As of 13 December 2024, the new Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety (the “Regulation”; the text of the Regulation is available here), also known as the GPSR (General Product Safety Regulation), comes into force as a new instrument for ensuring the safety of products supplied to consumers within the internal market of the European Union, therefore including the Czech Republic. The main objective of the Regulation is to replace the outdated harmonised regulation based primarily on Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety, and thus to establish a single legal framework with more effective rules and procedures for ensuring the safety of goods placed on the EU market and supplied to end consumers.
The newly adopted rules aim to ensure even more extensive consumer protection, inter alia by imposing specific obligations on the economic operators concerned across the production and distribution chain. In particular, the Regulation aims to ensure the safety of all products, better enforcement of the rules and more effective supervision of the European market. At the same time, it sets up more effective mechanisms and measures to withdraw dangerous products from the market and circulation. The regulation also takes into account the new challenges posed by the online sale of goods.
This article aims to present the Regulation primarily from the perspective of the economic operators who will be affected by the new rules, i.e. in particular manufacturers, importers and distributors of goods, as well as operators of online sales platforms – in particular e-shops or online marketplaces.
Scope of the Regulation
The Regulation applies generally to all non-harmonised products placed or supplied on the EU internal market, subject to certain exceptions set out below.
The Regulation specifically states that it does not apply to the following products:
- medicinal products for human or veterinary use,
- food and feed,
- live plants and animals, genetically modified organisms and micro-organisms in contained use, as well as plant and animal products directly related to their future reproduction,
- animal by-products and derived products (e.g. wool),
- plant protection products (e.g. pesticides),
- equipment used by consumers for driving or travelling, if directly operated by the transport provider,
- aircraft whose design, manufacture, maintenance and operation present a low safety risk,
- antiques,
- products clearly marked to be repaired or reconditioned before use.
As general product safety legislation, the Regulation does not apply to products subject to special legislation, such as children’s toys.
The obligations under the Regulation apply to all economic operators, i.e. manufacturers, importers and distributors, in all sales channels, including online marketplaces and e-shops.
Main obligations of manufacturer
According to the Regulation, a manufacturer is a natural or legal person who places on the market a product which he manufactures or has designed or manufactured himself, under his name or trademark.
The fundametal obligation of any manufacturer is to ensure that its products are safe, right from the initial design stage. This is to be achieved through the obligation to carry out internal risk analyses and the obligation to draw up appropriate technical documentation on the safety of the product and to keep this documentation for a specified period (10 years after placing on the market).
In addition to these obligations, the manufacturer must ensure that the consumer is sufficiently informed of some specific data. This includes the identification of the product, which includes the indication of the product type, batch, serial number or other identifying data on the product itself or on its packaging or a document accompanying the product. At the same time, the manufacturer must include clear instructions and safety information (in the Czech language) with the product, unless the product can be used safely without such instructions or information. The manufacturer must also indicate on the product or its packaging manufacturer’s identification and contact details (name, registered trade name or registered trade mark of the manufacturer, postal and electronic address at which it can be contacted). In addition, that information may also be provided digitally (for example, by means of QR codes or data matrix codes).
The manufacturer is also obliged to keep internal records of complaints received (and investigated), as well as of product safety incidents, product withdrawals and actions taken; again, the data recorded must be kept for a specified period of time (no longer than 5 years after the entry).
Where a manufacturer considers that a product it has already placed on the market is unsafe, it must immediately inform consumers concerned as well as the national authorities (via the new Safety Business Gateway). It must also take the necessary measures to bring the product concerned effectively into compliance with the Regulation, including, where appropriate, withdrawing the product from the market and from circulation.
In the event of an accident is caused by a product placed or supplied on the market, the manufacturer must immediately inform the competent authorities of the Member States, via the aforementioned Safe Business Gateway. Importers and distributors are not obliged to do so but must immediately inform the manufacturer who will make the appropriate notification (or delegate this to the importer or distributor).
Manufacturers may appoint an authorised representative to fulfil their obligations.
For the sake of completeness, it should be added that if a person other than the manufacturer places a product on the market under his name or trademark, or if he makes a substantial modification to the product, he is considered to be the manufacturer for the purposes of this Regulation and is subject to the obligations of the manufacturer set out in the Regulation.
Main obligations of the importer
Under the Regulation, an importer is a natural or legal person established in the EU who places a product on the EU market originating from a country outside the EU.
Each importer must ensure that the product it places on the market meets the general safety requirement of the Regulation and that the manufacturer has complied with the relevant obligations imposed on it by the Regulation (internal risk analysis, technical documentation, product identification, identification and contact details of the manufacturer). Otherwise, the importer is obliged to refuse to place the non-compliant product on the market.
