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Complete guide to the General Product Safety Regulation (GPSR)

The General Product Safety Regulation (GPSR) is a crucial piece of legislation designed to ensure that products sold within the European Union (EU) are safe for consumers. With the growth of global trade and the diversification of product lines, it is essential that businesses, manufacturers, and importers stay informed about GPSR requirements. This guide offers an in-depth look at the GPSR, detailing its core obligations, the stakeholders it impacts, and practical steps businesses can take to maintain compliance, safeguard consumers, and uphold their brand reputation.

What is the General Product Safety Regulation (GPSR)?

The General Product Safety Regulation (GPSR) is an EU-wide regulation that mandates the safety of consumer products. However, it is not limited to consumer goods alone; it also applies to professional products likely to be used by consumers. Both CE-marked and non-CE-marked products can fall under this regulation, meaning that the scope of the regulation is large..

The GPSR’s primary aim is to guarantee the safety of goods sold both offline and online through any sales channel. It replaces previous national regulations, establishing a unified standard for product safety across all EU member states. The regulation’s main objective is to ensure that only safe products are placed on the market, thereby reducing the risk of harm to consumers. It applies to a wide range of products, including electronics, toys, household goods, and cosmetics.

Who does GPSR apply to?

The GPSR applies to various parties involved in the supply chain, each with distinct responsibilities to ensure product safety:

  • Manufacturers: It is their duty to ensure that products adhere to safety regulations prior to being marketed. This obligation includes carrying out risk evaluations and retaining relevant technical documentation.
  • Importers: They must ensure that products brought into the EU from external markets align with the GPSR, verifying that manufacturers have adhered to all necessary safety requirements.
  • Distributors: Their role is to ensure that the products they supply are safe and traceable and that appropriate documentation is available.
  • Authorised representatives: Appointed by non-EU manufacturers, authorised representatives carry out specific tasks on behalf of the manufacturer. While the ultimate responsibility for product compliance remains with the manufacturer, the authorised representative has obligations such as maintaining technical documentation, cooperating with authorities, and ensuring corrective actions are taken.
  • Fulfilment service providers: These entities, handling tasks like storage, packaging, and shipping on behalf of manufacturers or sellers, may also, under certain circumstances, be responsible under the GPSR for ensuring product compliance with safety regulations.

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    Each of these parties has distinct obligations under the GPSR, making it essential for businesses to understand and fulfil their specific responsibilities to maintain compliance.
    explanation how to determine who the economic operator is

The economic operator across different supply chain frameworks

 

What is the relation between GPSR and CE Marking?

The General Product Safety Regulation (GPSR) and CE marking are closely related within the European regulatory framework, but they serve distinct purposes in ensuring product safety and compliance.

CE marking is a certification that indicates a product meets the essential health, safety, and environmental requirements defined by European Union directives. The CE mark is mandatory for a wide range of products sold within the European Economic Area (EEA) and signifies that the product complies with all applicable CE requirements. For many products, CE marking is not solely about safety; it also encompasses other aspects such as electromagnetic compatibility and energy efficiency.

visualisation of 6 step process to get the ce marking

The six steps of the CE marking process

The GPSR complements CE marking by providing a general safety framework that applies to all consumer products not covered by specific sectoral legislation requiring CE marking.

“Essentially, the GPSR serves as a catch-all regulation. If there are risks with a consumer product not covered by other legislation, the GPSR applies and mandates that these products must be safe, with risks mitigated.”
– Roberth Jonsson, CEO 24hour AR –

For products requiring CE marking, compliance with the GPSR is implicitly required. The CE marking process involves assessing a product’s conformity with relevant safety standards, which inherently includes meeting the general safety requirements outlined by the GPSR. Therefore, if a product bears the CE mark, it should also comply with the safety standards mandated by the GPSR.

One illustrative example of how the General Product Safety Regulation (GPSR) complements specific CE directives can be observed in the context of the EMC directive (2014/30/EU). While the EMC directive is a CE marking directive, it does not cover the safety of a product. This means for instance that a product that may only fall under EMC directive (and possibly RoHS directive), e.g. a large wall hung watch, does not have any safety requirements laid on it. A large wall hung watch may topple over or fall down potentially causing harm to people or property, meaning that this risk needs to be addressed.

This is where the GPSR plays a crucial role. By stepping in to address these risks, the GPSR ensures a more comprehensive approach to product safety. It requires manufacturers to consider and mitigate all potential hazards associated with their products, including those not covered by the EMC directive. In our example of the wall hung watch, the GPSR mandates that any of these risks must be identified and managed. This might involve conducting additional testing, ensuring fastening techniques, or providing clear warnings and instructions to users.

