Last checked: 20/08/2020

Product compliance

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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

A manufacturer is an individual or legal person (An individual, company, or other entity which has legal rights and is subject to obligations) 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:

As a manufacturer, you must ensure that your products conform to EU law. If they do not, you may not trade them on the EU market. If your products cease to comply with EU law, you must withdraw or recall them. In the event that the products you have placed on the EU market (In this case, the 27 EU member states, UK, Iceland, Lichtenstein, Norway and Turkey) turn out to pose a risk to health and safety or the environment, you must inform the local national authority and publish this information on the Product Safety Business Alert Gateway.

Authorised representatives

Manufacturers, whether they are based inside or outside the EU,​ may appoint an authorised representative in the EU (In this case, the 27 EU member states, UK, Iceland, Lichtenstein, Norway and Turkey) 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 (An individual, company, or other entity which has legal rights and is subject to obligations) 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:

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.

As an importer, you must ensure that the products you import conform to EU law. If they do not, you cannot import them. If you have already imported them, you must withdraw or recall them. In the event that the products you have placed on the EU market turn out to pose a risk to health and safety or to the environment, you must inform your national authority and publish this information on the Product Safety Business Alert Gateway.

A distributor is an individual or legal person (An individual, company, or other entity which has legal rights and is subject to obligations) 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:

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:

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