The EU's new General Product Safety Regulation (GPSR) represents a major shift in the way product safety is governed across multiple sectors within the internal market. 

Replacing the previous 2001 Directive, the GPSR modernizes safety requirements to reflect new technologies, e-commerce, and cross-border trade. It imposes stricter obligations on manufacturers, importers, and online marketplaces to ensure product traceability, risk management, and rapid response to safety concerns. Businesses operating in the EU must now align their compliance strategies to meet these updated requirements.

This article offers a practical overview of the GPSR’s scope, applicability, and compliance obligations across the entire product supply chain—from manufacturers and importers to distributors, fulfilment service providers, and online marketplaces. It outlines the new labelling, risk assessment, and traceability requirements, as well as the reinforced consumer recall and remedy procedures. Special attention is given to the GPSR’s impact on e-commerce, connected devices, and non-EU businesses, particularly SMEs that now face stricter access requirements to the EU market

This article is written by Sefa Geçikli ([email protected]) and Lorena Velo ([email protected]). Sefa and Lorena are part of RSM Netherlands Business Consulting Services, specifically focusing on International Trade and Strategy. 

Scope and Applicability 

The GPSR entered into force on 12 June 2023 and is applicable from 13 December 2024 across all EU and EEA Member States. As a regulation rather than a directive, it is directly applicable without the need for national implementation laws creating a more harmonized framework. The new Regulation aims to keep up with the challenges of digitalization and the increasing amount of goods and products sold online. The Regulation applies to all consumer products placed on the EU market unless those products fall under specific EU legislation such as food, cosmetics, toys, and medicines, which remain subject to their own sector-specific legislation. Therefore, the GPSR will apply to a wide range of others, including connected devices, household goods, electronics, and general consumer items. Importantly, it also applies to new, used, repaired, or reconditioned products, a notable expansion from previous rules.

Obligations for economic operators in the supply chain 

Manufacturers 

Obligations under the GPSR are extensive and affect nearly every actor in the product supply chain. Manufacturers must ensure that their products are safe and include updated technical documentation, risk assessments, test reports, clear usage instructions, and appropriate labelling. Labelling must contain product type, batch or serial number, manufacturer’s name or trade name, postal and electronic addresses, warnings, and information regarding age suitability for children. If the manufacturer is located outside the EU, this information must instead include the contact details of the designated importer or authorized representative within the Union. Furthermore, all manufacturers of non-food consumer products must appoint a responsible person in the EU either an importer, distributor, authorized representative or fulfilment service provider to ensure compliance with the regulation.

Importers 

Importers must refuse to place on the market any product that does not meet safety requirements. They should provide contact details on the products and check that they are accompanied by clear instructions and safety information. Importers are required to take responsibility for the items in their care during transport and storage, while informing manufacturers and national market surveillance authorities, through the Safety Business Gateway, if there is a reason to believe a product is dangerous. Fulfilment service providers are also responsible for the safety of products in their care, particularly when no other responsible party is established within the EU.

Distributors 

Distributors in the EU must ensure that manufacturers and, where applicable, importers comply with the regulation’s requirements, refusing to place on the market any products they consider do not meet these requirements. The obligations extend to informing  manufacturers, importers, and national surveillance authorities, through the Safety Business Gateway, if there is a reason to believe a product is dangerous and ensure suitable action is taken.

Online marketplaces

The GPSR also imposes unique obligations on online marketplaces such as Amazon. These platforms are required to cooperate with market surveillance authorities, adopting internal product safety processes and conducting random checks to ensure compliance. Marketplaces are obliged to register with the Safety Gate portal, establish a single point of contact for authorities and consumers, and respond to inquiries within two working days. They must also display safety warnings, provide manufacturer contact details, notify authorities of dangerous products, and advertise recalls, directly contacting affected consumers when necessary.

Therefore, the Safety Gate now holds a central role not only in alerting authorities to risks but also in coordinating cross-border responses to safety threats. The regulation introduces obligations for all aforementioned economic operators to assess risks such as mechanical, chemical, and electrical hazards and also new categories such as cybersecurity threats. 

Product recalls and consumer remedies

In terms of consumer protection, the GPSR has updated recall and remedy procedures. Economic operators must offer consumers a choice of two out of three options in the case of a recall: a full refund equal to the purchase price, a replacement, or a repair. If a repair or replacement is not possible or is disproportionate, a full refund must be offered. Recall notices must be clear and actionable, without misleading language such as “voluntary” or “precautionary.” Businesses must proactively notify affected consumers using available personal data and advertise recalls across multiple channels, including websites, social media, and retail outlets. These steps must also accommodate consumers with disabilities, reinforcing the regulation’s inclusive approach to safety communication.

How will businesses be affected: 

The impact of the GPSR will vary by sector but certain industries will face more significant compliance demands. For instance, electronics, consumer tech, smart appliances and e-commerce sellers are among the most affected. These sectors deal frequently with cross-border shipments and connected functionalities, which makes them more vulnerable to regulatory scrutiny. Businesses dealing in general consumer goods that are not governed by harmonized EU legislation must now prepare for stricter requirements  such as safety checks through risk assessments, labelling, traceability and technical documentation. Conversely, sectors like pharmaceuticals, food and toys will largely continue under their respective sector-specific legislations, although certain product may require cross-checking of both regulatory regimes for aspects, such as packaging or online sales.

An important consideration often overlooked is the disproportionate compliance burden the GPSR may place on small and medium-sized enterprises (SMEs), particularly those based outside the EU. SMEs exporting to the EU now face complex logistical and legal challenges, including the mandatory appointment of an EU-based authorized representative and the creation of detailed technical documentation and safety labeling in line with EU standards. These requirements, while crucial for consumer safety, may lead to increased operational costs and administrative strain for smaller firms with limited resources. Some UK SMEs, for instance, have reportedly halted EU sales due to lack of preparedness and regulatory clarity.

Looking forward

As the regulatory environment becomes stricter under the General Product Safety Regulation, businesses operating in the EU are required to adjust their internal systems and market strategies to remain compliant and competitive in the online marketplace. For manufacturers, this will require investing in product safety by design, ensuring accurate technical documentation by collaborating with different experts and teams and use traceability tools to monitor the product’s supply chain. Importers and distributors must refine quality assurance processes, ensure clear labeling and be prepared to engage directly with national authorities through the Safety Business Gateway. Fulfilment service providers, which are classified as economic operators under the GPSR, and online marketplaces must implement dedicated compliance teams, conduct safety checks and respond swiftly to regulatory inquiries and consumer safety incidents.

Moreover, non-EU businesses seeking to access the EU market must designate authorized representatives within the Union and restructure their distribution networks to accommodate GPSR requirements. Failure to do so could result in limited or non-existent market access, reputational harm and financial penalties by national authorities. Considering that connected devices and e-commerce continue to rise, cybersecurity, accident reporting, and digital traceability will become essential features of compliant operations with obligations deriving not only from GPSR, but also navigation through sector-specific legislation and other frameworks such as the Data Act and the Cyber Resilience Act that may be applicable to certain aspects of the products. 

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