Regulation (EU) 2023/988 on general product safety, known as the GPSR, sets the European framework to ensure that consumer products placed or made available on the Union market are safe.
Since 13 December 2024, the GPSR has replaced Directive 2001/95/EC. In Italy, the national framework for coordination and penalties has been updated by Italian Legislative Decree 8 April 2026, No. 78, in force since 16 May 2026.
Regulation (EU) 2023/988: the essentials
The GPSR regulates the general safety of consumer products on the Union market. It applies to products placed or made available on the market, including products sold online or through other distance sales channels, where there are no specific Union provisions covering the same safety risk.
The purpose of the regulation is to ensure a high level of consumer protection by requiring economic operators to adopt a preventive approach: the product must be assessed before sale, documented, traceable and monitored after it has been placed on the market.
Core GPSR principles
Correct application of the GPSR starts from its operational principles. Compliance is not limited to a correct label or an archived test report: product safety must be managed throughout the full product life cycle.
- Every product must be safe: any product intended for consumers in the EU market, or reasonably foreseeable for consumer use, must be safe under the general safety requirement of Regulation (EU) 2023/988.
- Safety covers every aspect of the product: the assessment must consider characteristics, composition, packaging, instructions, warnings, exposed consumer categories and reasonably foreseeable use.
- All economic operators have obligations: manufacturers, importers, distributors, authorised representatives, fulfilment service providers and online marketplaces must comply with the GPSR obligations according to their role.
Internal product safety processes
Economic operators must have internal product safety processes that allow them to comply with the relevant GPSR requirements, under Article 14 of Regulation (EU) 2023/988.
How to ensure product safety
The GPSR requires a continuous and documented process. The absence of complaints or a supplier declaration is not enough: the company must be able to show that the product was assessed, documented and managed consistently with foreseeable risks.
- Design: the stage where product characteristics, materials, intended use and foreseeable conditions of use are defined.
- Risk analysis: the manufacturer identifies hazards, assesses foreseeable risks and defines measures to eliminate or reduce them.
- Technical documentation: the safety rationale must be formalised in verifiable documents available to the authorities.
- Labelling: product and operator information must allow identification, traceability and correct use.
- Instructions and warnings: consumers must receive clear information consistent with residual risks and understandable in the required language.
- Traceability: the product, batch, manufacturer, importer and responsible operator must be traceable along the supply chain.
- Post-market monitoring: complaints, reports, incidents and market information must be collected and assessed systematically.
- Recalls and corrective actions: where a risk emerges, the operator must take proportionate measures, including withdrawal, recall, consumer information and notification to the authorities.
A sound GPSR risk analysis is the foundation of every product safety pathway. The documentation must reflect the product actually placed on the market, not an abstract or generic model.
GPSR penalties in Italy and Legislative Decree 78/2026
Regulation (EU) 2023/988 applies from 13 December 2024, but the Italian national framework for coordination and penalties is now defined by Italian Legislative Decree 8 April 2026, No. 78, published in the Italian Official Gazette No. 111 of 15 May 2026 and in force since 16 May 2026.
The decree replaces Article 112 of the Italian Consumer Code. For placing or making dangerous products available on the market, the new Article 112(1) provides for arrest from six months to one year and a fine from EUR 10,000 to EUR 100,000, increased up to EUR 150,000 where the product presents a serious risk.
The other penalty blocks concern failure to provide information or cooperate with the authority, breach of economic operator obligations and failure to comply with market surveillance authority measures. The detailed analysis is available in the dedicated page on GPSR penalties in Italy.
Economic operators and supply chain responsibilities
The GPSR distributes obligations across the whole supply chain. Responsibility does not concern only the party manufacturing the product: every operator must verify, document or cooperate according to the role actually performed.
Manufacturer
The manufacturer is primarily responsible for product safety and technical documentation.
- performs the internal risk analysis;
- draws up and keeps the technical documentation;
- ensures traceability, instructions and corrective actions.
Importer
The importer is the first operator placing a third-country product on the EU market.
- verifies that the manufacturer has fulfilled the GPSR obligations;
- adds or makes available its own contact details;
- does not place products on the market where there is reason to believe they are dangerous.
