General Product Safety Regulation
General Product Safety Regulation (EU) 2023/988 (GPSR): Requirements, Obligations and Product Safety for Consumer Products
Introduction to the RoHS Directive 2011/65/EU
Objectives of the General Product Safety Regulation and Significance for Product Safety in the EU
The European General Product Safety Regulation (GPSR) establishes a uniformly high level of protection for the health of end consumers throughout the European single market. This groundbreaking EU Regulation ensures that new, technologically complex products also comply with standardised safety requirements. This harmonises the legal conditions for the free movement of non-food goods and strengthens buyers’ trust in the integrity of the European trading area in the long term.
Replacement of Previous Regulations and Relationship to the Product Safety Act (ProdSG)
As directly applicable Union law, the new set of rules completely replaces the outdated Directive 2001/95/EC on general product safety. For all economic operators concerned, primarily manufacturers, importers and distributors, the statutory transition period ended on 13 December 2024. Since no national deviations from the Community rules are permitted from this date onwards, every company concerned must have fully adapted its internal quality and release processes to the new legal framework.
Scope for Consumer Products and Economic Operators
The obligations extend across the board to all non-food consumer products made available on the market or supplied commercially to end users. This Regulation acts as a legal safety net: it applies whenever no more specific sectoral regulations exist that cover health protection to the same extent. Every consumer good placed on the market must offer the highest possible level of safety in everyday use in order to effectively rule out liability risks for those placing it on the market.
Scope of Application of the GPSR
Which Products and Consumer Products Fall Under the Regulation
The material scope covers classic consumer goods such as textiles, furniture, sports equipment and household goods that are specifically intended for consumers. The General Product Safety Regulation covers all distribution channels equally, placing traditional brick-and-mortar retail and modern digital distance selling on a completely equal legal footing. The aim is to raise the level of general product safety in all European Member States to a uniform, future-proof and fully verifiable level.
Exceptions and Special Product Types (e.g. Antiques)
Certain product segments are explicitly excluded from the scope by European legislation. These include medicinal products for human and veterinary use, food, feed and living plants. Genuine antiques and used items that are explicitly labelled as requiring repair or restoration constitute a special case for historical reasons. In such a constellation, the strict standard obligations do not apply in this specific case, provided that the goods demonstrably meet such criteria by their nature.
Distinction from Sector-Specific Union Harmonisation Legislation
The provisions of the legislation apply on a complementary basis. Where specific Union harmonisation legislation already applies to a product group, such as the CE directives for toys, medical devices or personal protective equipment, these special laws generally take precedence. Nevertheless, the accompanying obligations regarding comprehensive market surveillance, traceability in online trade and the general strategic requirements for all market participants involved remain fully in force as a binding minimum standard.
Obligations of Economic Operators
Manufacturer Obligations Under the General Product Safety Regulation
The manufacturer bears the ultimate, non-delegable responsibility for the conformity of the consumer goods it designs. Its core tasks include carrying out a precise, documented risk analysis and preparing complete technical documentation, which must be kept for ten years. In addition, the manufacturer is obliged to affix clear information for physical identification to the product, which includes not only a batch number but also its name, trade name or registered trade mark.
Tasks of Importers, Distributors and Authorised Representatives
When sourcing goods from third countries, an importer assumes far-reaching legal obligations and may only place products on the single market that demonstrably meet the applicable European safety requirements. It must check whether the foreign producer has fulfilled all technical requirements. The downstream distributor, in turn, acts as a control body: it must exercise commercial due care to prevent defective goods from being placed on the market.
Responsible Person Within the EU and Their Responsibilities
Under the new regulations, placing consumer goods on the market is strictly prohibited unless a market participant established in the Union has been designated as the responsible person. This strategic function can be performed by the EU manufacturer itself, an importer or an authorised representative mandated in writing. This natural or legal person is directly liable to the European market surveillance authorities and ensures that technical test reports can be submitted immediately if required.
Product Safety and Safety Requirements
Safety Requirements for Products Throughout the Entire Life Cycle
The criteria for conformity state that goods must not pose any risks to users when used as intended or in a reasonably foreseeable manner. The aspects assessed include the specific material composition, mechanical strength, chemical safety and interactions with other systems. Every company must verify these parameters mathematically and physically as early as the development phase in order to prevent official sanctions.
