New EU Product Recall Requirements under the General Product Safety Regulation: What do companies need to know?

What is regulated in the GPSR?

The GPSR lays down essential rules on the safety of consumer products that are placed on the EU market or are made available on the EU market.²  Before the GPSR, rules on product safety in the EU were regulated by the General Product Safety Directive (GPSD).³  The GPSD acted as a safety net for those products whose safety was not regulated in a specific EU legislation. The GPSR continues following the approach of the GPSD that only safe products may be placed or made available on the market.

The GPSR provides multiple factors to be taken into account to assess whether a product is safe, including its design, technical features, composition, interconnection with other products, labelling, appearance, and categories of consumers using the product.⁴  Products are presumed safe if they conform to the relevant EU standards, or, in the absence of any relevant EU standards, conform to the national health and safety requirements of the Member State in which it is made available on the market.⁵

Who needs to comply with the GPSR?

As of 13 December 2024, the GPSR applies directly to new, used, repaired or reconditioned products which are available for distribution, consumption or use in the EU.⁶  In other words, products placed or made available on the EU market after this date must comply with the requirements of the GPSR, even if they are produced outside of the EU. However, the GPSR does not cover all products, as the following products are excluded from its scope:

• Medicinal products for human or veterinary use;

• Food and feed;

• Living plants and animals, genetically modified organisms and microorganisms in contained use;

• Animal-derived and by-products;

• Plant protection products;

• Transport equipment operated by a service provider;

• Aircraft whose design, production, maintenance and operation pose a low safety risk;

• Antiques;

• Products clearly marked to be repaired or reconditioned prior to use.⁷

For products excluded from the GPSR, other specific legislative arrangements apply. This means that before initiating a product recall, companies must first determine the applicable regulatory framework for the product in question. Different regulations impose different requirements, including on timing, reporting obligations, and the authorities that must be notified. Failing to correctly assess the relevant regulatory landscape at the outset may lead to inadvertent non-compliance, even if a company acts in good faith but follows the wrong set of rules.

Expanded scope of the GPSR

Compared to its predecessor, the GPSD, the GPSR applies to a wider range of economic operators. It now covers:

• Manufacturers, distributors, and importers;

• Fulfillment service providers (e.g., warehousing, packaging, addressing, dispatching);

• Online marketplace providers;

• Any entity that significantly modifies a product.

By expanding the scope, the GPSR strengthens accountability across the entire supply chain, including digital and logistical intermediaries.

What is a product recall?

Under the GPSR, when an unsafe product is made available to consumers, companies are required to execute a product recall—meaning they must take measures to retrieve the unsafe product from consumers and prevent further harm.

It is important to differentiate between a product recall and a product withdrawal:

• A product recall applies when the product has already reached consumers. The company must actively seek to remove the product from the market and notify affected consumers.

• A product withdrawal refers to actions taken to prevent an unsafe product from being made available to consumers. This applies when the product has left the company’s facilities but has not yet reached end-users.

The GPSR strengthens recall obligations, introducing stricter requirements on traceability, consumer communication and reporting obligations to ensure a more effective and harmonized approach across the EU.

When should a product be recalled according to the GPSR?

The GPSR is very clear: dangerous products placed on the EU market should be withdrawn or recalled. While the GPSR encourages all economic operators (i.e. a manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations under the GPSR) to make customers aware of product recalls, only manufacturers, importers and distributors are required by the GPSR to actually carry out a product withdrawal or recall.

• If a manufacturer considers or has reasons to believe that it has placed a dangerous product on the EU market, it must immediately withdraw or recall the product.⁸  In that case, the manufacturer must inform consumers and the relevant authorities of the Member State(s) in which the product has been placed on the market.⁹

• If an importer considers or suspects that a dangerous product has been placed on the EU market, the importer must immediately inform the manufacturer and consumers and take corrective measures including a product withdrawal or recall.¹⁰

• Similarly, distributors are also required to inform the manufacture and, where applicable, the importer, of any dangerous products that they have placed on the market and they must also take appropriate corrective action, including the immediate withdrawal or recall of the product.¹¹

Potential challenges and conflicts in the expanded scope

The expanded scope of the GPSR creates new compliance obligations but may also lead to tensions between different stakeholders in the supply chain. For example, distributors may adopt a more risk-averse approach, choosing to suspend sales or remove a product from the market based on customer complaints or safety concerns—even in cases where the manufacturer does not believe sufficient evidence exists to classify the product as unsafe.

A distributor or online marketplace provider may decide to stop selling a product based on a single consumer complaint or a safety alert from a third party, while the manufacturer—who has more detailed product knowledge—may resist a recall unless concrete proof of risk is established. Similarly, an importer might take a precautionary approach to avoid liability, creating friction with manufacturers that prioritize business continuity.

These conflicts can disrupt supply chains, create reputational risks, and lead to regulatory scrutiny. To manage these tensions, companies should establish clear internal processes, risk assessment protocols, and communication channels between all parties subject to the GPSR to ensure timely and coordinated decision-making.

What are the GPSR’s requirements for product recalls?

The GPSR provides some detailed rules on product recalls. These new rules aim to ensure a more complete and widespread provision of information for consumers as well as an enhanced system of remedies available to consumers that have purchased products that are subsequently recalled.

