Reminder on GPSR (Global Product Safety): your obligations as Manufacturer, Importer & Distributor.

The new Global Product Safety Regulation is live since December 2024.

The new EU General Product Safety Regulation (GPSR) is enforced since 13 December 2024, replacing the long-standing General Product Safety Directive. This is not a minor update; it's a significant modernization of the EU's product safety framework, designed to address the challenges of online sales, new technologies, and complex global supply chains. For all economic operators - manufacturers, importers, and distributors - who place consumer products on the EU market, understanding these new rules is not just advisable, it's essential for continued business.

This article breaks down the most critical changes introduced by the GPSR. It provides a clear, scannable guide to help you understand your obligations, verify compliance across your supply chain, and make sure you comply with the new era of product safety.

In essence, the GPSR acts as a new safety net, applying to the vast majority of non-food consumer products sold in the EU, whether new, used, repaired, or reconditioned. It is a "horizontal" piece of legislation, meaning it fills the gaps where no specific, sector-based EU safety laws exist. Think of products like furniture, textiles, childcare articles, sports equipment, bicycles, and DIY tools for consumers. Where products are already subject to specific EU legislation (such as toys, electronics, or cosmetics), the GPSR will still apply to any risks not covered by those sector-specific rules, such as the cybersecurity of a connected device. The regulation does not apply to a few specific categories, including medicinal products, food and feed, and antiques.

1.Master the Foundation: The General Safety Obligation

This is a fundamental shift, requiring you to proactively assess safety not just for a product's intended use, but for its entire lifecycle, especially in a connected world.

The core principle of the GPSR is the General Safety Obligation. Article 5 states this plainly: all economic operators must only place or make available safe products on the market.

According to Article 3, a "safe product" is one that presents no risk, or only minimal risks compatible with its use, while ensuring a high level of protection for the health and safety of consumers.

To determine if a product is safe, Article 6 expands the assessment criteria to include a comprehensive set of modern factors. Economic operators must now consider:

• The product's characteristics, including its design, technical features, composition, packaging, and instructions for assembly, installation, use, and maintenance.

• Its effect on other products, especially where it is reasonably foreseeable that it will be used with them.

• The product's presentation, labeling, any warnings, instructions for safe use and disposal, and other product information.

• The specific consumer categories at risk when using the product, particularly vulnerable groups like children, the elderly, and persons with disabilities.

• The product's appearance, especially where a non-food product resembles a foodstuff due to its form, smell, color, or packaging, and could be mistaken for one and ingested, particularly by children.

• Crucially, the GPSR introduces new technological risks: Cybersecurity features necessary to protect the product from external influences, including malicious third parties, that could impact its safety.

• The functions of products that are evolving, learning, and predictive, and how these changing functionalities might affect safety over the product's lifetime.

  
  

To streamline compliance, Article 7 establishes a Presumption of Conformity. A product is presumed to be safe if it conforms to relevant European standards whose references have been published in the Official Journal of the European Union.

2.Know Your Role, Know Your Duties

The GPSR leaves no room for ambiguity, assigning clear, non-delegable duties to each actor in the supply chain - making it critical to understand your specific legal responsibilities.

The GPSR assigns specific, distinct responsibilities to each economic operator in the supply chain. It is critical to understand which role you play and the duties that come with it.

For Manufacturers (Article 9)

• Conduct an internal risk analysis and create detailed technical documentation before placing a product on the market. This documentation must be kept and made available to authorities for 10 years.

• Ensure products are marked with a type, batch, serial number, or other element to allow for clear identification.

• Clearly indicate their name, registered trade name or trademark, and contact details (postal and email address) on the product or, if not possible, on its packaging or in an accompanying document.

• Provide clear instructions and safety information in a language easily understood by consumers in the EU Member State where the product is sold.

• If they believe a product is dangerous, they must immediately take corrective measures (such as withdrawal from the supply chain or a recall from consumers) and inform the relevant authorities via the Safety Business Gateway.

• Establish publicly available channels, such as a phone number, email address, or a specific section of their website, allowing consumers to submit complaints and report accidents or safety issues they have experienced with a product.

  
  

For Importers (Article 11)

• Before placing a product on the EU market, importers must verify that the manufacturer has fulfilled its obligations, including preparing the technical documentation and affixing traceability and contact information.

• They must not place a product on the market if they believe it is non-compliant or dangerous.

• They must indicate their own name, trade name or trademark, and contact details on the product, its packaging, or an accompanying document.

• They must ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available on the market.

• If a product they have placed on the market is found to be dangerous, they must take immediate corrective actions and inform the authorities.

  
  

For Distributors (Article 12)

• Before making a product available, distributors must act with due care by verifying that the product meets the obvious compliance requirements, such as the presence of the manufacturer's and importer's information and traceability markings.