Risk Analysis and Risk Assessment as the Basis for Product Safety
A mathematical and logical risk analysis combined with a systematic risk assessment serves as the methodological foundation of product development. In this phase, potential mechanical, thermal or electrical hazard scenarios are precisely quantified and evaluated. The resulting document serves the party placing the product on the market as legally sound proof that all essential consumer protection requirements have been analysed and reduced to a minimum through design measures.
Identification of Potential Risks for Consumers
In the early, systematic identification of sources of danger, vulnerable groups of people such as young children, pregnant women or older people must be explicitly taken into account. Clear examples are the chemical release of plasticisers from plastics or the risk of strangulation posed by children’s clothing. Overlooking such target groups leads to existentially threatening liability consequences for the economic operators responsible in the event of damage and endangers the health of consumers.
Information Obligations and Product Labelling
Mandatory Information: Name, Trade Name, Trade Mark and Address
To enforce transparent market structures, the legislation requires strict compliance with extended information obligations. Every consumer good must be labelled with clear, permanent names. Specifically, this means physically affixing the manufacturer’s real name, registered trade name or legally protected trade mark. This labelling obligation enables supervisory authorities to trace the supply chain accurately during random inspections.
Postal Address, Contact Information and Identification of the Manufacturer
In addition to the brand features, it is a legal requirement to state a physical postal address of the manufacturer at which it can be served legal documents, either on the product itself or on its packaging. To take account of digital change, the authorities also require an electronic address, such as an email address or a specific support URL, to enable end consumers to make accessible, prompt and direct contact in the event of a complaint.
Requirements for Packaging, Labelling and Product Information
The logistics and sales packaging must be designed in such a way that all mandatory information for unambiguous identification (type, serial or batch number) is visible to customs even when the product is packaged. The following also applies to distance selling: every digital offer requires a high-resolution, true-colour image of the product so that customers can visually check safety features and labelling elements before completing their purchase.
Safety Information and Warnings
Providing Safety Information for Consumers in an Understandable Way
All instructive safety information, assembly instructions and operating instructions must be written in the official languages of the Member States in which the product is made available commercially. This is one of the most important regulatory requirements. The texts must be worded unambiguously for medical and technical laypersons and contain clear instructions for safe use, maintenance and dismantling.
Warnings and Notices for Safe Use
Explicit warnings (such as graphic pictograms or standardised signal words) must be affixed directly to the product if residual risks cannot be completely eliminated by design measures. A precise, high-contrast notice of age restrictions or safety distances to be observed protects users against physical injury and safeguards the distributing company in terms of liability against unfounded claims for damages.
Digital and Physical Provision of Safety-Relevant Information
The legal regulations stipulate that core safety-relevant data must be physically enclosed with the product in printed form. A mere reference to online resources is not permitted. However, parallel, complementary provision via modern digital interfaces (e.g. dynamic QR codes) is expressly encouraged in order to provide further multilingual video instructions or conformity documents in an accessible way.
Distance Selling and Online Trade
Requirements for Product Offers on Marketplaces and Online Shops
In online trade and in distance selling as a whole, stricter obligations under competition and product safety law apply to the design of digital product offers. Web shop operators may only activate sales pages once all legally required manufacturer markings and hazard warnings have been integrated directly in the user’s field of view. Concealing this data in the general terms and conditions (GTC) is not permitted.
Information Obligations in Distance Selling Under the GPSR
The specific information obligations in e-commerce require every product page on the internet to clearly display the exact name, postal address and a valid email address of the manufacturer and, if the manufacturer is based outside the EU, of the responsible person within the Union. These strict regulations eliminate anonymous direct imports from third countries and ensure that consumer protection authorities have immediate access.
Responsibilities of Marketplaces and Service Providers
European market surveillance holds B2B platforms, online marketplaces and modern fulfilment service providers strictly jointly liable. Under the GPSR, they act as independent economic operators. They must maintain dedicated digital reporting interfaces to the authorities and are legally obliged to completely remove illegal or dangerous sales offers from their platforms within a fixed deadline of no more than two working days.
Traceability and Market Surveillance
Identification of Products Along the Supply Chain
Complete, transparent traceability forms the strategic backbone of modern market surveillance. Economic operators must be able to fully document and demonstrate over a ten-year period from which suppliers they obtained a product and to which commercial customers they sold it. This complete chain for identifying trade routes makes it possible to immediately block contaminated or defective batches in the event of a crisis.
