New Obligations under the EU GPSR – General Product Safety Regulation

In this article we present a summary of requirements for placing a product on the market in compliance with EU regulations – Regulation (EU) 2023/988 (General Product Safety Regulation), abbreviated as: GPSR.

Every manufacturer or economic operator selling products to consumers in the EU (importers, distributors, online sellers) must now comply with the requirements of the GPSR.

This entry focuses on the most extensive obligations of the manufacturer. However, similar obligations apply to other economic operators selling products to consumers within the European Union.

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General Legal Obligations of the Manufacturer

Under the GPSR, the manufacturer bears responsibility for the safety of the manufactured product.

The primary obligations of the manufacturer include:

1. Designing and manufacturing a safe product;
2. Conducting a risk analysis and preparing technical documentation – prior to placing a product on the market, the manufacturer must perform an internal risk assessment and prepare technical documentation confirming the safety of the product;
3. Ensuring traceability and product information – the product and its packaging must bear the required markings, including a product identifier (type/batch number) and manufacturer details (name and contact address), as well as appropriate instructions and information in the consumer's language;
4. Post-market safety monitoring – the manufacturer should implement procedures ensuring that series production maintains conformity with safety requirements;
5. Communication channels – the manufacturer must provide communication channels for receiving complaints, maintain a register of complaints and incidents, and take corrective actions if hazards are detected;
6. Corrective actions for dangerous products – if a product is found to pose a risk, the manufacturer is obliged to immediately withdraw it from the market, notify consumers, and report the fact to supervisory authorities via the Safety Business Gateway.

These obligations translate into specific documents and procedures that the manufacturer must prepare, as discussed below:

I. Risk Analysis and Technical Documentation

The manufacturer is obliged to conduct a detailed product risk analysis and prepare technical documentation before placing the product on the market.

The risk analysis should identify all potential hazards associated with the product (e.g., mechanical, chemical hazards, risks resulting from foreseeable misuse, etc.), assess the probability and consequences of these hazards, and specify the solutions implemented in the design or instructions to eliminate or minimize them.

Technical documentation should contain at least a general description of the product, its design, and essential characteristics relevant to safety. Furthermore, where appropriate, it should include:

• Risk Assessment Report – a description of identified risks and the preventive or protective measures applied (e.g., documenting which material properties or construction features ensure user safety).
• Test Results – if safety tests were conducted (e.g., strength tests, material resistance, absence of harmful substances), the results and reports must be attached.
• List of Applied Standards and Regulations – the manufacturer should identify and list any European, international, or national standards used to meet the general safety requirement under Article 5 of the Regulation.
• Technical Drawings and Material Specifications – although not explicitly listed in Regulation 2023/988, in practice, robust documentation includes photos, construction schemes, and a list of components.

Legal Basis: Art. 9(2) of Regulation 2023/988. This documentation must be kept and updated for 10 years after the product has been placed on the market.

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II. EU Declaration of Conformity (Manufacturer’s Statement)

While the GPSR does not introduce a formal obligation to issue a Declaration of Conformity in the same manner as "New Approach" directives (which require CE marking), it is recommended to prepare a written declaration.

• Purpose: It serves as evidence that the manufacturer has consciously confirmed the product's compliance with safety requirements.
• Note on CE Marking: Products covered only by the GPSR must not bear the CE mark, as CE marking is reserved for products subject to specific harmonization legislation (e.g., Toys, Electronics).

III. Instructions for Use and Safety Information

Every consumer product requiring specific use or assembly must be accompanied by clear instructions and safety information in a language easily understood by consumers in the country of sale.

Instructions should include:

• A step-by-step description of the product's application and use;
• Safety precautions for operating the product;
• Maintenance and conservation information;
• Product and manufacturer identification data.

Legal Basis: Art. 9 (7) of the GPSR. Failure to provide instructions in the local language may be treated as a breach of safety requirements.

IV. Product Marking

To ensure traceability, the manufacturer must mark the product and/or its packaging with:

1. Product Identifier: Type, batch, or serial number (Art. 9(5)).
2. Manufacturer Data: Name, registered trade name or trademark, and contact address (postal and electronic) (Art. 9(6)).

If the product is imported from outside the EU, the importer's details are also required. Markings must be durable and legible.

V. Post-Market Safety Monitoring System

The GPSR emphasizes monitoring products already in circulation. Key elements include:

• Production Quality Control: Procedures ensuring that series production remains consistent with the original safety design (Art. 9(4)).
• Communication Channels: Publicly available contact points (email, phone, web forms) for consumers to report safety concerns.
• Register of Complaints and Incidents: A mandatory internal log of all safety-related complaints and accidents. Data should be kept for no longer than 5 years.
• Informing the Supply Chain: Notifying distributors and sellers if a safety issue is identified.

VI. Corrective Action Procedures: Recall and Incident Reporting

If a product is found to be dangerous, the manufacturer must act immediately:

• Corrective Measures: Stopping further sales, withdrawing the product from the market, or initiating a recall from consumers.
• Safety Business Gateway: Mandatory notification to market surveillance authorities via the centralized EU portal regarding the risks and actions taken.
• Consumer Notification: Using clear, accessible language (as per Art. 35 and 36) to inform users about the danger and necessary steps (e.g., returning the product).

Summary Checklist for Manufacturers

1. Risk Assessment Report & Technical Documentation
2. EU Declaration of Conformity (Recommended Practice)
3. Instructions for Use & Safety Information (in the local language)
4. Product Marking (Traceability & Manufacturer Data)
5. Post-Market Monitoring System (Complaint registers & Quality control)
6. Corrective Action Plan (Recall procedures & Safety Business Gateway readiness)

Authors: Anna Jurkiewicz, Julia Armata.

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How We Can Help

Are you placing or importing a product into the EU market and are unsure how to draft the documentation required under the GPSR? At Armata Legal, we assist our clients in legally bringing products to market. We can:

• Audit existing documentation and procedures for GPSR compliance;
• Draft the required technical and safety documentation;
• Conduct training for employees on GPSR regulations and procedures;
• Provide legal counsel in the event of safety incidents or reported risks;
• Represent manufacturers, distributors, and importers during inspections and in proceedings related to penalties for GPSR violations.

If you need assistance with GPSR implementation, feel free to contact us: Contact.