Recall compliance under GPSR

Global product recalls and corrective action campaigns are high-pressure events involving regulatory scrutiny, legal risk, and public attention. Organizations that prioritize consumer safety, regulatory compliance, mitigating legal exposure, and preservation of brand reputation are often best placed to limit liability and reputational damage.

A product recall aims to swiftly alert consumers of safety risks and enable appropriate corrective action. Its execution is largely shaped by the regulatory requirements of each market where the product is sold. Many jurisdictions impose strict notification obligations, backed by enforcement mechanisms ranging from compulsory recalls and fines to border restrictions, product destruction and criminal liability. Against this backdrop, recall decisions often require rapid judgement calls while facts are still emerging.

Preparing before a safety issue arises

The most effective recall campaigns are planned well before a safety issue arises. Companies should establish a tailored product safety protocol within their broader crisis‑management framework, clearly defining decision-making responsibilities, internal escalation processes and access to key data. Many organizations appoint a dedicated product safety lead or committee, with oversight from senior management and the board.

Preparation also requires a deep understanding of products, supply chain and distribution channels. Businesses must know what their products contain, where components originate and how goods move through distributors and retailers to end users. Robust traceability is critical: regulators increasingly expect companies to identify where affected products are located and to demonstrate that they have taken diligent steps to reach affected consumers. Accurate, accessible recordkeeping – covering product identification, batch or serial numbers, distribution data, incident reports and corrective measures – can significantly reduce friction with regulators during a recall.

Acting quickly when a safety issue emerges

Speed is a defining factor in an effective recall, particularly for food products. Delays can dramatically increase the risk of (physical) harm and regulatory, legal and reputational exposure. Once a potential safety issue arises, companies should investigate promptly, engage relevant expertise, and conduct a structured risk assessment.

Key considerations typically include the nature and root cause of the defect, the likelihood and severity of potential harm, the number and type of consumers affected (including vulnerable groups), potential legal or regulatory breaches, and whether the issue is confined to specific batches or markets. In higher‑risk scenarios, immediate steps may include notifying regulators, isolating products across the supply chain, initiating consumer communications, informing insurers, and escalating the issue internally. External technical experts and legal counsel are often engaged to support defensible decision‑making under regulatory scrutiny.

Communication and recall execution

Clear, effective communication underpins any recall. In many jurisdictions, regulators oversee both the content and method of consumer notifications. While the communication channels depend on the product and its consumer base, companies typically adopt a coordinated, multi-channel approach and may include direct mail or email to registered customers, point‑of‑sale notices, dedicated recall websites, traditional media and, increasingly, social media as a supplementary tool. Equally important is making the recall process as easy as possible for consumers. Online recall portals, free helplines, and prepaid and convenient return, repair and replacement options all help increase participation rates and demonstrate good faith. As recall effectiveness is often measured by response rates, companies should closely monitor progress and adjust their approach as needed.

Coordinating across jurisdictions

For multinational businesses, global coordination is essential. Regulators often share information, and inconsistencies in how a recall is handled across jurisdictions can quickly create compliance risks. While local legal requirements may necessitate jurisdiction‑specific adjustments, a coordinated global strategy is typically more efficient, credible and defensible. Companies should also be mindful of ‘spillover’ effects, as action in one country can trigger notification or recall obligations elsewhere.

Navigating the new legislative landscape under the GPSR

This compliance challenge has become significantly more complex. Since 13 December 2024, the EU General Product Safety Regulation (Regulation (EU) 2023/988; “GPSR”) has replaced the long‑standing General Product Safety Directive, introducing far‑reaching new obligations, particularly in relation to recalls.

The GPSR applies directly across all member states, increasing consistency across the EU. It expands responsibility for product safety beyond manufacturers and importers to include authorized representatives, fulfilment service providers and, in key respects, online marketplaces. Recall requirements have been tightened: identifiable affected consumers must be contacted directly and without delay, notices must follow prescriptive content rules; and effective, timely and cost‑free remedies – such as repair, replacement or refund – must be offered. The GPSR also modernizes EU‑wide coordination through the upgraded ‘Safety Gate’ system, strengthens the European Commission’s powers on traceability and coordinated enforcement actions, and raises the stakes for non‑compliance through national penalty regimes. For companies operating in or into the EU, recall planning is now a core compliance capability.

Final takeaway

For General Counsel, product recall readiness under the GPSR is no longer a reactive exercise, but a core element of risk management and compliance. Ensuring robust governance, defensible decision-making processes, and clear coordination across jurisdictions is critical to limiting regulatory exposure and liability. General Counsel should take a proactive role in stress-testing recall protocols, aligning global and local approaches, and ensuring that the organization is equipped to act decisively under scrutin

Over de auteur(s)

Rutger Doorduyn | Baker McKenzie Amsterdam
Kate Corby | Baker McKenzie London