Similarly to manufacturers, importers are required to include their identification and contact details on the product or its packaging, and importers are also required to ensure that clear instructions and safety information accompany the product (in the Czech language), unless they are not necessary. The importer is also obliged to keep a copy of the technical documentation for the product for a specified period of time (10 years after placing on the market) and to make it available to the competent surveillance authorities upon request.
Furthermore, it is the importer’s responsibility to ensure that the storage and transport conditions of the products do not compromise compliance with the general safety requirement of the Regulation.
If the importer believes that it has placed an unsafe product on the market, it must inform the consumer, the manufacturer and the national market surveillance authorities (via the Safety Business Gateway). Like the manufacturer, the importer must take the necessary measures to bring the product concerned effectively into compliance with the Regulation, including withdrawing the product from the market and from circulation. The importer is not exempted from other obligations similar to those of the manufacturer with regard to the investigation of complaints and the keeping of records on product safety (complaints, accidents, recalls or measures taken).
Main obligations of distributor
A natural or legal person in the supply chain, other than the manufacturer or importer, who supplies a product to the market is called a distributor by the Regulation.
Before placing a product on the market, each distributor is obliged to verify that the manufacturer and importer, if any, have complied with the relevant product safety requirements under the Regulation (identification of the product, identification and contact details of the manufacturer/importer, attaching instructions or safety information as appropriate). If the product does not meet these conditions, the distributor must refuse to supply the product to the market.
Similarly to the importer, the distributor is also responsible for the storage and transport conditions of the products so that they do not compromise the compliance of the products with the general safety requirement of the Regulation.
If a distributor believes that a product it has placed on the market is unsafe or does not comply with the requirements of the Regulation, it is obliged to inform the manufacturer or the importer, where applicable, and to ensure that the national market surveillance authorities are informed (via the Safety Business Gateway) and to ensure that the necessary corrective measures are taken to bring the product concerned effectively into compliance with the Regulation, including its withdrawal from the market and from circulation.
Other obligations of economic operators
According to the Regulation, a product can only be placed on the EU market if a person established in the EU is designated to be responsible for carrying out certain tasks in relation to ensuring the safety of the product – i.e. there must always be an entity within the EU that will carry out the obligations under the Regulation and will also be a partner for the surveillance authorities.
In addition to the specific obligations of individual operators described above, the Regulation contains a list of general obligations that apply to all operators. It lists the establishment of internal processes for compliance with the Regulation’s product safety requirements as a basic obligation, followed by the obligation to cooperate with market surveillance authorities.
Economic operators must also be prepared to provide specific information in relation to the product (e.g. description of risks, complaints made, or corrective measures taken, traceability of the supply chain) at the request of the surveillance authority for a period of 6 to 10 years after the product has been supplied.
Product withdrawal and consumer remedies
In the event of a product withdrawal or where it is necessary to communicate certain information to consumers to ensure the safe use of the product, the operator must ensure that all affected consumers who can be identified are informed directly and without undue delay of the withdrawal or safety warnings (personal data collected from customers may be used for this purpose). To ensure that consumers are properly informed of the withdrawal, the European Commission provides a template notice which includes the elements of the Regulation.
Where an economic operator has a product registration system or a customer loyalty scheme in place that allows the identification of products purchased by consumers, it is the responsibility of economic operators to offer their customers the possibility to provide separate contact details for product safety purposes only (personal data collected for this purpose must be kept to the minimum necessary and can only be used to contact consumers in the event of a withdrawal or safety warning).
Where it is not possible to contact all consumers concerned, it is the responsibility of economic operators to make a clear and visible announcement of the product recall or safety warning by other appropriate means to ensure the widest possible reach – typically through websites, social networks, newsletters and retail outlets, or as appropriate in the mass media and other means of communication.
The economic operator responsible for the withdrawal must also offer the consumer an effective, free and timely remedy. According to the Regulation, the consumer has three options under the conditions set out in the Regulation, namely to request:
- repair of the product,
- replacement of the product, or
- refund of the value of the product in a reasonable amount (but at least the price paid).
In general, the consumer should be allowed to choose at least two options for remedy, but there are exceptions. These concern situations where only one option is offered to the consumer because other remedies would not be possible or would cause disproportionate costs to the economic operator compared to the remedy proposed. However, the consumer is always entitled to a refund of the value of the product if the economic operator has not completed the repair or replacement within a reasonable time and without significant inconvenience to the consumer.
It should be noted that, according to the Regulation, the remedy must not cause significant inconvenience to the consumer. Therefore, the consumer must not bear the cost of sending the product back or returning it by other means. For products that are not inherently portable, the trader is obliged to ensure the removal of the product.
