Consolidation of EU market surveillance

Goodbye to unsafe products?

Regulation (EU) 2019/1020 (OJ L 169, 25.6.2019, p. 1 - 44) consolidates the EU-wide framework for market surveillance and adapts it to new circumstances. It will enter into force on the twentieth day following its publication in the Official Journal and will apply in full from 16.06.2021 or partially as early as 01.01.2021.

Scope

The Regulation generally applies for all products marketed in the EU unless more specific statutes apply which have the same objectives. In addition to products which are subject to EU harmonizing legislation, all other products imported into the EU from a third country for free circulation within the EU also fall within the scope of the Regulation.

Key Content

In addition to measures designed to intensify and make cooperation between market surveillance authorities more efficient, the former rules for ensuring the conformity of products with EU harmonizing legislation are revised, particularly in light of the growth in online retail and global supply chains, and the powers available to the authorities in this regard are specified.

Under the Regulation, a product is considered to be marketed and subject to EU harmonizing legislation if it is offered to end users in the EU online or through another form of distance selling. However, the mere availability of the product within the territory of the EU is not enough. The decisive question is whether the offering of the product is actually directed towards the EU internal market, which can be ascertained e.g. based on possible delivery regions, available languages or payment types.

In addition, the activities of the market surveillance authorities are extended to new links of the supply chain. These particularly include "fulfilment service providers," whose functions are largely similar to those of the previously defined category of importers, but which do not quite meet the definition of importers. The Regulation defines "fulfilment service provider" as any natural person or legal entity which, in the course of its business activity, provides at least two of the following services for products which it does not own: storage, picking, packaging, and shipping.

The aforementioned "fulfilment service providers" fall into the category of "economic operator" along with manufacturers, importers and agents. Any duties under the Ordinance which are not already performed by another economic operator must be performed by the fulfilment service provider. This particularly includes ensuring that the EU conformity declaration and technical documents are prepared, that high-risk products are reported to the authorities and working with the authorities to eliminate risks. In addition, the fulfilment service provider is required to specify its name or brand name on the product, packaging, parcel or accompanying documentation.

Member states are also to set up suitable controls with respect to products entering the EU market. Authorities which are specifically designated for this purpose are to perform risk-based checks and, if necessary, take effective measures to counteract any risks arising from products entering the EU market.

Practical notes

The Regulation may result in a significant increase in requirements, as well as a corresponding increase in regulatory activity, especially for the newly defined economic operators. Appropriate structures should be created at an early date in order to ensure proper compliance with these requirements.

[July 2019]