Documentation, Evidence and Cooperation with Authorities
The administrative obligations include keeping the complete conformity documentation available. In addition to technical design drawings and material certificates, this includes the official EU declaration of conformity and accredited test reports. Upon request, this evidence must be submitted electronically to the market surveillance authorities of the individual Member States within short deadlines in an official language that the authority can understand.
Measures in the Event of Safety Defects and Product Risks
If a party placing products on the market becomes aware that its products in circulation pose a real danger, an immediate notification obligation via Safety Gate (formerly RAPEX) applies. The company must immediately initiate effective corrective measures, proactively warn consumers and launch a logistical recall. Such a recall must, as standard, be completely free of charge and straightforward for the end consumer and be linked to fair compensation options.
Risk Management and Product Safety in Companies
Integration of Risk Analysis and Risk Assessment into Corporate Processes
For operational damage prevention, companies must implement compliance processes directly in their ERP and quality management systems. The preparation of a well-founded risk analysis and subsequent approval by means of a verified risk assessment must not take place in isolation, but must be anchored as a mandatory quality gate before every production start. Continuous audits ensure that technical changes to the product automatically trigger a reassessment.
Implementation of the GPSR Requirements in Practice
Small and medium-sized enterprises (SMEs) can cope with the high administrative workload through the targeted use of modular compliance software and standardised document templates. Bundling testing processes and working strategically with accredited testing laboratories helps to implement the complex requirements of the General Product Safety Regulation in a resource-efficient and cost-effective way, without building up massive bureaucratic overcapacities in-house.
Typical Sources of Error and Compliance Risks
The most common failings found during company inspections concern outdated address data, the absence of a registered trade mark in the EUIPO register or incorrect translations of warning texts. An internal compliance checklist that systematically checks all minimum legal features, the availability of the technical documents and the correct linking in the online shop before final customs clearance effectively protects companies against costly warning letters and official sales bans.
Differences Between the GPSR and Previous Product Safety Law
Changes Compared with the Product Safety Act (ProdSG)
At national level in Germany, the safety requirements were previously regulated primarily by the Product Safety Act (ProdSG). With the entry into force of the European Regulation, the core substantive areas of the ProdSG have largely been superseded, since an EU regulation, unlike a directive, has direct legal force. The national ProdSG now only remains in place on a complementary basis for specific national structures (such as the award of the GS mark) and official responsibilities.
New Requirements for Economic Operators, Distributors and Importers
In direct comparison with the historically developed regulations, the new law primarily tightens procedural responsibility in digital distribution. The formal obligation to designate a responsible person in the EU for every product and the explicit legal regulation of online marketplaces and fulfilment service providers mark a paradigm shift. The catalogues of fines have been harmonised and drastically increased for systematic infringements of labelling obligations.
Impact on Manufacturers and Consumer Products
Since the final deadline in December 2024, consumers have benefited from a transparent market environment in which counterfeit or unsafe imported goods are identified and withdrawn from the market more quickly. For European manufacturers, the changeover means increased bureaucratic documentation effort in the short term, but in the long term the uniform legal framework throughout the Union protects against unfair competition from cheap imitations from third countries.
Testing and Verification Reference (Our Services)
Chemical-Analytical Testing of Products
As your accredited partner for chemical analyses, we support you wherever critical constituents, problematic operating materials or other chemical risks arise or are to be expected from materials. With the data we generate, you are able to assess risks arising from exposure to hazardous substances and take appropriate mitigation measures.
Support with Risk Analyses, Risk Assessments and Documentation
We accompany you throughout the process of preparing a risk analysis that complies with standards and the subsequent software-supported risk assessment. Our team of experts structures your technical documentation so that it fully meets the demanding requirements of the General Product Safety Regulation. This minimises your personal liability risks as managing director and ensures absolute legal certainty during any unannounced official inspection.
Review of Labelling, Warnings and Information Obligations
We subject your product labels, the graphic design of the packaging and the linguistic correctness of all warnings to a detailed conformity check. From the legally compliant placement of the address and the correct type designation to the integration of manufacturer brands, we ensure that your physical goods and your digital B2B product offers are designed to be fully legally compliant and protected against warning letters.
