The European Commission is adopting a new regulation for market surveillance to ensure the safety of products sold within the European Union: Regulation (EU) 2019/1020. The regulation, which will come into force July 2021, requires all products sold in the European Union (whether sold directly, online, or through a fulfillment service provider) to be registered with an official responsible party based in the EU.
A ‘responsible party’ can be a manufacturer, importer, distributor, fulfillment service provider, or Authorised Representative. Distinguishing different actors in the supply chain is not always clear-cut, which is why we created an overview of how these roles are defined according to the European Commission. We will also explain what it means to appoint a ‘responsible party’ to help you prepare for the implementation of the Market Surveillance Regulation.
Responsibilities of the manufacturer when CE-Marking
The European Commission defines a manufacturer as “any natural or legal person who manufactures a product or has a product designed or manufactured, and markets the product under its name or trademark.” You are a manufacturer if:
- You place products onto the market under your name or trademark
- You assemble, pack, process, or label ready-made products and place them under the market under your own name or trademark
- You change the intended use, substantially modify or re-build a product in such a way that other legal requirements for CE marking become applicable than for the original product
The manufacturer is responsible for designing, manufacturing, and carrying out the essential conformity assessment in accordance with the procedure(s) outlined in the applicable EU harmonised standards. Regardless of whether the manufacturer has appointed an authorised representative or another party to act on their behalf, the manufacturer will always be held accountable for ensuring that their product complies with relevant standards. For the same reason, the following sentence must be included in the EU Declaration of Conformity: “This Declaration of Conformity is issued under the sole responsibility of the manufacturer.”
Responsibilities of the importer
An importer refers to “any natural or legal person established within the Union who places a product from a third country on the Union market.” A ‘third country’ is any country not established within the European Economic Area (EEA).
The importer has a restricted but clearly described responsibility under the EU rules and regulations if they are not based in the European Union. The importer must ensure that the manufacturer has drawn up the technical documentation and carried out the appropriate conformity assessment procedures.
Until now, consumers have been considered the importers of the products they buy online from non-EU companies, meaning that they are legally responsible for ensuring that these products comply with EU safety standards. In reality, most end-users are unaware of this, and it is unreasonable to expect consumers to take legal responsibility for compliance. The new market surveillance regulation closes this loophole by requiring an official representative for all products sold on the EU single market (directly or online).
Responsibilities of the distributor
A distributor is “any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a product available on the market.” Distributors include wholesalers, retailers and other merchants who make products available on a market.
Distributors acquire products for further distribution either from a manufacturer, an importer or from another distributor. They are responsible for identifying the manufacturer, their authorised representative (if applicable), and the importer (if applicable). They must have knowledge of CE marking regulations applicable to the products being distributed and establish an official contract with the manufacturer.
Responsibilities of the fulfilment service provider
A fulfilment service provider is “any natural or legal person offering at least two of the following: warehousing, packaging, addressing and dispatching, without having ownership of the products involved.”
Fulfilment service providers such as Amazon have increased responsibilities under the new market surveillance regulation: when there is no other established representative for a product, they will be held responsible. It is therefore crucial for fulfilment service providers to ensure that all parties making use of their platform are conforming to the new regulation by registering their products with an official EU representative.
Responsibilities of the Authorised Representative
An Authorised Representative is “any natural or legal person based in the European Union who has a written mandate from a manufacturer to act on its behalf.” A manufacturer can be based anywhere, but they must have a representative based in the EU to sell their products in Europe. Non-EU manufacturers can appoint an Authorised Representative (AR) to act on their behalf.
Unlike an importer or distributor, an AR is not economically or commercially involved with the concerned products. Once an official contract is drawn up between the manufacturer and the AR, the Authorised Representative will have access to the Technical File and Declaration of Conformity of the concerned product. Responsibilities of the AR include acting as the official EU point of contact and cooperating with national surveillance bodies and/or competent national authorities.
Responsibilities of the responsible party under regulation (EU) 2019/1020
The new Market Surveillance Regulation states that all products must have an appointed responsible party or ‘economic operator’ before they can be placed on the European market. Their responsibilities include:
- Verifying CE marking
- Registering as the EU point of contact, such as an Authorised Representative
- Ensuring the availability of Technical Files and Declaration of Conformity
- Cooperating with market surveillance authorities
- Informing authorities when there is reason to believe that a product presents a risk
The responsible party can be the manufacturer, importer, distributor, fulfillment service provider or Authorised Representative. However, they must be based in the European Union, and they must be accountable for the responsibilities outlined above. Strengthened market surveillance and possible penalties under the new regulation will enforce the role of the appointed responsible party.
The contact information of the responsible party should also be provided on the product and/or its packaging. If competent authorities wish to see the Technical Documentation, it should be made readily available.
Prepare for the market surveillance regulation with AR Experts
Is your business located outside of the European Union? AR Experts, part of Certification Experts, registers as your official EU Authorised Representative or EC Rep, so that you can trade in the EU directly or online no matter where you’re located. Please feel free to contact us.
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