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New General Product Safety Regulation of the EU Enters into Force

New General Product Safety Regulation of the EU Enters into Force

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The new General Product Safety Regulation of the EU, which has recently entered into force, was published in the Official Journal of the EU on May 23, 2023, and it shall start to apply on December 13, 2024 (“the Regulation”).

The Regulation is a new key instrument in the EU product safety legal framework, replacing the current General Product Safety Directive and the Food Imitating Product Directive. The Regulation therefore improves the EU regulatory framework regarding product safety and addresses the new challenges posed by the digitisation of economy.

Application and aim of the Regulation

Namely, the Regulation sets out general rules on product safety placed in the EU market, for the purpose of improving market functioning along with ensuring high level of consumer protection.

The Regulation applies to products placed in the market if there are no special provisions within the EU law with the same purpose, i.e., which regulate the safety of specific products concerned. If the products according to the EU regulations are subject to special safety requirements, the Regulation shall only apply to those aspects and risks or categories of risks that are not envisaged by such requirements.

Furthermore, the Regulation pertains to so-called non-food products and to all sales channels. Provision of Article 2, paragraph 2 of the Regulation enlists the categories of products that are exempt from its application (e.g., food, feed, medicinal products for human or veterinary use, living plants and animals etc.).

In addition, the General Regulation applies to products placed in the market whether new, used, repaired or reconditioned, unless the products need to be repaired or reconditioned prior to being used, i.e., if they are placed on the market and are clearly marked as such.

Content of the Regulation

The Regulation particularly focuses on distance sales and stipulates that the products offered for sale online or through other means of distance sales should be considered to have been made available on the market if the offer for sale is targeted at consumers in the EU, i.e., if the relevant economic operator directs, by any means, its activities to one or more Member States and prescribes special obligations of such entities. Therefore, if a manufacturer does not have seat in the EU, it shall be obliged, inter alia, to clearly and visibly indicate on the product offer the name, postal and electronic address of the responsible person for products placed on the EU market (from Article 16, paragraph 1 of the Regulation).

In relation thereto, the Regulation prescribes that the product covered by its provisions shall not be placed on the market unless there is an economic operator in the EU territory with seat in the EU, which is responsible for such product in terms of provision 4(3) of the EU Regulation on market surveillance and compliance of products (2019/1020). Accordingly, if a product is placed on the EU market by an entity that does not have official seat on the EU territory, the prescribed obligations shall be performed on its behalf and for its account by an authorized representative (with seat in the EU) who has a written mandate.

In addition, the Regulation stipulates special obligations for providers of online marketplaces. For instance, they are obliged to register in the Safety Gate Portal (providing the general public with free of charge and open access to selected information regarding product safety, e.g., on dangerous products), to designate a single point of contact to enable consumers to communicate directly and rapidly with them in relation to product safety issues, to ensure that they have internal processes for product safety in place in order to comply without undue delay with the relevant requirements of this Regulation etc.

In addition to the Safety Gate Portal, as a rapid alert system, the Regulation also provides for the Safety Business Gateway portal, through which businesses and providers of online marketplaces can easily provide all relevant information to national market surveillance authorities and consumers.

According to the Regulation, the EU Member States shall lay down the rules on penalties applicable to infringements of the Regulation and shall ensure that they are effective, proportionate and dissuasive.

Considering all of the previous trends and legislative practice in Serbia, we can expect that relevant domestic legislation will be harmonized with the Regulation requirements in the upcoming period.

This article is to be considered as exclusively informative, with no intention to provide legal advice. If you should need additional information, please contact us directly.

By Ivana Ruzicic, Partner, and Lara Maksimovic, Senior Associate, PR Legal

PR Legal at a Glance

PR Legal is a Serbian business law firm which renders advice on a full range of corporate matters, from day-to-day legal issues to large M&A and capital-raising transactions. We provide high-quality legal services to companies, entrepreneurs, private entities, and public institutions, in a modern and pro-active manner, based on unique professional experience in high-profile transactions and disputes.

Always aiming for practical feasibility, and when necessary, dig deep in order to secure our clients’ best interests, either before the court, state authorities or counterparties. In any case, commitment is omnipresent in all our work.

We distinguish ourselves from our competitors through understanding of commercial interests considering present legal framework, by providing smart and cost-effective business solutions, and most of all by our passion for doing business.

In PR Legal we believe that exceptional results can be achieved only when talented and reliable people work together in the appropriate environment. With such approach and commitment, our focus is on teamwork and encouraging of relationships based on trust and cooperation. Investment in our people is investment in our future, which allows us to provide comprehensive and top-quality assistance to our clients.

We care about our clients, while the building of strong relationships and a culture of excellent client service remains our main compass.
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