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Most non-EU companies did not need to have an economic operator inside the EU prior to July 2021. As an alternative, they could market their products directly to consumers or through companies that offer fulfillment services, like Wish, Amazon, or Alibaba. The quality of the products could not be controlled, and it was unclear who was in charge of ensuring that they complied with regulations. But after the new Market Surveillance Regulation (EU) 2019/1020 was implemented, the market environment changed. The Regulation went into effect, adding new requirements to all goods sold within the EU and requiring non-EU manufacturers to designate an Authorised Representative.
If your company is based outside of the European Union, you must have an EU Authorised Representative to confirm that your products are legitimately CE marked and permitted for sale inside the EU. Furthermore, due to Brexit, you also need an EU Authorised Representative if you're based in the UK. Otherwise, you need to suspend all your business activities within the EU.
Regardless of your location, TerrainQ Market Access can assist you in complying with the new Market Surveillance Regulation right away. To quickly address issues with your Authorised Representative, order your subscription from us.
With the Market Surveillance Regulation 2019/1020, which came into force in July 2021, the EU is ensuring tighter market surveillance in the internal market and making an important contribution to general product safety, especially in e-commerce.
The import of unsafe products from third countries, in particular, is regulated more strictly by expanding the concept of "putting products on the market" and by including fulfillment service providers as defined economic actors.
The new regulation stipulates that a person in the European Union must act as the contact person for product conformity for CE-marked products.
An economic operator is a term that is used in European Union (EU) regulations to refer to any person or organization that is involved in economic activities, such as producing, buying, selling, or distributing goods or services. Economic operators can include businesses, manufacturers, retailers, wholesalers, and other organizations that are involved in the production, distribution, or sale of goods and services within the EU.
Economic operators are subject to a wide range of EU regulations, which are designed to ensure fair competition and protect the interests of consumers and businesses within the EU. These regulations can cover a wide range of topics, including consumer protection, product safety, and environmental protection.
Manufacturers and sellers who are not established in a European Member State must appoint an authorised representative. This authorised representative represents the manufacturer in the EU.
If you are selling CE marked products manufactured outside of the EU, you must ensure that these products have an authorised representative in the EU before July 16, 2021. After that, it will be illegal to sell CE marked products in the EU without one.
The European legislator requires manufacturers located outside the European Economic Area to label products with the name and address of their EU Authorised Representative, should they make them available on the EU internal market.
The EU Commission and Customs are working with manufacturers and EU Authorised Representatives to protect consumers, the environment and to better ensure the traceability of products.
The EU Authorised Representative is a person or an organization that is responsible for representing a manufacturer of CE marked products in the European Union. The main responsibility of the EU Authorised Representative is to ensure that the manufacturer's products comply with all relevant EU regulations and standards. This can include helping the manufacturer with the technical documentation required for product approval, as well as coordinating with EU authorities on any issues that may arise.
The EU Authorised Representative acts as a point of contact between the manufacturer and the EU authorities, and is responsible for ensuring that the manufacturer's products are safe and effective for use in the EU market.
If you are a manufacturer of CE marked products based outside of the European Union and you do not have an EU Authorised Representative, you will not be able to sell your products in the EU market. This is because EU regulations require that non-EU manufacturers appoint an EU Authorised Representative who is based in the EU and can act on their behalf in dealing with EU authorities.
Without an EU Authorised Representative, your products will not be able to obtain the necessary approvals and certifications to be sold in the EU market. It is important to note that failing to appoint an EU Authorised Representative, or selling products in the EU market without one, can result in penalties and other legal consequences. Here are some examples:
Fines
If the address and name of the Authorised Representative are missing on the product, a fine of up to €10,000 may be imposed.
Product recall and destruction
Companies must expect product recalls and product destruction if the goods are inspected by customs.
Sales ban
In the event of repeated infringements, the authorities may impose a sales ban.
Sales restrictions can also be imposed on online marketplaces such as Amazon, eBay or Etsy.