New EU Regulation on Market Surveillance and Compliance of Products

A measure aimed at increasing compliance

Regulation 2019/1020/EU amends the currently applicable Regulation 765/2008/EC and has the main objective to strengthen the compliance of products on the market. Such a need was highlighted due to the rise in non-conformities of products found on the market. Non-compliance of products with the applicable requirements is not only a problem for the safety of consumers but also affects and distorts the competition for economic operators on the EU market.

The new Regulation sets out an obligation for economic operators to cooperate with the market surveillance authorities and establishes a framework for the control of products entering the Union market. Furthermore, the Regulation also tries to address increasingly complex supply chains dynamics and especially online sales of products targeting EU member states.

The Regulation shall enter into force on the 16thof July 2021, with the exception of Articles 29, 30, 31, 32, 33 and 36 which shall apply from 1 January 2021.

The scope and main novelties

The Regulation covers the market surveillance of industrial products (non-food products) and applies to all the products listed in Annex I of the Regulation. However, in accordance with the principle of lex specialis, the new rules on market surveillance shall not replace the market surveillance aspects specifically regulated in the relevant product legislation, for instance  in the Cosmetics Regulation, Medical Devices Regulation and In-Vitro Diagnostics Regulation.

The new inspection activities performed by the market surveillance authorities will follow:

  • a risk-based approach, limiting the burden to what is necessary for the performance of efficient and effective controls.

The market surveillance authorities will consider several elements while performing their activities based on this new approach, such as the economic operator’s past record of non-compliance; possible hazards and non-compliance associated with products and, where available, their occurrence on the market; activities and operations under the control of the economic operator.

  • A case-by- case analysis for online sales taking into account relevant factors:  geographical area in which the dispatch is made available; available languages or means of payment. The Regulation also specifies that products for sale online “shall be deemed to be made available on the market if the sale is targeted for end users in the EU”.

Available measures for non-compliant products

Market surveillance authorities are entitled to take appropriate and proportionate corrective actions to bring any non-compliance to an end or to eliminate the risk within a period they specify, – whenever a product subject to the EU harmonization rules is liable to compromise the safety or health of consumers and does not conform to the applicable legal requirements. The Authorities can also order the recall, or the destruction of the non-compliant products and the Member States can claim back the totality of the costs from the economic operators.

Alessandro Polimeno

Expert Consultant, R&D Department

November 21, 2019

If you wish to receive more regulatory updates concerning the EU and legislation on products, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will gladly answer any question you may have and will gladly assist you in safeguarding and achieving your products’ compliance.

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