Special obligations in the case of distance selling
The Regulation lays down special rules for distance selling (typically online via an e-shop). Economic operators are now required to provide at least the following information in a clear and prominent manner in the pre-contractual offer of the product:
- identification and contact details of the manufacturer or the person responsible within the EU (name, registered trade name or registered trademark of the manufacturer and postal and electronic address where the manufacturer can be contacted),
- data enabling the product to be identified, including its picture and type and any other product identifiers, as well as
- any comprehensible warning or safety information to be attached to the product or its packaging (in the Czech language).
Specific obligations of online marketplace providers
Concerning online marketplace providers, the Regulation addresses those in some detail. A selection of these obligations can be listed below.
Online marketplace providers are now required to register on the Safety Gate portal introduced by the EU Regulation. They must also establish two single points of contact for direct communication on product safety – one for market surveillance authorities and one for the public, i.e. in particular consumers.
As a precaution against product unsafety, online marketplace providers are obliged to implement internal product safety processes and to randomly check the products on offer for compliance with the Regulation. Public databases such as the aforementioned Safety Gate early warning system can be used for this purpose.
Like other economic operators, online marketplace providers must properly notify consumers and the relevant economic operators (or manufacturers) of product withdrawals as well as inform the surveillance authorities.
The role of the European Commission in market surveillance and its implementation
The Regulation entrusts the enforcement of EU product safety rules primarily to the national market surveillance authorities of each Member State, which may cooperate with other public authorities as well as with economic operators or consumer organisations. The Commission then coordinates a network of national consumer safety authorities to facilitate the regular exchange of information, expertise, practices and enforcement of product safety in order to ensure balanced surveillance. The Commission also organises joint surveillance projects (e.g. simultaneous coordinated inspection actions to ensure product compliance with the Regulation – so-called sweeps).
Transposition of the Regulation into Czech law
The Regulation itself is directly applicable in the Czech Republic. However, Member States have until 13 December 2024 to ensure that the relevant legislation is adopted so that national laws comply with the Regulation. In addition, the national legislation must cover areas that the Regulation itself has left to the Member States to determine or specify – typically the division of powers and competences between national authorities or the definition of penalties for breach of obligations under the Regulation.
In the Czech Republic, this “adaptation” legislation should be the new Act on General Product Safety and Amendments to Other Regulations (the “Proposal”), which has already been approved by the Parliament of the Czech Republic and on 25 November 2024 was submitted to the President of the Czech Republic for signature, with an expected effective date identical to the Regulation – i.e. as of 13 December 2024 (the approved text of the Act can be found here).
Among other things, the draft establishes and specifies the designation of Czech public authorities within the scope of competence envisaged by the Regulation and the division of their tasks and powers under the Regulation among themselves. Supervision of general product safety will be carried out by the surveillance authorities within the scope of their competence provided for by specific legislation (e.g. the Czech Trade Inspectorate, the Czech State Agricultural and Food Inspection Authority, regional sanitary stations and others). Unless a specific body is specifically designated to carry out supervision, supervision in this area will fall to the Czech Trade Inspectorate. At the same time, the Proposal envisages strengthening the role and competences of the Ministry of Industry and Trade of the Czech Republic.
The proposal also lists specific offences for breaches of the Regulation or the Act, as well as the amount of penalties (fines) for individual offences. According to the Regulation, the sanctions should be effective, proportionate and dissuasive. Therefore, it is not surprising from the approved wording of the Proposal that for the defined offences economic operators risk penalties with an exposure of up to CZK 50,000,000 (however, most penalties for offences are below the maximum exposure of several million CZK).
Conclusion
The new comprehensive general product safety rules introduced by the Regulation, accompanied by national legislation, bring a whole new set of obligations to which many operators will have to respond, throughout the entire production and supply chain of consumer goods. At the same time, it can be expected that this area will also receive increased attention from the surveillance authorities in the near future, and therefore the operators concerned, in particular manufacturers, importers and distributors of goods, need to pay due attention to adapting to the new obligations. Failure to do so exposes them to the risk of potentially significant sanctions by the surveillance authorities.
We reiterate that the new obligations under the Regulation apply as of 13 December 2024, and therefore the time for preparation is already considerably short.
If you have any questions on this topic or any other consumer law issue, please do not hesitate to contact us.
JUDr. Miloš Kulda, Ph.D., attorney – kulda@plegal.cz
Mgr. Kateřina Vyšínová, junior lawyer – vysinova@plegal.cz
Rozálie Polášková, legal assistant – polaskova@plegal.cz
28. 11. 2024