All products placed on the EU market must be safe and comply with the applicable legal rules. Different economic operators in the supply chain have very clearly defined responsibilities, so it is important for all economic operators to understand the following definitions:
- Manufacturer – means any natural or legal person who manufactures a product or has a product designed or manufactured and markets that product under its own name or trademark.
- Importer – means any natural or legal person established within the European Union who places a product from a third country such as China on the European market.
- Distributor – means any natural of legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.
- Fulfilment service provider – means any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services (as defined in point 1 of Article 2 of Directive 97/67/EC), parcel delivery services (as defined in point 2 of Article 2 of Regulation (EU) 2018/644), and any other postal services or freight transport services.
- Authorised representative – means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer.
EU legislation provides a clear and comprehensive list of obligations for each of the economic operators involved in the process of importing products to the European Union.
Manufacturer
The manufacturer takes on primary responsibility for ensuring products are safe and compliant, and they have an obligation to:
- Only produce and place on the market safe products and document them accordingly. For some product categories – such as toys, electrical products and personal protective equipment – this will require compiling technical documentation, including an EU declaration of conformity, which evidence that the conformity assessment has been carried out.
- Ensure correct product labelling, such as traceability information and, where appropriate, CE marking)
- Monitor the safety of their products, including through product testing, investigating consumer complaints, etc.
- Notify relevant national market surveillance authorities about the corrective actions they intend to take, if they suspect having placed an unsafe product on the EU market. For such exchanges, the manufacturer can use the Product Safety Business Alert Gateway, which is a tool enabling economic operators to directly inform relevant national authorities about dangerous products they are responsible for.
Importer
The importer has a responsibility to ensure that non-EU manufacturers have fulfilled their legal obligations in order to ensure products entering the EU marketplace are safe and compliant. Importers have an obligation to:
- Verify the manufacturer outside the EU has taken all the necessary steps to allow the product to be placed on the EU market. It is important for an importer to understand the legislation and standards that apply to different products.
- Check all necessary documentation and ensure that it is available upon request. For certain products that require CE marking such as toys and electrical products, this will include technical documentation and the declaration of conformity.
- Monitor the safety of imported products, including through product testing, investigating consumer complaints, etc.
- Notify relevant national market surveillance authorities about the corrective actions they intend to take, if they suspect an unsafe product has been placed on the EU market. For such exchanges, the importer can use the Product Safety Business Alert Gateway, which is a tool enabling economic operators to directly inform relevant national authorities about dangerous products they are responsible for.
It is also good practice for importers to carry out a general visual check of the products they import to ensure all the required labelling is displayed correctly. Screen tests could be carried out by the importer themselves or they may wish to use independent laboratory tests. The importer may also wish to carry out regular factory visits.
Distributor
A distributor is any other economic operator in the supply chain who does not fall into the definition of manufacturer or importer. Usually, distributors will not directly affect the safety of products, however, their legal obligations relating to the safety of products are as follows:
- monitoring of the marketplace, where appropriate,
- investigating consumer complaints,
- ensuring that labelling (particularly conformity and traceability marks) is correct,
- passing on any information about product safety to the manufacturer or importer, and
- ensuring that storage or transport conditions under their control do not impact on the product’s safety.
If the distributor suspects that a product in their control is unsafe, they must notify the manufacturer or importer of the product and cooperate with market surveillance authorities. Furthermore, if a manufacturer or importer conducts a corrective action, the distributor must fully cooperate.
Fulfilment service provider
The fulfilment service provider has a responsibility to ensure that non-EU manufacturers have fulfilled their legal obligations in order to ensure products entering the EU marketplace are safe and compliant. Fulfilment service providers have an obligation to:
- Verify the manufacturer outside the EU has taken all the necessary steps to allow the product to be placed on the EU market. It is important for a fulfilment service provider to understand the legislation and standards that apply to different products.
- Check all necessary documentation and ensure that it is available upon request. For certain products that require CE marking such as toys and electrical products, this will include technical documentation and the declaration of conformity.
- Monitor the safety of imported products, including through product testing, investigating consumer complaints, etc.
- Notify relevant national market surveillance authorities about the corrective actions they intend to take, if they suspect an unsafe product has been placed on the EU market. For such exchanges, the fulfilment service provider can use the Product Safety Business Alert Gateway, which is a tool enabling economic operators to directly inform relevant national authorities about dangerous products they are responsible for.
It is good practice for fulfilment service providers to sign the Product Safety Pledge and adhere to the rules laid down here.
Authorised representative
An authorised representative shall perform the tasks specified in the mandate and shall have the appropriate means to be able to fulfil their tasks. The representative shall be mandated by the manufacturer to perform the following tasks:
- Verify the manufacturer outside the EU has taken all the necessary steps to allow the product to be placed on the EU market. It is important for an authorised representative to understand the legislation and standards that apply to different products.
- Check all necessary documentation and ensure that it is available upon request. For certain products that require CE marking such as toys and electrical products, this will include technical documentation and the declaration of conformity.
- Monitor the safety of imported products, including through product testing, investigating consumer complaints, etc.
- Notify relevant national market surveillance authorities about the corrective actions they intend to take, if they suspect an unsafe product has been placed on the EU market. For such exchanges, the authorized representative can use the Product Safety Business Alert Gateway, which is a tool enabling economic operators to directly inform relevant national authorities about dangerous products they are responsible for.
The authorised representative must be prepared to provide a copy of the mandate to the market surveillance authorities upon request, in a Union language determined by the market surveillance authority.
Responsible person in the EU
When a manufacturer wishes to sell the product groups listed in Art. 4(5) of the Regulation on Market Surveillance and Compliance of Products online into EU markets, they must have a responsible person in the EU that can be contacted by EU authorities and consumers. It could be an importer, a fulfilment service provider, or an authorised representative. The contact details of the responsible person must be printed on the product.
You can learn more in the Selling online to consumers in the EU module.
