General Product Safety Regulation – new requirements for the entrepreneurs in practice

Publication date: January 28, 2025

What does the Regulation concern?

From 13.12.2024 there came into force in Poland, the provisions of Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and of the Council and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC (OJ EU. L. of 2023, No. 135, p. 1), hereinafter referred to as the “GPSR Regulation”. The abbreviation comes from the words General Product Safety Regulation. This legal act replaced the General Product Safety Directive (GPSD) from 2001, which, due to the enormous technological progress and the increased share of online sales on the market, has become outdated in the opinion of the EU legislator. The focus was on the unification of legal provisions, because the provisions were included in a regulation, which is binding in its entirety and directly applicable in all Member States, and therefore does not require implementation, e.g. by means of a separate statute.

First of all, it is necessary to answer the question of what subject matter is regulated by the GPSR Regulation. Article 2(1) states that its provisions apply to products that are placed on the market or made available on the market, to the extent that EU law does not contain specific provisions with the same purpose that regulate the safety of the products in question. The above provision states that the GPSR Regulation is a general regulation in the context of all products that can be obtained on the consumer market. These will be goods purchased by the model consumer, i.e., for example, toys or electronic equipment. The catalogue of these products is open. Article 2(2) of the discussed article specifies products that are not subject to the requirements resulting from the GPSR Regulation – these are, for example, medicinal products for human use, food, feed, live plants and animals and antiques. According to Article 2(3), the GPSR Regulation applies not only to new products, but also to used, repaired or refurbished products. However, the provisions will not apply to products requiring repair or refurbishment if such information is included after the goods have been placed on the market.

Before discussing the provisions of the GPSR Regulation in detail, attention should be drawn to its Article 51, which specifies that if a product has been made available on the product market in accordance with the GPSD and before 13.12.2024, it may continue to be traded after the provisions of this Regulation enter into force. This solution seems to be correct in terms of the security of trade and the principle of non-retroactivity of the law. The provision will be of particular importance in the matter of selling products over the Internet – this topic will be developed in more detail later.

Safety requirements

Chapter II of the GPSR Regulation concerns the safety requirements that products must meet in order to comply with the law. According to Article 5, economic operators may only place or make available on the market safe products. The text of the legal act clearly differentiates between “placing on the market” and “making available on the market”, therefore it is necessary to refer to the definitions contained in Article 3 of the GPSR Regulation:

1. Point 6 – “making available on the market” means supplying a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.
2. Point 7 – “placing on the market” means making a product available on the EU market for the first time.

The product must be safe, which according to Article 3, point 2 means that the product in question, under normal or reasonably foreseeable conditions of use, including the actual time of use, does not present any risk or only a minimal risk consistent with its use, considered acceptable and corresponding to a high level of protection of consumer health and safety. However, in order to consider a product safe, the requirements set out in the GPSR Regulation must be met. Article 6 lists a number of criteria taken into account when assessing safety:

1. Product characteristics The key characteristics of the product are taken into account, such as: design, technical characteristics, composition, packaging, as well as any instructions related to assembly, installation, use and maintenance, if required.
2. Impact of interactions with other products The impact that the product may have on other products with which it is used is analyzed. In particular, this concerns the anticipated connections with other products and the impact on their performance or safety, including non-integrated elements that may change the way the product under assessment functions.
3. How the product is presented It is assessed whether the product is appropriately presented to the consumer, taking into account: product labelling (e.g. whether the product can be used by children of a given age, any warnings), instructions for safe use and disposal, and other information relevant to the consumer.
4. Product User Category The specific needs and potential risks for children, the elderly, and people with disabilities are taken into account . Gender differences that may affect health and safety are also taken into account.
5. Product appearance and risk of misuse It is assessed whether the appearance of the product may induce consumers to misuse it, especially when the product resembles food (e.g. due to its shape, smell, colour or packaging), which may lead to a risk of accidental ingestion by consumers, especially children, and whether the product, although not intended for children, may be used by them when it looks attractive to this age group.
6. Product cybersecurity If the product requires it, it is assessed whether it has appropriate mechanisms to protect against external threats, and above all, against the actions of third parties with malicious intent who use the IT system for this purpose.
7. Advanced Product Features In the case of products equipped with learning, predictive or evolving features, the impact of these technologies on user safety is analyzed. In this case, it will primarily be about artificial intelligence systems.

With respect to the GPSD, the EU legislator has broadened the scope of the criteria described above. New aspects include the appearance of the product and, most importantly, cybersecurity functions and products equipped with self-learning functions. It is the second and third elements that seem to be the most important changes compared to the previous legal status. In recent years, the European Union has been strongly focusing on the issues of computerization and artificial intelligence. Drawing attention to the possibility of damage caused by cyberattacks is right due to the security of economic turnover and, above all, consumers. The AI Act regulation applies to artificial intelligence, which largely regulates the use of AI systems – for example, it explicitly lists prohibited practices. The assessment of the safety of the product should start at the design stage and cover the entire period of its use.