• They must not make a product available if they believe it is non-compliant with safety requirements.

• If they believe a product they have supplied is dangerous, they must immediately inform the manufacturer or importer and the market surveillance authorities.

  
  

A Note on "Substantial Modification" (Article 13)

Any economic operator who substantially modifies a product in a way that affects its safety is considered the manufacturer. This also applies to an operator who markets a product under their own name or brand. For example, if a company takes a non-connected children's toy, adds software to it that connects it to the internet, and re-sells it, they have likely made a 'substantial modification' and are now considered the manufacturer. This is a critical point for businesses that repair, refurbish, or upgrade products, as these activities could inadvertently shift the full weight of a manufacturer's legal obligations onto them.

Prove Compliance: Technical Documentation & Traceability Are Non-Negotiable

Under the GPSR, compliance is not a matter of trust but of verifiable proof, making your technical documentation and traceability systems the bedrock of your market access.

Under the GPSR, claiming a product is safe is not enough; you must be able to prove it. The technical documentation required by Article 9 is the central pillar of this proof, serving as the tangible evidence that you have fulfilled the General Safety Obligation outlined in Section 1. It must be based on an internal risk analysis and, at a minimum, contain a general description of the product and an analysis of the potential risks and the solutions adopted to mitigate them.

A tool like Qleer.ai can help you automatize product conformity assessment an prove compliance in an easy and safe way.

Traceability is equally critical. Articles 9 and 11 mandate that clear information must be physically present on the product (or its packaging or an accompanying document). This includes information that identifies the product itself (type, batch, or serial number) and the relevant economic operators (the manufacturer and, if applicable, the importer, including their names and contact details).

Looking ahead, Article 18 gives the European Commission the power to implement even stricter traceability systems for certain products or product categories that may pose a serious risk to consumer health and safety.

The E-Commerce Revolution: New Rules for Online Sales

The GPSR effectively eliminates the regulatory grey area for e-commerce, making online platforms and non-EU sellers directly accountable for the safety of products sold to EU consumers.

A major focus of the GPSR is to close the product safety gap between products sold online and those sold in brick-and-mortar stores. The new rules introduce significant obligations for distance and online selling.

Under Article 19, any online product offer targeting EU consumers must now clearly and visibly display:

• The manufacturer's name and contact details (postal and email address).

• If the manufacturer is based outside the EU, the name and contact details of the EU-based Responsible Person.

• Information to clearly identify the product, including a picture, its type, and any other product identifiers.

• Any necessary safety warnings or information, in a language easily understood by consumers.

• Critically, Article 16 mandates that a product sold from outside the EU can only be placed on the Union market if there is an economic operator established in the Union designated as the Responsible Person for it. This operator acts as the point of contact for authorities and is responsible for verifying key compliance documents. This closes a long-standing loophole where non-EU sellers could ship directly to consumers without a legal entity in the Union that authorities could hold accountable for unsafe products.

Responding to Incidents: Mandatory Accident Reporting and Modernized Recalls

The regulation overhauls post-market surveillance, shifting from a reactive approach to a proactive system of mandatory reporting and consumer-centric recalls.

The GPSR strengthens post-market surveillance obligations, creating new duties for reporting accidents and making product recalls more effective and consumer-friendly.

A new mandatory accident reporting obligation is introduced in Article 20. Manufacturers must, without undue delay, report accidents caused by their products that have resulted in a person's death or serious adverse effects on their health. This report must be submitted to the authorities of the Member State where the accident occurred via the Safety Business Gateway. Importers and distributors who become aware of such an accident must promptly inform the manufacturer.

The rules for product recalls have been significantly modernized under Article 37. When a product is recalled, the responsible economic operator must offer consumers an effective, free, and timely remedy.

Consumers must be offered a choice between at least two of the following options: Repair of the recalled product.

Replacement with a safe product of at least the same value and quality.

An adequate refund of the product's value, which should be at least the price the consumer paid.

The GPSR's recall framework is built on two pillars: proactive communication using customer data (Article 35) and providing compelling, no-cost remedies to incentivize consumer action (Article 37).

Operators must use any customer data they possess (such as from loyalty programs or product registrations) to directly inform consumers about recalls and safety warnings, ensuring that crucial safety information reaches those who need it most.

Conclusion: Are You Compliant with GPSR?

The General Product Safety Regulation represents a major step forward in consumer protection within the EU. It demands that businesses to be more proactive, transparent, and accountable for the safety of the products they place on the market. Vague compliance is no longer an option; the GPSR requires clear evidence, robust processes, and swift action when issues arise.

In case of doubt, it urgent to review your supply chains, update your compliance procedures, and ensure you have the systems in place to meet these heightened standards.