December 16, 2019
Elena Andreula – EMEA Regulatory Program Expert
On June 25, 2019, the Regulation (EU) 2019/1020 on market surveillance and compliance of products amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 was published in the Official Journal of the European Union.
The objective of this market surveillance regulation is to improve the function of the internal market and keep non-compliant products from being placed on the Union market by strengthening market surveillance of products, providing economic operators with clear, transparent and comprehensive rules, intensifying compliance controls and promoting closer cross-border cooperation among enforcement authorities, including customs authorities.
The provisions on market surveillance of this regulation apply to all products subject to Union harmonization legislation listed in Annex I. Some of the main changes and innovations:
A product may be placed on the market only if there is an economic operator established in the Union who is responsible for specific tasks. Some of the main tasks:
- Verify that the EU declaration of conformity and technical documentation have been drawn up and they are available to market surveillance authorities
- Further to a reasoned request from a market surveillance authority, provide authority with all information and documentation necessary to demonstrate the conformity of the product in a language which can be easily understood by that authority
- Cooperate with market surveillance authorities regarding actions which could eliminate or mitigate risks that are presented by products made available on the market
The postal address of the economic operator shall be indicated on the product or on its packaging, the parcel or an accompanying document.
Fulfillment Service Provider
The new regulation also includes responsibilities for Fulfillment Service Provider. The role of this Economic Operator was already mentioned in the Blue Guide. Now it has been much more defined, and it performs many of the same functions as importers.
Products offered for sale online or through other means of distance sales shall be deemed to be made available on the market if the offer is targeted at end users in the Union. In order to carry out market surveillance of products made available online and offline with the same effectiveness for all distribution channels, Member States shall ensure that their market surveillance authorities and single liaison office have the necessary resources, including sufficient budgetary and other resources such as a sufficient number of competent personnel, expertise, procedures and other arrangements for the proper performance of their duties.
Joint activities to promote compliance
Market surveillance authorities may agree with other relevant authorities or with organizations representing economic operators or end-users on the carrying out of joint activities that have the aim of promoting compliance, identifying non-compliance, raising awareness and providing guidance in relation to the Union harmonization legislation with respect to specific categories of products, in particular categories of products that are often found to present a serious risk, including products offered for sale online.
Power of market surveillance authorities
- Member States shall confer on their market surveillance authorities the powers of market surveillance, investigation and enforcement necessary for the application of this Regulation and for the application of Union harmonization legislation. The powers conferred on market surveillance authorities include, for example:
- The power to require economic operators to provide relevant documents, technical specifications, data or information on compliance and technical aspects of the product
- The power to carry out unannounced on-site inspections and physical checks of products
- The power to require economic operators to provide relevant information required for the purpose of ascertaining the ownership of websites
- The power to enter any premises, land or means of transport that the economic operator in question uses for purposes related to the economic operator's trade, business, craft or profession, in order to identify non-compliance and to obtain evidence
- The power to impose penalties
- To require the removal of content referring to the related products from an online interface or to require the explicit display of a warning to end-users when they access an online interface
Each Member State shall draw up an overarching national market surveillance strategy, at least every four years. Each Member State shall draw up the first such strategy by 16 July 2022.
Union testing facilities
The objective of the Union testing facilities is to contribute to enhancing laboratory capacity, as well as to ensuring the reliability and consistency of testing, for the purposes of market surveillance within the Union. The Commission may designate a public testing facility of a Member State or may also designate one of its own testing facilities as a Union testing facility. Union testing facilities shall be accredited in accordance with Regulation (EC) No. 765/2008. Designated Union testing facilities shall provide their services solely to market surveillance authorities, the Network, the Commission and other government or intergovernmental entities.
Union Product Compliance Network
A Union Product Compliance Network (“the Network”) is established. The purpose of the Network is to serve as a platform for structured coordination and cooperation between enforcement authorities of the Member States and the Commission, and to streamline the practices of market surveillance within the Union, thereby making market surveillance more effective.
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