After years of discussion, the EU has published its new draft Regulation on general product safety (GPSR). The GPSR seeks to address deficiencies identified in the current regulatory framework governing the safety of non-food consumer products, as part of the European Commission’s evaluation of the General Product Safety Directive 2001/95/EC (GPSD). Issues were identified in relation to traceability, market surveillance and product recalls, as well as the increasing digitalisation of retail and connectivity of electrical and electronic consumer products.
In particular, the GPSR’s new definition of a ‘product’ to include interconnectivity reflects the profound shift in the scope of products now available to consumers, compared to when the GPSD came into effect almost twenty years ago. The GPSR provides a new regulatory framework that is consistent with more recent EU legislative and policy goals, such as the EU Circular Economy Action Plan, the EU Digital Services Act, the EU Chemicals Strategy for Sustainability and its recent proposal for an Artificial Intelligence Act. Additionally, the GPSR will also repeal the current EU Directive on food-imitating products (Directive 87/357/EEC) and integrate its provisions so that they will be enforced in a more harmonised way by the Member States.
Application & scope
The GPSR is proposed to apply to all products defined in Article 3(1) as being ‘…any item, interconnected or not to other items, supplied or made available, whether for consideration or not, in the course of a commercial activity including in the context of providing a service – which is intended for consumers or can, under reasonably foreseeable conditions, be used by consumers even if not intended for them’. The GPSR is not proposed to apply to products that are regulated by separate EU legislation, such as medical devices, medicines and food. This definition of ‘product’ is inclusive of second-hand, refurbished, reused and recycled products. The recitals to the GPSR also make clear that specific cybersecurity risks presented by interconnected products should be dealt with in separate, sectoral legislation.
The GPSR proposes to introduce a new and broad legal definition of ‘online marketplace’ to reflect the digitalisation of the retail sector, which will mean ‘…a provider of an intermediary service using software, including a website, part of a website or an application, operated by or on behalf of a trader, which allows consumers to conclude distance contracts with other traders or consumers for the sale of products covered by [GPSR]’. Similarly, the GPSR explicitly addresses distance sales separately in Article 4. This is in contrast to the inclusion of online and electronic selling within the scope of recital 7 in the GPSD.
In order to determine whether the GPSR will apply to a particular online transaction, economic operators should take non-exhaustive criteria into account on:
• The use of an official language or currency of the Member States
• The use of a domain name registered in one of the Member States
• The geographical areas to which the products can be dispatched
Criteria for assessing product safety
On the issue of safety, where a product conforms to European standards, the GPSR offers a presumption of conformity with the general safety requirements or, in the absence of such standards, to health and safety requirements prescribed by Member State law. Article 6(3) of the GPSR, however, makes clear that such conformity will not prevent market surveillance authorities from taking action where a product is considered dangerous. Where the presumption of conformity does not apply, the determination of whether or not a product is safe involves the assessment of nine detailed criteria:
• The characteristics of the product, including its design, technical features, composition, packaging, instructions for assembly and installation and maintenance (where applicable)
• Its effect on other products, where reasonably foreseeable that it will be used with them
• The effect that other products might have on the product
• The presentation of the product, its labelling, any warnings and instructions for its safe use and disposal, and any other indication or information
• The categories of consumers at risk when using the product, particularly vulnerable consumers
• The appearance of the product and in particular, where a product, although not foodstuff, resembles foodstuff and is likely to be confused for food
• The fact that, although not designed or intended for use by children, the product resembles an object commonly recognised as appealing to or intended for use by children
• The cybersecurity features necessary to protect the product against external influences, which might impact its safety
• The evolving, learning and predictive functionalities of a product
The GPSR introduces new criteria for assessing product safety arising from advances in electrical and electronic products. It also proposes to apply stricter traceability requirements, to be adopted by a separate delegated act, for products that are likely to pose a serious risk to people’s health and safety.
General obligations of economic operators
Economic operators are subject to general obligations under the GPSR to ensure the safety of products. Notably, the GPSR proposes the introduction of a new requirement on substantial modifications, whereby responsibility for the safety of a product will lie with the person making the modification. The GPSR also extends the concept of an EU-based ‘responsible person’, as seen in other EU legislation, to non-harmonised products. This aims to address direct imports from third countries.
Safety gate notification system
The GPSR lifts and adapts sections of the MSR to create a single surveillance regime for both harmonised and non-harmonised products. Another significant development in the proposed new legislation is the rebranding of the RAPEX product safety notification system to ‘Safety Gate’. Although the structure of the notification system is unchanged, Member States will have two working days to notify corrective measures via Safety Gate, whereas the obligation to notify such measures via RAPEX fell due ‘immediately’. Consumers will also be able to review warnings and recall information issued by economic operators on the Safety Gate system.
Voluntary arbitration mechanism
The GPSR also introduces a new voluntary arbitration mechanism between Member States. Under this mechanism, the European Commission can make a decision on the level of risk presented by a product where there are diverging risk assessments.
The GPSR represents a new era in product safety law. This is not only in terms of the broader scope of products subject to regulation, but also that retail is no longer confined to bricks and mortar, or even distance selling, but has expanded to include a global online consumer experience. Although many of its requirements are similar to those under the GPSD, the new legislation contains enhanced and detailed requirements. It is recommended that companies identify their obligations under the proposed legislation well in advance of its application.
For more information, contact a member of our Product Regulation & Consumer Law team.
The content of this article is provided for information purposes only and does not constitute legal or other advice.