By filling these gaps, the GPSR ensures that all potential risks are considered, thus guaranteeing that the electric wall hung watch not only meets the specific requirements of the EMC directive but is also safe in a broader sense. This holistic approach to product safety helps to protect consumers from a wider range of hazards, ensuring that personal protective equipment is truly safe for use in any context.

protective gloves in use in inspection of product

Protective gloves are covered by the PPE directive but should also comply with the GPSR

 

Main differences between the General Product Safety Directive (GPSD) and the General Product Safety Regulation (GPSR)

The General Product Safety Directive (GPSD) and the General Product Safety Regulation (GPSR) are both critical for ensuring consumer product safety within the European Union. Although similar in purpose, they differ in their legal structure, scope, enforcement mechanisms, and approach. Understanding these differences is essential for businesses and regulatory professionals to ensure compliance and adapt to the evolving regulatory landscape.

Legal framework and application

  • GPSD (Directive 2001/95/EC): As a directive, the GPSD sets out general safety objectives that EU member states must achieve, but it allows them flexibility in how these objectives are implemented within their national legal systems. This can lead to variations in enforcement and application across different countries.
  • GPSR (Regulation): The GPSR is a regulation, meaning it is directly applicable in all EU member states without requiring national transposition. This ensures uniformity across the EU, with consistent rules and standards for product safety, reducing discrepancies and enhancing enforcement consistency.

Scope and coverage

  • GPSD: The GPSD primarily targets consumer products not covered by specific sectoral legislation, providing a general safety framework. However, its scope is somewhat limited, as it does not explicitly address products governed by other directives or regulations.
  • GPSR: The GPSR expands on the GPSD’s foundation by applying to all consumer products, including those under sector-specific legislation. It targets new and emerging risks, especially those associated with digital and connected products, to guarantee safety for every product category.

Enforcement and compliance

  • GPSD: Enforcement under the GPSD is largely the responsibility of national authorities, leading to a decentralised approach that can result in variations across member states.
  • GPSR: The GPSR introduces stronger, more centralised enforcement mechanisms, including enhanced cooperation among national authorities and a centralised EU database for unsafe products (Safety Gate). It also establishes stricter penalties for non-compliance, creating a more robust framework for ensuring product safety.

screenshot of safety gate website

Safety Gate is the alert system for dangerous non-food products in the EU

Addressing innovation and emerging risks

  • GPSD: Established in 2001, the GPSD does not fully address the challenges posed by modern technologies, such as smart devices and the Internet of Things (IoT).
  • GPSR: The GPSR is designed to be forward-looking, with provisions for assessing and mitigating risks associated with new and connected technologies, ensuring the regulation remains relevant in an era of rapid technological advancement.

Transparency, consumer information, and traceability

    • GPSD: While the GPSD emphasises consumer information, particularly regarding product recalls and safety warnings, its mechanisms for ensuring transparency are less developed.
    • GPSR: The GPSR places a stronger emphasis on transparency and consumer rights, mandating clearer labelling, improved traceability, and better communication of product risks to consumers. It enhances the role of the Safety Gate portal, making it easier for consumers to access information about unsafe products. Additionally, the GPSR requires that products have an EU-based economic operator responsible for compliance, with contact details visible on the product, packaging, or accompanying documents.

      • graphic gpsr vs gpsd differences

      The differences between the general products safety directive and regulation

 

Compliance with GPSR

Ensuring compliance with GPSR involves several key steps:

  • Risk assessment: Before placing a product on the market, businesses should conduct a thorough risk assessment to identify potential hazards.
  • Safety checks: Regular testing and inspection of products are essential to ensure ongoing compliance.
  • Documentation: Maintain detailed records, including test reports and product information, to demonstrate compliance with GPSR.

Download checklist

  • EU-based economic operator: Non-EU manufacturers must appoint an EU-based economic operator (such as an importer, authorised representative, or distributor) who is responsible for the product’s compliance with EU regulations. This operator’s details must be clearly indicated on the product or its packaging.
  • Reporting: Any product found to be unsafe must be reported to the relevant authorities, and corrective actions, such as recalls, must be taken promptly.

Case study: Ahlberg-Dollarstore AB’s foldable beach chair recall

In 2022, Ahlberg-Dollarstore AB, a Swedish retail company, was forced to recall a foldable beach chair after a severe safety incident led to a consumer losing a finger. This case highlights the critical importance of conducting thorough risk assessments as part of the compliance process with the General Product Safety Regulation (GPSR).

The incident

A customer purchased a foldable beach chair from Ahlberg-Dollarstore AB and, while using it, suffered a significant injury when the chair’s folding mechanism malfunctioned, resulting in the amputation of a finger. The chair’s design, particularly the folding joints, posed an unforeseen hazard that was not adequately identified or mitigated before the product was marketed.

ahlberg dollarstore chair folding mechanism
The Ahlberg-Dollarstore chair that was recalled due to the dangerous folding mechanism

The recall

Following the incident, Ahlberg-Dollarstore AB initiated a product recall under pressure from consumer safety authorities. The recall process involved removing the chairs from stores, offering refunds to customers, and issuing a public safety warning. This incident, on top of harming the client, also damaged the company’s reputation and led to financial losses due to the recall and potential legal liabilities.

