The Regulation (EU) 2023/988 on general product safety (GPSR) sets essential rules to ensure that every product sold on the European Union market is safe.
Since 13 December 2024, this Regulation has replaced the previous Directive, introducing specific obligations for all economic operators along the supply chain, from manufacturer to distributor. The primary goal is to raise the level of consumer health protection.
EU Regulation 2023/988: what you need to know
Since 13 December 2024, the European Union market has been governed by Regulation (EU) 2023/988 on general product safety, known as the GPSR (General Product Safety Regulation).
This legislation replaces Directive 2001/95/EC, introducing a more stringent and modern framework. The main objective of the GPSR is to ensure a high level of consumer protection by setting clear principles and obligations for all operators. Understanding the fundamentals of this Regulation is the first step to ensuring your products’ compliance.
Key principles of the GPSR
To approach the new regulatory framework strategically, it is essential to understand the pillars on which the GPSR is based. These principles define the spirit of the law and guide the interpretation of obligations for each economic operator. Keeping these core concepts in mind allows you to organise internal processes proactively and in compliance.
Every product must be safe: any product intended for EU consumers—or reasonably foreseeable to be used by them—must be safe.
Safety covers all product aspects and all risks: the safety assessment must cover every component, including information, instructions and warnings. It extends to all potential risks to health (physical, mental, environmental), with particular focus on vulnerable users (children, older people, persons with disabilities).
All economic operators are subject to obligations: no operator is exempt. Regardless of size and turnover, every actor in the chain has specific responsibilities according to their role and may be sanctioned in case of non-compliance.
These principles make it clear that safety is not optional but a fundamental requirement that every economic operator must ensure through a structured process.
This is explicitly required by Article 14 of the Regulation:
Internal processes for product safety
Economic operators shall ensure that they have internal processes for product safety in place, allowing them to comply with the relevant requirements of this Regulation.
How is a product’s safety ensured?
The GPSR requires a continuous, documented process that goes far beyond a simple supplier self-declaration or the absence of complaints. It is an ecosystem of interlinked activities that accompany the product throughout its life cycle.
The key elements of this process include:
Design: the initial stage where the foundations are laid to achieve the high level of safety required by the Regulation.
Risk analysis: a core activity whereby the manufacturer must identify, assess and mitigate the product’s inherent risks. A sound risk analysis within the context of the Regulation is the basis of any compliance pathway.
Technical documentation: the approach adopted to ensure safety must be formalised in a technical file, demonstrable and available to the authorities.
Labelling: complete and correct information on the product and packaging ensures traceability, protecting both consumers and economic operators.
Instructions and safety information: users must receive clear, complete and understandable instructions for safe use of the product.
Compliance management systems: economic operators are required to implement internal processes to manage and constantly monitor product safety.
EU Responsible Person: each product must have an economic operator established in the EU designated as a point of contact and guarantor for the market surveillance authorities.
Post-market: safety management continues after sale through the collection and analysis of market information to trigger any corrective actions.
An accurate risk analysis is the foundation of every safety journey under the GPSR. Further details on methods, tools and responsibilities are available in the section dedicated to the risk analysis in the context of the General Product Safety Regulation.
A shared responsibility along the supply chain
The GPSR adopts a holistic approach to consumer safety, recognising that it is not exclusively the manufacturer’s task. The Regulation assigns specific and proportionate obligations to each economic operator involved in placing and making products available on the EU market.
Failure to comply with these obligations exposes all companies, regardless of size, to effective, proportionate and dissuasive penalties.
A clear allocation of duties across the entire chain aims to ensure that only safe products reach European consumers, creating a stronger and more effective network of control and responsibility.
Manufacturer
Any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under their name or trademark.
- Ensure safety “by design”: Perform an internal risk analysis before placing on the market.
- Draw up and keep technical documentation: Must be kept for 10 years and provided to authorities upon request.
- Affix traceability information: Include product identifier, own name, and contact details.
Importer
Any natural or legal person established within the Union who places a product from a third country on the Union market.
- Verify manufacturer compliance: Ensure the manufacturer has carried out the risk analysis and drawn up the technical documentation.
- Add own contact details: The importer’s name and address must be clearly visible on the product.
- Do not place non-compliant products: In case of doubt regarding safety, inform the manufacturer and the authorities.
Distributor
Any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.
- Act with due care: Verify the presence of mandatory information on the product before making it available.
- Inform other operators of risks: Immediately signal any safety issue to the manufacturer or importer.
Authorised Representative
Any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on their behalf.
- Act as liaison with authorities: Provide product safety documentation and cooperate upon request.
- Inform the manufacturer about risks: Immediately signal any suspicion that a product may be dangerous.
Fulfilment Service Provider
Any natural or legal person offering services such as warehousing, packaging, addressing or dispatching.
- Can automatically become the Responsible Person: Assumes this role if there are no other operators (manufacturer, importer) established in the EU.
The Responsible Person in the EU
Who is the Responsible Person?
It is mandatory for every product. It can be the manufacturer (if EU), the importer, the authorised representative, or a fulfilment service provider.
- Be the official contact point in the EU: Their name and contact details must be indicated clearly on the product or its packaging.
- Verify product compliance: Ensure that technical documentation has been drawn up and is available to authorities.
- Cooperate and act in case of risks: Inform authorities, cooperate with requests, and ensure corrective measures are taken.
Use the Self-Audit Tool (15 critical points) to instantly assess your company’s command of traceability, e-commerce compliance, and post-market management. Every ‘NO’ represents a sanctionable vulnerability you must identify now.
Includes the option for a 30-minute technical assessment session to analyze identified vulnerabilities and define intervention priorities.