New guidelines on Art. 4 of the EU Market Surveillance Regulation 2019/1020

Economic operator in the EU from 16.07.2021 mandatory

On July 16, 2021, the provisions of the new EU Market Surveillance Regulation (EU-MÜV) 2019/1020 will go live. The new regulations on market surveillance and product conformity are intended to ensure compliance with EU requirements. For the provisions of Article 4, the Commission has now published the guidelines in the EU Official Journal C 100 (2021/C 100/01) on March 23, 2021. 

Essentially, Article 4 requires that certain products may only be placed on the EU market if there is an economic operator established in the EU who can provide information or take certain actions to the authorities upon request. However, these guidelines refer exclusively to those product regulations that are listed in Art. 4 (5) of the EU MOT: 

Regulations (EU) no. 305/2011 (construction products), 2016/425 (personal protective equipment) and 2016/426 (gas appliances) and Directives 2000/14/EC (noise emissions in the environment from equipment intended for use outdoors), 2006/42/EC (machinery), 2009/48/EC (toys), 2009/125/EC (energy-related products - eco-design), 2011/65/EU (RoHS), 2013/29/EU (pyrotechnic articles), 2013/53/EU (recreational craft and personal watercraft), 2014/29/EU (simple pressure vessels), 2014/30/EU (EMC), 2014/31/EU (non-automatic weighing instruments), 2014/32/EU (legal for trade measuring instruments), 2014/34/EU (ATEX), 2014/35/EU (low voltage products), 2014/53/EU (radio equipment) and 2014/68/EU (pressure equipment). 

These pieces of legislation require an economic operator if products are to be placed on the EU market from July 16, 2021. What is new here is that if products are offered for sale online or via another form of distance selling, the product is deemed to be made available on the market if the offer is directed at end users in the EU. Accordingly, an economic operator must first ensure that there is an economic operator for that product in the EU in accordance with Article 4. Otherwise, he cannot place such product on the EU market as of July 16, 2021. 

Economic operators can be:

  • a manufacturer established in the EU; 
  • an importer established in the EU, if the manufacturer does not have an establishment in the EU; 
  • an authorized representative established in the EU who has been mandated in writing by the manufacturer to perform the tasks specified in Article 4(3) on behalf of the manufacturer; 
  • a fulfilment provider established in the EU, if there is no manufacturer, importer or authorised representative established in the EU. 

If a manufacturer not established in the EU has not designated an authorized representative, the product may not be offered for sale to end users within the EU. The economic operator wishing to offer the product for sale to EU end-users must therefore ensure that the manufacturer designates an authorized representative for the product. 

From this requirement we at GLOBALNORM have created a new service: We will gladly perform the tasks of an authorized representative for your company. If you are interested in details about our authorized representative service, please send us an inquiry to info@globalnorm.de.

An important requirement under Article 4(4) is the provision of certain information. The name, registered trade name or registered trade mark and contact details including the postal address of the economic operator must be indicated on the product or its packaging, package or in an accompanying document. Here, this provision overrides certain sector regulations that do not require this.

If, during a review, the market surveillance authorities find that the economic operator's name and contact details are missing in accordance with Article 4, they will require the relevant economic operators to take corrective action. They also have the power to impose sanctions (Article 14(4)(i) of the EU MoU). 

In our webinar (see here in german, english language on request), we will present these guidelines in more detail to interested economic operators in the context of the new EU-MÜV and explain which recommendations for action derive from them. 

In order to fulfill their mandate, market surveillance authorities are required to carry out appropriate checks on the characteristics of products to an appropriate extent (Article 11(3) of the EU MOT). In deciding which types of products should be subject to which reviews and to what extent, market surveillance authorities take a risk-based approach. It will be interesting to observe how intensively the market surveillance authorities will actively approach this task. 

For Germany, the Federal Ministry for Economic Affairs and Energy (BMWi) is in charge of coordinating cross-sectoral market surveillance as a statutory task within the federal government. It also represents Germany on market surveillance issues at the European level in legislative measures and in the enforcement aspects specified in European legislation. After coordination between the federal ministries and the federal states, the German Market Surveillance Forum (DMÜF) was set up at the BMWi to advise and support the federal government on market surveillance issues within the scope of the EU MOT. 


If you would like to expand your know-how not only with regard to the post-market obligations arising from the EU-MÜV 2021/1020, but also in the context of ensuring the marketability of products, technical product conformity as well as the RAPEX guidelines of the Implementing Decision 2019/417, we recommend our course to become a certified Product Compliance Officer (PCO) according to ISO/IEC 17024 (see here in german, english language on request). 

Published on 20.04.2021
Category: Fokus Consumer Goods & Retail, Compliance

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