Article 7 of the GPSR also helps to determine whether a given product is safe, as it provides information on the presumption of conformity with the general safety requirement. Based on its content, a product is considered to be in compliance with the general safety requirement if it complies with European standards published in the Official Journal of the European Union or if there are no relevant European standards and the product meets the requirements in relation to the risks covered by the health and safety requirements specified in the national law of the Member State in which the product is made available. However, the condition is that the national law complies with European Union law. The presumption of conformity with the general safety requirement does not mean that the existence of the product on the market cannot be questioned. Supervisory authorities have the right to take appropriate action if there is evidence that, despite meeting the criteria for presumption of conformity, the product is dangerous. This means that even products that comply with European standards or national requirements may be withdrawn or controlled.

Obligations of economic entities

The obligations of economic entities are regulated in Chapter III of the GPSR Regulation. The provisions of this Chapter impose specific obligations on entrepreneurs. First, it is necessary to refer to the definitions set out in Article 3 of the GPSR Regulation to familiarize with who the Regulation applies to:

1. Point 8 – “manufacturer” means any natural or legal person who manufactures a product or has a product designed or manufactured and sells that product under his name or trademark.
2. Point 9 – “authorised representative” means any natural or legal person established in the Union who has received a written mandate from a manufacturer to act on his behalf with regard to specified tasks in relation to the manufacturer’s obligations under this Regulation.
3. Point 10 – “importer” means any natural or legal person established in the Union who places a product from a third country on the Union market.
4. Point 11 – “distributor” means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.

For each of the entities mentioned above, a separate regulation provides for different requirements, which will be discussed in detail.

Article 9 of the GPSR Regulation specifies the obligations of manufacturers. According to this provision, manufacturers must, in particular, design and manufacture products in accordance with the general safety requirements, conduct a risk analysis and prepare technical documentation describing the key characteristics of the product. This documentation should be updated and kept for 10 years so that it is available to market surveillance authorities upon request. Products must be appropriately marked and the manufacturer is obliged to provide clear instructions and safety information in a language that consumers can understand. If risks associated with a product are identified, the manufacturer must take immediate corrective measures (e.g. withdraw the product from the market) and inform consumers and surveillance authorities via the Safety Business Gateway. This is an online portal that allows information on dangerous products and accidents to be shared with consumers and market surveillance authorities – according to recital 68 of the GPSR Regulation, appropriate notification is mandatory and should be made without undue delay. Additionally, manufacturers should keep a register of complaints and incidents, investigate reported problems and inform the supply chain about them.

According to Article 10 of the GPSR Regulation, the manufacturer may appoint an authorised representative by granting him/her a written authorisation specifying the scope of his/her tasks. As part of his/her duties, the representative is obliged to provide the necessary information and documents confirming the safety of the product upon request of the market surveillance authorities. In the event of justified doubts, the representative should immediately inform the manufacturer and, if necessary, report corrective actions on the Safety Business Gateway portal, unless they have already been taken by the manufacturer. Additionally, the authorised representative cooperates with the relevant national authorities in eliminating risks related to the products included in his/her authorisation. The authorisation allows the authorised representative to perform at least the tasks presented above, which means that it is possible to extend the scope of his/her activities to include actions not indicated in this provision.

The regulations concerning the importer are included in Article 11 of the GPSR Regulation. Before a product is placed on the market, the importer must ensure that the product meets the general safety requirements and that the manufacturer has fulfilled its obligations regarding documentation, labelling and product information. In the event of any doubts as to the product’s compliance with the requirements, the importer is obliged to suspend its introduction to the market until the matter is resolved. If the product proves to be unsafe, the importer must immediately inform the manufacturer, market surveillance authorities and take corrective measures (e.g. product withdrawal). Importers must also ensure appropriate conditions for the storage and transport of the product. In addition, they cooperate with supervisory authorities and manufacturers to eliminate risks – if they become aware of an accident caused by the product, they must immediately notify the manufacturer and the market surveillance authorities of the Member States in which the product was made available on the market, via the Safety Business Gateway portal.

Article 12 of the GPSR regulation concerns the distributor. The regulation refers to certain regulations concerning the manufacturer and importer – the distributor must be certain that these two entities have met the safety requirements. In addition, the distributor must take care of the transport and storage conditions of the product. If the product proves to be non-compliant with the requirements resulting from the regulation, the distributor cannot make the product available on the market until it complies with the law. The product may also prove to be dangerous – in such a case, the distributor should notify the importer or manufacturer of the fact and ensure that the supervisory authorities are informed about it via the Safety Business Gateway.

