacturer to do so.

Which products do the regulations and guidelines apply to?

They apply to a wide range of products which are required to bear CE marking. Examples include: 

  1. construction products
  2. personal protective
  3. equipment appliances
  4. burning gaseous fuels
  5. products subject to the Directive relating to noise emissions by equipment for use outdoors machinery
  6. toys
  7. products subject to ecodesign requirements
  8. products subject to restrictions on the use of certain hazardous substances in electrical and electronic equipment
  9. pyrotechnic articles
  10. recreational craft and personal watercraft
  11. simple pressure vessels
  12. products subject to the Directive on electromagnetic compatibility
  13. non-automatic weighing instruments
  14. measuring instruments
  15. equipment and protective systems intended for use in potentially explosive atmospheres
  16. products subject to the Low Voltage Directive
  17. radio equipment
  18. pressure equipment

Products requiring CE marking are covered by the EU New Approach Directive. Find more information on EU and UK Government websites:

  1. New legislative framework
  2. CE marking (europa.eu)
  3. CE marking (gov.uk)

What is an EU fulfilment service provider?

Fulfilment service providers in the EU are specialist companies or persons in the EU which provide at least two or more of the following services:

  1. warehousing
  2. packaging
  3. addressing 
  4. dispatching

    It does not include carriers or logistics service providers which only handle shipment or movement of goods.

    If you want to use a fulfilment service provider in the EU, you can work with the manufacturer to provide them with relevant documents. If the fulfilment service provider accepts the documents and your goods, it will become an economic operator and you can then indicate their name or contact information (including postal address) on the product or its packaging. However, some fulfilment service providers may ask for an authorized representative of your products instead. In which case, you would still need to work with the non-EU manufacturer to appoint an authorized representative in the EU.