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European Commission publishes guidelines on General Product Safety Regulation

On 19 November 2025 the European Commission published guidelines for the General Product Safety Regulation (GPSR), offering clarity for businesses on the rules effective since December 2024, which mandate safer products, digital info, EU responsible persons, and enhanced online marketplace duties, aiming to create a safety net for all non-food consumer goods in the EU and modernise rules for AI/IoT.

These guidelines, alongside a Safety Business Gateway portal, help economic operators meet obligations like risk assessments, technical documentation, and effective recalls, ensuring compliance across online and physical sales.

While much of the information provided in the Guidelines will come as no surprise to businesses, they serve as a helpful reminder, one year post the application of the GPSR, of the ongoing obligations placed upon businesses bringing products to the EU market.

Background

The GPSR introduced significant updates to the EU’s framework for the safety of consumer products to account for technological developments and the proliferation of online selling.  Article 17(2) of the GPSR required the European Commission to publish the Guidelines and, they provide welcome guidance for businesses on how to fulfil their obligations under the new regulation.  While aimed particularly at SMEs, the Guidelines apply to all businesses in scope of the GPSR.

The GPSR’s notification and recall requirements complement the EU Product Liability Directive by creating transparency about product safety issues, which may also inform potential liability claims.  Both frameworks share the common objective of consumer protection whilst serving different but mutually reinforcing functions within the EU’s product safety architecture.  Ireland is required to implement the EU Product Liability Directive on or before 9 December 2026.  For further detail on the EU Product Liability Directive please see our previous insight here.

Overview of the GPSR

The GPSR aims to ensure that only safe products are placed or made available on the EU market.  To achieve this, the GPSR establishes a set of minimum product safety requirements that businesses must comply with.

The GPSR imposes obligations on “economic operators” (e.g. manufacturers, authorised representatives, importers, distributors and fulfilment service providers) with respect to assessing their products for risks, preparing appropriate technical documentation, establishing internal processes to maintain product safety and taking corrective measures if safety issues arise.  Providers of online marketplaces are also subject to obligations under the GPSR.

Market Surveillance Authorities (“MSAs”) within Member States, are responsible for enforcing the GPSR, for example, the Competition and Consumer Protection Commission in Ireland.  Businesses which fail to comply with their obligations under the GPSR may be guilty of a criminal offence and can be subject to prohibition notices and / or fines.

Perhaps the most useful feature of the Guidelines is the provision of individual checklists for each category of economic operator and providers of an online marketplace.  These checklists set out, at a high level, the considerations and actions to be taken to ensure compliance with the GPSR.  For example, the checklist for manufacturers contains 13 items ranging from product design considerations to packaging requirements and safety issues.

Clarifications in the Guidelines

EU Harmonised Legislation:  The Guidelines clarify that the GPSR complements existing EU harmonising legislation and applies only insofar as products are not covered by pre-existing EU legislation.  Where products are subject to pre-existing risk requirements, the GPSR only applies to areas of risk which have not been covered by those requirements, for example, low risk AI products not covered by the EU AI Act or low voltage devices not covered by the EU Low Voltage Directive.

Meaning of “Product” under the GPSR:  The GPSR broadly defines a “Product” as “any item whether or not it is interconnected to other items.”  The Guidelines clarify that this encompasses apps and software products such as chatbots.  Second-hand and refurbished products are also in-scope irrespective of the sales channel used.

Responsible Person:  Products covered by the GPSR cannot be placed on the market unless an economic operator established within the EU is designated as a “responsible person”.  The Guidelines have clarified that a “responsible person” can be any of the following: (a) a manufacturer established in the EU; (b) an importer if the manufacturer is not established in the EU; (c) an authorised representative of the manufacturer, and; (d) a fulfilment service provider established in the EU if no importer, manufacturer or authorised representative is established in the EU.

Consideration of mental health in risk assessment:  While the recitals to the GPSR contain a passing reference to mental health in the context of the risk assessment to be carried out in respect of products, this is further developed in the Guidelines which provides that the design and the foreseen use of the product should not create risks for consumers’ cognitive abilities or cause depression, anxiety or poor sleep quality.

Use of the Safety Business Gateway:  The GPSR rebranded the RAPEX system (relating to dangerous products) and modernised it into what is now called Safety Gate.  The system continues to serve the same fundamental purpose i.e. enabling rapid information exchange between EU Member States and MSAs about dangerous products.  Under the GPSR, Safety Gate comprises of three elements:

  • The Safety Gate Rapid Alert System (the successor to RAPEX) for authorities;
  • The Safety Gate Portal to inform the public and enable them to submit complaints; and
  • The Safety Business Gateway for businesses to report dangerous products and accidents to MSAs and consumers.

The Guidelines provide practical tips for businesses in terms of how to create an account and what information to enter into the Safety Business Gateway.  In addition to the Guidelines, the European Commission also published an eight page guideline for the practical implementation of the Safety Business Gateway.

Product recalls:  The Guidelines clarify the GPSR obligation to make recall information accessible to persons with disabilities.  When important information about a recalled product is contained in an image, it must also be provided in machine-readable text format.  Images should allow for flexible adjustments in magnification, brightness and contrast, and ensure interoperability with assistive programmes and devices.

Contact

If you have any questions about this update, please contact partners Julie Murphy-O’Connor, Michael Byrne, and Ruadhán Kenny, senior associates Ellen Cummins, and Ian Cusack or your usual Matheson contact.

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