1. Direct contact with consumers. The GPSR requires economic operators to notify affected consumers of a product recall without undue delay. Direct contact with customers - using customer data - is considered most effective. However, when that is not possible, economic operators must contact customers through a safety warning or recall notice through appropriate channels such as social media.¹²
2. Recall notice. The EU concludes that one-third of consumers continue to use dangerous products despite seeing a recall notice, particularly because recall notices are complex or down play the risk at stake.¹³  Consequently, the GPSR lists the exact details to be included in a recall notice to ensure notices are easily understandable.¹⁴  Moreover, the GPSR states that recall notices should be issued in the language(s) of the Member State(s) where the product has been made available.¹⁵  The EU has provided a template companies can use, please see: link.
3. Remedies. Economic operators must offer consumers effective, cost-free and timely remedies when a product is recalled.¹⁶  In that regard, economic operators must offer consumers, at least, the choice between two of the following options: repair (in case the safety of the repaired product can be ensured), replacement or adequate refund, except where the choice between two options would be impossible or disproportionate.¹⁷
4. Safety Gate. The EU rapid alert system for dangerous non-food products – previously called the Community Rapid Information System – will continue to exist under the GPSR but has been renamed to Safety Gate. Member States are required to notify dangerous products through Safety Gate when those dangerous products have been placed on the EU market.¹⁸  Companies are required to inform authorities and consumers of dangerous products and accidents through Safety Gate (via the Safety Business Gateway).¹⁹
5. Register. The GPSR requires manufacturers and importers to keep an internal register of, among others, product recalls.²⁰

Best practices: What should companies do in the initial stages of a product recall?

Effectively managing a product recall is a high-stakes challenge that requires swift decision-making, cross-functional coordination and strict regulatory compliance. A poorly handled recall can have far-reaching consequences, including:

• Reputational damage: Loss of consumer trust, negative media coverage and long-term brand erosion.

• Regulatory penalties and fines: Failure to comply with GPSR requirements or national enforcement actions may result in significant financial and legal repercussions.

• Health and safety risks: Delays or inadequate recall efforts can expose consumers to harm, leading to lawsuits and further regulatory scrutiny.

• Operational and supply chain disruptions: Product recalls can cause logistical challenges, stock shortages and strained relationships with suppliers, distributors and retailers.

• Financial loss and shareholder impact: Recalls can lead to sharp drops in share value, lost revenue and costly remediation efforts.

Successfully navigating a recall requires a structured, well-prepared response plan that aligns with regulatory obligations, minimizes business disruption and prioritizes consumer safety. Taking swift and well-coordinated actions in the initial stages of a product recall is critical to ensuring regulatory compliance, consumer safety and minimizing business disruption. Before defining the recall strategy and initiating operational recall activities (i.e., product collection and removal from the market), companies should take the following key steps:

1. Establish a detailed log of events

• Maintain a comprehensive, time-stamped record of all key actions and decisions.
• A well-documented log is crucial for regulatory inquiries, legal proceedings and internal reviews.
• Under the GPSR, manufacturers and importers must record recalls in an internal log to demonstrate compliance.

2. Gather comprehensive factual information

To determine the scope and impact of a recall, companies should request critical data from relevant departments. Below is an example of an information request list that could be used as a starting point:

3. Engage key advisors and experts

• Involve legal counsel early to secure attorney-client privilege and ensure compliance with recall obligations.
• Retain forensic experts to investigate product defects and safety risks.
• Consult with crisis communication specialists to prepare for potential media or public scrutiny.

4. Conduct a risk assessment

Assess the severity, urgency and exposure of the recall based on the collected data:

• Health and safety risk: Evaluate consumer harm potential and whether immediate action is required.
• Regulatory exposure: Identify non-compliance risks and necessary corrective actions.
• Reputational and financial risk: Estimate brand damage, business disruption and potential legal claims.
• Operational impact: Consider whether to pause production or distribution to prevent further risk.

5. Perform a legal and regulatory compliance assessment

• Determine which regulatory framework applies, as different product categories are governed by different laws.
• Identify mandatory reporting obligations, such as:
  • GPSR-regulated products → Report recalls to Safety Gate.
  • Food and feed recalls → Report to national food safety authorities (e.g., Nederlanse Voedsel en Waren Authoriteit (NVWA) in the Netherlands) within sometimes strict timeframes (e.g., unsafe products must be reported within four hours to the NVWA).
• Consider EU cross-border notification requirements if products have been distributed in multiple Member States.

6. Conduct a commercial and insurance assessment

• Evaluate contractual obligations to distributors, suppliers and retailers regarding recall notifications and compensation.
• Notify insurers promptly, as coverage for product recalls and withdrawals often depends on strict reporting timelines.
• Review existing insurance policies in light of the GPSR’s expanded scope, ensuring sufficient coverage for new obligations and liabilities.

7. Develop a recall action plan

Once factual, legal and risk assessments are complete, define a clear recall strategy that includes:

• Communication plan: Draft regulatory notifications, customer advisories and press releases.

• Product retrieval and disposal strategy: Establish safe collection, quarantine and disposal procedures.

• Stakeholder coordination: Assign clear roles to internal teams and engage external partners as needed.

By following these structured steps as a minimum, companies can navigate recalls efficiently, protect consumers and mitigate business risks while ensuring compliance with the evolving regulatory landscape under the GPSR.

This content is provided for general informational purposes only and does not constitute legal or professional advice. Every product recall presents unique challenges and requires a tailored approach based on the specific circumstances, regulatory requirements, and risks involved. Companies should seek guidance from experienced professionals to ensure an effective recall strategy and compliance with applicable laws.