Why does the GPSR mandate a review of supply chain contracts?

The entry into force of Regulation (EU) 2023/988 marked a turning point for consumer product safety management. Applicable from December 13, 2024, this regulatory framework repeals the old directive and imposes uniform, stricter rules throughout the EU, eliminating regulatory uncertainty and obligating companies to take a proactive approach.

The most radical change for business is the shift from a trust-based paradigm to one founded on formalized responsibility. The GPSR creates an interconnected chain of obligations that inextricably links every economic operator in the supply chain, from the manufacturer to the distributor.

In this new framework, contracts cease to be simple commercial agreements and become the first line of defense against penalties, costly recalls, and legal disputes between partners. They become the indispensable tool to:

• Precisely define each partner’s tasks.
• Explicitly allocate the burdens of compliance, notification, and intervention.
• Verify that every upstream actor has fulfilled their duties.

The regulation establishes a “general safety net” where shared responsibility is the guiding principle. Relying on verbal agreements or generic clauses is a strategic risk no company can afford to take. To navigate this new reality, it is imperative to understand the specific roles and obligations the GPSR assigns to each economic operator.

New Roles and Key Responsibilities: A Direct Impact on Contracts

The GPSR precisely defines the roles of manufacturer, importer, and distributor, assigning specific obligations of diligence and control to each. Understanding these responsibilities is the first step in structuring contracts that protect the company and ensure the compliance of the entire supply chain.

The Manufacturer: The Guarantor of Safety at the Source

The manufacturer is primarily responsible for the product’s safe design, risk assessment, and the creation of technical documentation (Art. 9). Consequently, the main contractual implication for their partners is the need to obtain ironclad guarantees of the product’s conformity and, above all, to secure the right to access this documentation to respond to authorities. Learn more about the manufacturer’s obligations.

The Importer: The Gatekeeper for EU Market Access

The importer acts as the guarantor of conformity for non-EU products, verifying the manufacturer and placing their own details on the product (Art. 11). Their primary contractual need is to armor-plate their position, making the non-EU manufacturer the sole party financially responsible for any design or production defects. It is therefore vital to contractually transfer the burden of proving conformity to the producer. Learn more about the importer’s obligations.

The Distributor: The Sentinel of the Final Market

The distributor’s role is based on “due diligence,” meaning a formal verification before the sale (Art. 12). Without solid contractual guarantees from their supplier, the distributor risks becoming the only legally challengeable and financially exposed entity in the country in case of problems, even with no fault in the product’s production. Contractually, they must therefore obtain conformity guarantees and define rapid communication channels to report non-conformities. Learn more about the distributor’s obligations.

GPSR Contracts: Strategic Clauses to Integrate into Commercial Agreements

Adapting contracts to the GPSR does not mean drafting legally complex documents, but integrating strategic clauses that protect the company and define clear responsibility management.

• GPSR Compliance Guarantee: legally binds the supplier to comply with the regulation. This clause is the legal basis for rejecting non-compliant batches before they enter your warehouse, avoiding storage and disposal costs for unsaleable goods.
• Access to Technical Documentation and Certifications: guarantees the right to obtain the necessary documents (technical file, risk analysis, certificates, test reports,…) to respond to surveillance authorities, specifying the supplier’s obligation to keep them for 10 years.
• Mutual Information and Notification Obligation: creates a formal and rapid B2B channel to promptly manage incidents, non-conformities, or authority investigations, obligating parties to inform each other without delay.
• Management of Withdrawals and Recalls: defines roles, responsibilities, and cost allocation (logistics, consumer refunds) in case of corrective actions. Without this clause, a recall can trigger a costly legal dispute between partners over who should bear the costs, delaying market action and worsening the damage.
• Supply Chain Traceability: contractually commits the parties to maintain and share batch data to quickly isolate products affected by a safety issue and trace them throughout the supply chain.
• Indemnification and Insurance: Transfers the financial risk (penalties, damages) to the party responsible for the non-conformity, obligating them to hold the business partner harmless from all economic consequences arising from the violation.

Ignoring these clauses is not an option. It means operating in the market without safeguards, exposing yourself to financial and legal consequences that can compromise the business.

Risks and Consequences of Inadequate Contracts

Ignoring the impact of the GPSR on contracts is a strategic risk with tangible consequences. An inadequate contract is not a theoretical problem: it exposes the company to direct costs that can erode margins and, in severe cases, threaten operational continuity. The main risks are:

• Legal and Sanction Risks: surveillance authorities have enhanced powers to impose measures such as seizures, sales bans, and withdrawal orders. Art. 44 of the GPSR imposes penalties that are “effective, proportionate, and dissuasive,” foreshadowing significantly stricter fines than in the past.
• Economic and Operational Risks: the direct costs of a recall are high: logistics, consumer refunds, product disposal, and sales interruption. Added to this are customs blocks for importers and potential civil liability for damages caused by a defective product.
• Reputational Risks: A public recall for safety reasons causes severe brand damage, amplified by the European Safety Gate portal, which makes notifications visible throughout the EU. The subsequent loss of trust from customers and partners can have a lasting and devastating impact on the business.