EU legislation provides a clear and comprehensive list of obligations for each of these economic operators, and these must be fulfilled for a product to be legally placed on the EU market.
Manufacturers
The manufacturer takes on primary responsibility for ensuring products are safe and compliant, by following the relevant conformity assessment procedure, and documenting it. Other SPEAC Academy modules outline the detail for different products, and, therefore, they are not provided here.
Where the manufacturer is established in the EU and is also the maker of the product, then they must simply ensure that they carry out conformity assessment as laid down in the product specific harmonised Directives or Regulations, and document this adequately. This documentation must be kept for ten years after the last product that the documentation relates to was placed on the EU market and must be provided to market surveillance authorities if they request it.
Other responsibilities include product testing, monitoring of the market for problems, investigating consumer complaints, and taking corrective actions to reduce risk where necessary.
If a manufacturer suspects they have placed an unsafe product on the EU market, they must notify the market surveillance authorities in the Member States where the product has been made available of this and outline the actions they intend to take to correct this. They must also notify distributors of the product, if there are any.
The manufacturer is not always the maker of the product, as branded products are often made by third party production facilities, and this poses challenges in meeting these obligations because they do not have control of the relevant production processes. It is, therefore, essential that conformity assessment at both the design and production phases is adequately documented, so this can be verified as correct.
Importers
Not all products placed on the EU market will have a manufacturer established in the EU. In these circumstances the first person in the supply chain is the importer who has specific responsibilities.
In simple terms, the primary responsibility is to ensure that the non-EU manufacturer has fulfilled their obligations in respect of conformity assessment, and to hold or have access to the technical documentation for ten years evidencing the conformity assessment process and to have verified this.
Following this, other responsibilities are the same as for manufacturers such as product testing, monitoring of the market for problems, investigating consumer complaints, and taking corrective actions to reduce risk where necessary.
There are risks for importers as they are usually completely separate from the production process and ensuring conformity is not as simple as just obtaining a test certificate. There are many risks associated with importing goods. The main risk for an importer is placing a dangerous, non-compliant product onto the EU market. An importer needs to have a good working relationship with the manufacturer, in order to meet the legal requirements in place in the EU and understand any specific product requirements.
If an importer suspects they have placed an unsafe product on the EU market, they must notify the market surveillance authorities in the Member States where the product has been made available of this and outline the actions, they intend to take to correct this. They must also notify the distributors of the product, if there are any.
A two-stage approach is recommended – documentation check and physical goods checks.
Often, it will depend on the type of product being imported, so the importer will need to understand what legislation applies and what European technical standards will be relevant.
The importer must verify that:
- the manufacturer outside the EU has taken the necessary steps to allow the product to be placed on the EU market
- the necessary documentation is available upon request. For certain products that require CE marking such as toys and electrical products, this will be items like the EU declaration of conformity and the technical documentation.
An importer must be proactive in obtaining the required documentation but must also ensure it is correct and relevant. Receiving an EU Declaration of Conformity is great for an importer, but many questions should still be asked:
- Does it relate exactly to the goods being imported?
- Does it have the correct and most up to date legislation and European standards referenced within the declaration?
- Does it have a signature and date?
As well as the documentation check, importers should be conducting physical checks on the product itself. It is good practice to carry out a general visual check to ensure all the required labelling and any required CE mark is displayed, plus the specification has been met. Screen tests could also be carried out on the product especially if the European standards set specific measurements which can be simple measured by the importer.
An importer could also consider using independent laboratory tests. These can be expensive but could make sense if the importer business is based on a small number of products. In addition, although not appropriate for everyone, regular factory visits can also be helpful for the importer.
Distributors
Distributor is a catch all term for any other economic operator in the supply chain who does not fall into the definition of manufacturer or importer. Usually, distributors will not affect the safety of products because if they do then they will, in legal terms at least, become the manufacturer of the final product.
They still have some legal obligations relating to the safety of the product however, which includes monitoring of the market where appropriate, investigating consumer complaints, ensuring that labelling (particularly conformity and traceability marks) is correct, and passing on any information about product safety to the manufacturer or importer. They must also ensure that when under they control storage or transport conditions 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 any action to investigate of correct the issue. Further if a manufacturer or importer instigates a corrective action they must fully cooperate with this.
Authorised representatives
In practice, the appointment of an ‘Authorised Representative’(AR) is optional and not a mandatory one. Manufacturers are required to identify an Economic Operator within the EU, but it does not necessarily have to be an AR – it could be an importer or a Fulfilment Service Provider. Usually, appointing an authorised representative gives the most flexibility. The AR takes on some of the responsibilities of a manufacturer when they are not established in the EU and there is no economic operator acting as importer.
They can only take on limited responsibilities in relation to documentation and corrective action, and only then if specifically authorised in writing to do so by the manufacturer. This is in contrast to an importer, who does not have to have a clearly defined mandate from the manufacturer.
A mandate is a legal document that is usually several pages long and provides a detailed summary of both the manufacturer and the authorised representative’s responsibilities, rights, and duties. It must also include information allowing the identification of the product it covers – for example the model number and product name.
The Authorised Representative must keep the declaration of conformity and the technical documentation at the disposal of the market surveillance authorities. They must also cooperate with the market surveillance authorities if enforcement action is taken against them. Finally, they must perform any other tasks identified in the written mandate agreed between them and the manufacturer.