The previous legal status did not provide for such extensive provisions concerning each of the mentioned entities. – GPSD only specified the obligations of producers and distributors, being silent on the subject of the authorized representative, importer and the system for reporting irregularities via the Safety Business Gateway portal. There is a visible stricter regulation of obligations resulting from the introduction of products to the market, which is certainly related to consumer protection.

Distance selling – online trading

The biggest novelty in the GPSR regulation is the introduction of additional provisions directly related to the making available of products on the market via the Internet. The obligations of economic operators regarding the offer of distance selling are specified in Article 19 of the GPSR regulation. At least the following markings must be included:

1. Name and surname, registered trade name or registered trademark of the manufacturer and the postal and e-mail address at which it can be contacted.
2. Where the manufacturer is not established in the Union – the name and surname or business name, postal and e-mail address of the responsible person. The responsible person may be, in accordance with Article 4 of Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ EU. L. of 2019, No. 169, p. 1, as amended) an economic operator established in the European Union responsible for specific tasks. The provision also lists examples of entities that may be the responsible person, which are: a manufacturer based in the EU – when it manufactures and places the product on the market itself, an importer – if the manufacturer is not based in the EU, an authorised representative – with written authorisation from the manufacturer to act on its behalf, an order fulfilment service provider – if none of the previously mentioned entities operate in the EU.
3. Personally identifiable product information, including product image, type, and other product identifiers.
4. Any warnings or safety information required to appear on the product or its packaging or in an accompanying document in accordance with this Regulation or with applicable Union harmonisation legislation, in a language which can be easily understood by consumers as determined by the Member State in which the product is made available on the market.

Due to the fact that the consumer cannot physically familiarize themselves with the product, the EU legislator decided to significantly interfere with the appropriate markings. It seems that this was dictated by consumer protection. The European Union rightly paid special attention to the online sector due to the growing popularity of this medium. The new regulations will certainly help to eliminate certain harmful practices for trade and for consumers themselves conducted via the Internet.

In addition, the GPSR regulation in Article 22 provides for obligations for providers of online marketplaces. The definition of this entity is set out in Article 3, point 14 – it is a provider of an intermediation service using an online interface that allows consumers to conclude distance contracts with entrepreneurs for the sale of products. It is indicated that the definition is so broad that it will not only apply to large companies such as Amazon or eBay, but also smaller companies that engage in dropshipping.

The provision cited at the beginning of the previous paragraph states that providers of online marketplaces shall designate a single point of contact enabling direct electronic communication with the market surveillance authorities of the Member States on product safety issues . To this end, they must register on the Safety Gate portal and provide the relevant contact information, which must also be available to consumers. In addition, providers of online marketplaces shall ensure that internal procedures concerning product safety are in place. This obligation does not rest solely with the economic operators indicated in the previous part of the argument. The provider must have extensive knowledge of the manufacturer and the products sold on its website.

The provision in question also specifies the situation concerning the issuance of an order obliging providers of online trading platforms to remove an offer for the sale of a dangerous product from their website by market surveillance authorities. The deadline for executing this order is 3 business days from the date of its receipt. Moreover, providers are obliged to cooperate closely with supervisory authorities and entrepreneurs, among others by informing consumers about corrective actions, reporting incidents related to products or supporting actions related to the recovery of dangerous products.

Sanctions for violating the provisions of the regulation

Article 44 of the GPSR Regulation specifies that Member States are empowered to lay down appropriate rules on penalties applicable to infringements of this Regulation, which impose obligations on economic operators and providers of online marketplaces, and shall take all measures to ensure that these provisions are implemented in accordance with national law. The EU legislator, despite regulating the issue of product safety in the Regulation, has given Member States a free hand in this respect – each of them should therefore adopt appropriate provisions. Paragraph 2 of the provision in question states that the penalties provided for must be effective, proportionate and dissuasive. The Regulation introduced basically the same regulation as was present in the GPSD Directive.

A new act has been proposed, which is intended to introduce appropriate regulations. However, it should be remembered that this is a draft. It will replace the old one – adapted to the GPSD. The administrative penalty is imposed in the amount of PLN 40,000 to PLN 1 million – the maximum penalty is very high. In relation to the currently applicable act, the scope of entities that may be required to pay a fine has been extended to include importers or suppliers of online trading platforms. All this in order to meet the requirements resulting from the GPSR regulation. However, the amount was determined solely by the Polish drafters – the only requirement resulting from the EU act is for the penalties to be effective.

Summary

The GPSR regulation certainly introduces many changes to the legal systems of the European Union countries. Consumer protection and product safety seem to be key issues for the EU legislator. The regulations interfere very strongly with economic turnover, as entities participating in it are subject to many obligations. The Safe Gate system will certainly make it easier for supervisory authorities to effectively combat any non-compliance. However, greater interference in turnover may result in additional costs for entrepreneurs, such as paying high fines, adjusting the description and content of the product or appropriate preparation of the website.