Product safety and the role of the authorised representative
Are you the authorised representative of a manufacturer in the EU? And does the manufacturer put products (non-food) on the market with your help? Then you must meet the requirements for product safety.
What is an authorised representative?
An authorised representative (AR) is a company or person established in the EU who takes care of certain administrative tasks on behalf of a manufacturer. Manufacturers must ensure their products are safe. Otherwise, a manufacturer may not market the product.
The manufacturer can instruct an authorised representative to carry out administrative tasks. For example, keeping the technical file that is required to comply with the EU legislation on product safety, and supplying information to the supervising authorities. The manufacturer remains responsible for the product’s safety.
If a manufacturer who is not established in the EU wants to sell a product in the EU, they can appoint an authorised representative (AR) in the EU. Manufacturers who are established in the EU, for example with a branch office, can also appoint an AR.
An importer or distributor can also be an authorised representative
An importer or distributor can also perform the tasks of an authorised representative. This is only allowed if the manufacturer gives you written instructions to do so. In this case an importer or distributor must also comply with the rules for importers or distributors.
Required duties of an AR
An authorised representative is only allowed to perform the administrative tasks the manufacturer assigned to them in writing beforehand. The manufacturer remains responsible for how the product is made (the manufacturing process) and for the product’s safety.
As an AR under the General Product Safety Regulation (GPSR), you have at least the following duties:
- You have to provide the information and documents a supervising authority asks for. These must show that the product is safe. You do this in an official language the authority understands.
- You must report the measures taken to eliminate product risks to the Netherlands Food and Consumer Product Safety Authority (NVWA) or another supervising authority. You do this via the EU’s Safety Business Gateway. You must do so if the manufacturer has not passed on this information.
- You must help the NVWA or another supervising authority remove product risks if they ask you to.
Have you found that a product is dangerous? Tell the manufacturer immediately. Then also report it via the Safety Business Gateway. Give information about the risks, the number of products, and the steps you have taken.
A manufacturer can also authorise you to carry out additional administrative tasks. For example, affixing CE marking or drawing up an EU declaration of conformity.
Identification and contact details on product (traceability)
Your product must be traceable in order to track and recall it, for example. These rules apply:
- There is an identifier on the product. The manufacturer must put a type number, batch number, serial number or other identifier on the product. Consumers must be able to see and read this easily. If that is not possible, for example because the product is very small, the identifier must accompany the product: on the packaging or in a document.
- The manufacturer must put their name or trade name, and their postal and electronic address on the product. If that is not possible, these details must be on the packaging or in a document with the product. Is the manufacturer located outside the EU? Then the contact details of the person or company in the EU responsible for the product must also be stated.
Stricter rules for medical devices
Are the products medical devices from a manufacturer outside the European Economic Area (EEA)? Then, as an AR, you have more responsibilities. For example, you must check that the manufacturer has prepared the EU declaration of conformity and technical documentation. You must keep these documents for at least 10 years. For implantable devices, this is at least 15 years.
Hire specialist help
The information on this page gives a general overview of EU product safety legislation. It applies to the European Economic Area, and in some cases also to Switzerland and Türkiye. Your product may have to meet additional requirements in different countries. Check whether your product must meet these additional rules before you put it on the market. You can hire a specialist to help you.
Amendments
The information on this page can change due to:
- More parties liable for defective productsEffective date: not yet known