Product compliance

Before you can begin selling a product in an EU country, it must comply with the rules that apply in that country and throughout the EU. Once the product has been approved for sale in one country, it can then in principle be sold anywhere in the EU. In practice, individual EU countries do retain the right, in certain cases, to restrict the access to their market of products already sold in another EU country.

Different rules must be followed at each step of the process of bringing a product to market: planning, manufacturing, importing (for products manufactured outside the EU), distribution and the final sale to consumers or end-users. Many potential actors are involved.

Explore the interactive content below to find out what each actor does and what their EU‑related obligations are.

Product rules for different business profiles

• Manufacturers or the authorised representatives
• Importers
• Distributors
• Warehouses or fulfilment centres
• Intermediary online service providers

Manufacturers

A manufacturer is an individual or legal person who makes a product (or has a product designed or made) and then places it on the market under its own name or trade mark.

As a manufacturer, your obligations are the same whether you are based inside or outside the EU. From the design stage onward, you must be aware of the rules and standards that apply to your product. You must:

• identify the requirements that apply to your product, EU‑wide and in the country in which you wish to sell it
• check if your product requires a CE marking
• carry out the applicable conformity assessment
• check whether harmonised standards exist for your product
• draw up any required technical documentation (product description, intended use, design, manufacture, operation, etc.)
• draw up the EU declaration of conformity
• draft instructions and safety information regarding the product, in a language easily understood by consumers and other end-users
• satisfy any traceability requirements:
  • preserve the technical documentation and the EU declaration of conformity (for 10 years after the product is placed on the market or for the period specified for that product under EU law)
  • give the product a type, batch or serial number for identification
  • indicate your name, registered trade name and a postal address on the product itself, its packaging or in separate documentation
• affix relevant labels and markings
• if your product is mass‑produced, ensure that each step in the production process guarantees that the product complies with the relevant legislation

Authorised representatives

Manufacturers, whether they are based inside or outside the EU, may appoint an authorised representative in the EU to carry out certain tasks on their behalf, including cooperating with the national market‑surveillance authority and providing them with the documentation required to demonstrate a product's conformity (examples: the EU declaration of conformity and technical documentation).

An importer is an individual or legal person established in the EU who places a product from a non‑EU country on the EU market. As an importer, you must ensure that the manufacturer has fulfilled its obligations regarding the products that you import.

Before placing a product on the market, you must ensure that:

• the manufacturer has carried out the appropriate conformity assessment procedure; if the product has already been placed on the market, corrective actions should be taken, such as bringing the product into compliance, recalling or withdrawing it
• the manufacturer has drawn up the technical documentation, affixed the relevant labels and marking (example: CE marking) and fulfilled their traceability obligations (manufacturer's contact information, display of a type, batch or a serial number on the product for identification purposes)
• the product is accompanied by the relevant instructions and safety information (if required), in a language easily understood by consumers and other end-users (according to the rules of the EU country into which it is imported)
• the product, packaging or accompanying documentation is clearly marked with your name, registered trade name or trade mark and contact address

Be aware of the detailed obligations for manufacturers: as an importer, you have to verify whether your imports comply.

If you already sell goods in one EU country and want to sell them in another, your business can benefit from submitting a declaration of mutual recognition.

A distributor is an individual or legal person in the supply chain who makes a product available on the EU market that they have acquired from a supplier, such as a manufacturer, an importer or another distributor. Distributors include "retailers", who supply products to end‑users, and "wholesalers", who supply products to retailers.

As a distributor, you should ensure the product is in conformity with EU law when placed on the market. If the rules change after the product has been placed on the market, you are not required to check whether it is still compliant.

You also have to know:

• which products must bear the CE marking and/or other mandatory labels
• what information has to accompany products, such as the technical documentation and EU conformity declaration
• the language requirements for labelling, user instructions or other accompanying documents
• what signs would indicate that products are not compliant

You must be able to demonstrate to the national market surveillance authority upon request that you have checked to ensure the product supplier (the manufacturer, importer or another distributor) has followed all the relevant rules. You must also be able to provide the identity of the manufacturer or authorised representative, in order to help the market surveillance authority obtain the EU conformity declaration, the technical documentation and other relevant documents.

If you already sell goods in one EU country and want to sell them in another, your business can benefit from submitting a declaration of mutual recognition.

Warehouse or fulfilment service providers offer services such as storing products sold online and delivering them to distributors.

A provider who also offers services such as packaging products, delivering them to customers and/or handling returns might be considered a distributor and must meet the corresponding obligations.

Go to obligations for distributors.

Intermediaries providing online services engage in hosting activities, including storing information provided by end‑users of services offered via webshops, marketplaces or platforms.

As an online service provider, you are not obliged to verify the conformity/compliance of products sold on your website or platform. However, national authorities can instruct you to stop selling a product or to remove or alter elements related to it, such as a picture or description.

See also:

• Ecodesign requirements