Distributor
The distributor must act with due care in relation to the applicable obligations.
- checks visible and documentary elements that can reasonably be verified;
- does not make products available where there is reason to believe they are dangerous;
- cooperates with manufacturers, importers and authorities.
Authorised representative
The authorised representative acts on the basis of a written mandate from the manufacturer and interfaces with the authorities.
- provides documentation upon request;
- cooperates with market surveillance authorities;
- informs the manufacturer about emerging risks.
Fulfilment service provider
This operator may become relevant where no other operator is established in the Union.
- takes part in the supply chain;
- may become relevant for the EU responsible operator framework;
- must cooperate where risks or authority requests arise.
Online marketplace
Online sales channels are central to the GPSR and to the new market surveillance framework.
- must oversee online product information;
- must react to authority requests and measures;
- are also addressed by the new Article 112 of the Italian Consumer Code.
Responsible person in the EU
For the products concerned, an economic operator established in the Union must act as contact point and documentary safeguard towards the authorities. This may be the EU manufacturer, the importer, the authorised representative or, in specific cases, the fulfilment service provider.
Safety Business Gateway, recalls and post-market
GPSR safety does not end with the sale. Operators must monitor market information, handle complaints and incidents, assess emerging risks and activate corrective measures where necessary.
Italian Legislative Decree 78/2026 inserted the new Article 110-bis into the Italian Consumer Code, regulating the Safety Business Gateway and the Consumer Safety Gateway. Economic operators must use the Safety Business Gateway where they consider, or have reason to believe, that a product supplied to the consumer is dangerous.
Operational rule: an effective GPSR procedure should define who collects complaints, who assesses the risk, who decides withdrawal or recall, who notifies through the European portals and who keeps the documentary evidence.
What companies should check
An effective GPSR check should distinguish between substantive product safety, documentary obligations, consumer information and post-market management. A minimum checklist should include:
- product classification, including any applicable harmonised legislation;
- risk analysis and technical documentation;
- identification of manufacturer, importer, distributor and EU responsible person;
- labelling, instructions, warnings and required language;
- procedures for complaints, incidents, recalls, withdrawals and Safety Business Gateway notifications;
- assessment of Italian penalty exposure under Article 112 of the Italian Consumer Code, as replaced by Legislative Decree 78/2026.
Use the GPSR Self-Audit Tool to assess traceability, documentation, e-commerce information, post-market management and penalty exposure.
Every negative answer identifies an issue to check before it emerges during an inspection, dispute or authority request.
Frequently asked questions (FAQ)
Does the GPSR apply to all products imported into the EU market?
Yes, the regulation applies to products intended for consumers or reasonably foreseeable for consumer use, subject to exclusions and to the relationship with specific sector legislation, under Article 2 of Regulation (EU) 2023/988.
Are the technical file and risk analysis mandatory for every product?
The GPSR requires the manufacturer to perform an internal risk analysis and draw up technical documentation under Article 9 of Regulation (EU) 2023/988. The importer must verify that these obligations have been fulfilled under Article 11 of the same regulation.
What is a GPSR risk analysis?
A GPSR risk analysis identifies hazards, assesses foreseeable risks and documents the measures adopted to eliminate or reduce them. This assessment must be part of the technical documentation under Article 9 of Regulation (EU) 2023/988.
If an importer applies its own brand, does it remain only an importer?
No. Where an operator places a product on the market under its own name or trademark, or substantially modifies the product, it may be considered the manufacturer for the applicable obligations under Article 13 of Regulation (EU) 2023/988.
What are the GPSR penalties in Italy?
Italian Legislative Decree 78/2026 replaced Article 112 of the Italian Consumer Code. For dangerous products, Article 112(1) provides for arrest from six months to one year and a fine from EUR 10,000 to EUR 100,000, increased up to EUR 150,000 in case of serious risk. Details are available in the page on GPSR penalties in Italy.
What happens if a product already sold proves dangerous?
The operator must take appropriate corrective measures, inform other operators in the supply chain, cooperate with the authorities and, where necessary, notify the risk through the Safety Business Gateway, under Regulation (EU) 2023/988 and the new Article 110-bis of the Italian Consumer Code, inserted by Legislative Decree 78/2026.
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