The EU Market Surveillance Regulation: What is it and how can it affect your business?

What is the EU Market Surveillance Regulation?

The Market Surveillance Regulation was adopted by the European Commission to ensure the safety of products sold within the European Union. It is part of the Goods package and aims to ensure that products placed on the EU single market are compliant with EU legislation.

The need for extra efforts to keep unsafe products off the EU market is largely due to challenges posed by increasingly popular e-commerce and online trade. Until now, consumers have been considered the importers of the products they buy online. Importers are legally responsible for ensuring that products comply with EU safety standards, yet most end-users have been unaware of whether the products they buy online are certified as safe or not.

The Market Surveillance Regulation closes this loophole by strengthening controls on products sold in the EU in three main ways:

• All non-EU manufacturers must have an ‘economic operator’ in the EU
• Strengthened market surveillance of products
• Stricter controls at the EU border

What is an economic operator?

An economic operator can be one of the following:

• Manufacturer
• Importer into the EU (if the manufacturer is not established in the EU)
• Authorised Representative
• Fulfillment service provider (person or company responsible for warehousing, packaging, addressing and/or dispatching products/on-line webstore)

Under the Market Surveillance Regulation, suppliers must have an economic operator established within the European Union to sell their products in the EU. Stricter controls, strengthened market surveillance and possible penalties will enforce the responsibilities of economic operators, which include:

• Ensuring the availability of conformity documentation
• Cooperating with market surveillance authorities
• Informing authorities when there is reason to believe that a product presents a risk

Who will be affected by the Market Surveillance Regulation?

The new regulation will affect manufacturers based outside of the EU, consumers in the EU and fulfillment service providers. It will have the greatest impact on online sales where the business is based outside of the EU and the consumer is in the EU. By strengthening compliance checks for products, consumers can be assured that the products they order online will meet the EU harmonised standards for health and safety.

How to prepare for the enforcement of the Market Surveillance Regulation?

If your business is established outside of the European Union and you want to sell your products in the EU either directly, online, or through a fulfillment service provider, you will need an EU economic operator to do so. This applies for all products that fall under EU harmonisation legislation, including (but not limited to):

• Construction products
• Medical devices
• Machinery
• Toys
• Cosmetics
• Radio equipment
• Pressure equipment
• Electrical and electronic equipment

Certification Experts can take on the role of economic operator as an EU Authorised Representative or EC Rep. If you are interested in our AR service or have more questions about the Market Surveillance Regulation, contact us today.