EU General Product Safety Regulation (GPSR)

The EU General Product Safety Regulation (GPSR – EU 2023/988) has been fully applicable since December 2024, replacing the General Product Safety Directive of 2001. It applies to all consumer products placed on the EU market for which no more specific product safety legislation exists. The GPSR tightens reporting obligations, strengthens market surveillance, and introduces explicit requirements for digital products and online marketplaces.

For manufacturers of consumer goods, electronics, household appliances, and other consumer products, the GPSR is immediately relevant—with concrete impacts on traceability, documentation, and internal processes.

Key Changes from the Previous Directive

Unlike the 2001 Directive, which left significant room for national implementation, the GPSR is a Regulation. It applies directly and uniformly across all EU member states without the need for national implementation acts.

The Most Important Innovations:

• Expanded Traceability: Products must be labeled so they can be traced back to the manufacturer and the specific production batch.
• Stricter Reporting Obligations: If a manufacturer becomes aware that a product poses a safety risk, they must notify market surveillance authorities immediately.
• Direct Consumer Notification: Manufacturers must personally inform affected consumers about safety risks, provided contact details are available.
• Safety Business Gateway: The EU has established a central portal where product recalls and safety warnings are reported and published.
• Mandatory Internal Risk Assessment: Before placing a product on the market, manufacturers must systematically and documented assess potential safety risks.

Who is Specifically Affected by the GPSR?

The GPSR applies to manufacturers, importers, distributors, and fulfillment service providers of consumer products. While it does not apply to products used exclusively for B2B purposes, products that can be used by both businesses and consumers (dual-use) fall under the regulation.

Traceability: Requirements for Production and Sales

The GPSR introduces explicit requirements for product-related traceability that go beyond general labeling duties.

Identification and Tracking

Products must carry a unique product identification: type designation, batch number, or serial number, along with the name and contact address of the manufacturer. This information must be on the product itself or its packaging and remain legible.

The Role of MES in Traceability

The decisive operational requirement is the ability to isolate batches quickly. If a safety issue is identified, manufacturers must be able to determine which batches are affected and where they are located—whether in the warehouse, with the retailer, or with the end consumer.

This requirement is virtually impossible to fulfill without systematic batch tracking in production. An MES (Manufacturing Execution System) that tracks batches from the manufacturing process to shipping provides the production-side foundation, while linking this to CRM or ERP sales data completes the chain to the end customer.

Reporting Obligations: Timelines and Communication

The GPSR defines clear reporting duties as soon as a manufacturer gains knowledge of a product safety risk.

Immediate Notification via Safety Gate

Manufacturers must inform the competent market surveillance authorities of all affected EU member states via the EU Safety Business Gateway.

Recall Communication

Recall notices must be clear and understandable. A significant change is the requirement for direct consumer contact. If product registrations, warranty sign-ups, or purchase data exist, manufacturers must contact consumers directly rather than relying solely on public announcements.

Internal Documentation and Liability

Manufacturers must maintain technical documentation for ten years after the last unit of a product model has been placed on the market. This includes:

1. Risk assessments conducted before market launch.
2. Test reports and proofs of conformity.
3. Complaints and reported accidents.
4. Corrective actions taken for safety issues.

Connection to Product Liability

The GPSR and product liability law are closely linked. Violating GPSR duties—such as failing to report a known risk—significantly worsens a company's liability position in the event of damage, as courts often interpret this as a lack of due diligence.

FAQ

Does the GPSR apply to products launched before December 2024?

The GPSR applies to products placed on the market from the application date in December 2024. However, the reporting obligations apply to all products currently in the market as soon as a safety risk becomes known, regardless of the manufacturing date.

What is the difference between GPSR and CE Marking?

The CE mark confirms that a product meets specific EU directives (e.g., Machinery, Low Voltage, or EMC). The GPSR acts as a safety net that applies when no specific legislation exists. If a product falls under specific CE legislation that covers safety risks, that specific law takes precedence.

How does the GPSR differ from the new EU Product Liability Directive?

The GPSR is preventative safety law, prescribing how to bring safe products to market. The new EU Product Liability Directive is reactive liability law, regulating the civil consequences if damage occurs. GPSR compliance improves your legal position; violations worsen it.

How is the GPSR enforced?

In the EU, market surveillance is coordinated via the RAPEX/Safety Gate system, which shares info on unsafe products between member states. In Germany, market surveillance is handled by state authorities, coordinated by the Federal Office of Consumer Protection and Food Safety (BVL) and the Federal Network Agency (BNetzA).