New EU regulation on market surveillance and compliance of products

The rules on market surveillance and mutual recognition of products have been reformed in the European Union.

Background and starting points

In autumn 2017, the European Commission adopted two proposals for regulations (the so-called Goods package). One of the proposals concerned the compliance and market surveillance of products (hereinafter referred to as the “Market Surveillance Regulation”) and the other one the mutual recognition of products. Both EU regulations have now been adopted and published in the Official Journal of the European Union. They will replace the earlier regulation from 2008: Regulation (EC) No 764/2008 on mutual recognition and Regulation (EC) No 765/2008 on market surveillance and accreditation, except for the parts concerning accreditation.

The scope of application of the Market Surveillance Regulation (EU) 2019/1020 is broad and concerns the majority of the product sectors that are subject to the EU’s harmonisation regulation. The regulation on mutual recognition (EU) 2019/515, on the other hand, is applicable to products for which there is no EU level harmonisation legislation. This page presents the Regulation on market surveillance and compliance of products.

Content of the Market Surveillance Regulation

The objective of the Market Surveillance Regulation is to reduce the number of non-compliant products in the internal market, enhance market surveillance and improve the functioning of the internal market. The objective is also to create equal competitive conditions for all economic operators.

The Market Surveillance Regulation is applied to the product sectors covered by 70 sector-specific legal acts issued on products by the EU. These product sectors have been listed in Annex 1 of the Regulation. Most of the provisions of the Market Surveillance Regulation concern market surveillance authorities and their operation, but the Regulation also lays down provisions on procedures concerning the control at external borders and sets obligations for economic operators.

The new Market Surveillance Regulation is for its part aimed at responding to the challenges caused by non-compliant products from third countries, which arrive to the EU through online sales. On the one hand, such products are often a safety risk for the user and on the other, non-compliance with EU regulations may result in competitive advantage being gained by these operators located outside the EU, at whose products market surveillance is difficult to target. Article 4 of the Regulation sets a condition for placing a product on the EU market, requiring that a designated economic operator established in the EU must be responsible for certain tasks related to product compliance and that the market surveillance authority can take certain measures against this operator. Such an economic operator is primarily the manufacturer or the importer, but in their absence, either a representative authorised by the manufacturer or, as the last resort, the fulfilment service provider. However, the requirements in Article 4 are only applied to certain product sectors that have mainly been selected on the basis of potential risk. These product sectors have been listed in the Article in question. As for the application of the Article, the provision in Article 6 on when the products offered for sale online or through other means of distance sales are deemed to have been made available in the market also plays a central role.

Different cooperation procedures of the authorities are one of the new means of enhancing market surveillance proposed in the Market Surveillance Regulation.

For example, provisions on the following cooperation procedures are laid down in the Regulation:

  • Article 9 - market surveillance authorities’ joint activities with other authorities and economic operators
  • Article 12 - a peer review procedure for the market surveillance authorities wishing to participate in such a review
  • Articles 22-24 (Chapter VI) - mutual assistance of market surveillance authorities across the borders between the Member States
  • Articles 29-35 (Chapter VIII) - other coordinated enforcement and international cooperation

In addition, the procedures concerning the cooperation of market surveillance authorities and customs authorities in controlling the Union’s external borders have been specified to enhance control (Chapter VII).

The Regulation contains provisions on the minimum level of the market surveillance authorities’ powers. The market surveillance authorities’ minimum powers include new powers such as the power to purchase product samples under a cover identity and the power to require certain content to be removed from the online interface or, as the last resort, to require that access to the online interface be restricted. Furthermore, according to Article 15 of the Regulation, Member States may authorise their market surveillance authorities to charge economic operators in totality the costs related to the market surveillance authorities’ activities in cases where a product’s non-compliance is established.

The Market Surveillance Regulation was published in the Official Journal of the European Union on 25 June 2019 and it has entered into force on 15 July 2019. Its application will mainly begin two years after the entry into force, on 16 July 2021. Provisions on several matters in the Market Surveillance Regulation must still be laid down in national legislation and the time available for this implementation work is the aforementioned two years. The Commission also plays a central role in the implementation of the Regulation and in questions related to its application.

Further information: laura.holkko(at)tem.fi and emilia.tiuttu(at)tem.fi