How a risk assessment could have prevented the accident

A comprehensive risk assessment is a vital step in ensuring product safety and preventing such accidents. Here’s how a proper risk assessment could have altered the outcome:

  • Identification of hazards:During the design phase, a detailed risk assessment would have identified the potential danger posed by the chair’s folding mechanism. By simulating real-world use and considering the forces applied during folding and unfolding, the company could have pinpointed the risk of injury.
  • Mitigation of risks:Upon identifying the hazard, the company could have taken steps to redesign the chair’s folding joints, perhaps by adding safety locks, smoother edges, or wider spaces to prevent fingers from getting trapped.
  • Testing and validation:Extensive testing of the final product, including stress tests and user trials, would have confirmed that the design changes effectively mitigated the risks. Continuous testing could have identified any remaining hazards that needed further attention.
  • Documentation and compliance:Maintaining detailed records of the risk assessment, design changes, and testing results would have ensured that Ahlberg-Dollarstore AB could demonstrate compliance with the GPSR. This documentation would have been crucial in showing due diligence in product safety.

 

6 risk assesment stages graphic
The six stages of a risk assessment

Lessons learned

The Ahlberg-Dollarstore AB case serves as a stark reminder of the consequences of overlooking thorough risk assessments. Not only did the lack of a proper risk assessment result in physical harm to a consumer, but it also led to significant reputational damage and financial loss for the company.

By prioritising risk assessments, businesses can identify potential hazards early in the product development process, implement effective safety measures, and avoid costly recalls and legal issues. This proactive approach not only ensures compliance with the GPSR but also protects consumers and enhances brand reputation.

The requirement for an EU-based economic operator

Under the GPSR, any product placed on the EU market must have an EU-based economic operator. This operator can be the manufacturer, an importer, an authorised representative, or a fulfilment service provider.

Responsibilities of the EU-based economic operator
The economic operator is responsible for:

  • Ensuring product safety compliance: The operator is responsible for confirming that the product has undergone the necessary conformity evaluations (when applicable) and meets the general safety requirements.
  • Documentation: They must maintain and provide access to documentation that demonstrates the product’s safety, such as risk assessments and test reports.
  • Cooperation with authorities: The operator is required to cooperate with market surveillance authorities, providing information and taking corrective actions if necessary.

Differences between the GPSD and GPSR

The General Product Safety Directive (GPSD) did not explicitly require an EU-based economic operator. This often made it difficult for market surveillance authorities to trace the source of non-compliant products, especially those imported from outside the EU. For example, in Germany, the provisions of the Product Safety Act (ProdSG, § 6 Abs. 1 Nr. 2) already included the requirement to indicate the authorised representative or the importer on the product.

The German Product Safety Act already required for consumer products to have the contact details of the EU-based economic operator on the product.

In contrast, the GPSR introduces a mandatory requirement for an EU-based economic operator, enhancing traceability and accountability. This ensures that there is always a responsible party within the EU who can be contacted by authorities and who can take necessary actions to address product safety issues.

Impact on non-EU businesses

For non-EU businesses, this requirement means they must appoint an EU-based economic operator if they wish to sell their products in the EU market. This operator will assume certain legal responsibilities related to the safety and compliance of the products, making it crucial for businesses to carefully select a reliable partner.

Practical steps for compliance

  • Identify an economic operator: Non-EU manufacturers should establish a relationship with an authorised EU representative, importer, or fulfilment service provider.
  • Documentation and communication: Ensure that the economic operator has access to all necessary safety documentation, including the mandatory risk assessment, and can respond quickly to any inquiries from market surveillance authorities.
  • Ongoing compliance: Regularly review and update agreements with the economic operator to ensure ongoing compliance with the GPSR.

Under the General Product Safety Regulation (GPSR), the address of the EU-based economic operator must be included on the product, its packaging, or in an accompanying document. This requirement ensures that market surveillance authorities and consumers can easily identify and contact the economic operator responsible for the product’s safety within the EU.

ukca and ce logo on product packaging example

Example of the indication of the AR on the packaging of the product.

GPSR and market surveillance

Market surveillance authorities play a crucial role in enforcing the GPSR. They are responsible for monitoring products on the market, conducting inspections, and taking action against non-compliant products.

Role of market surveillance authorities

These authorities have the power to:

  • Inspect products, conducting thorough evaluations to ensure they meet the GPSR’s safety standards.
  • Enforce corrective actions when a product is deemed unsafe, which can include recalls or withdrawals from the market.
  • Impose penalties for non-compliance with GPSR standards, ranging from fines to legal action.

Consequences of non-compliance

If a product is found to violate GPSR requierments, the consequences can be severe. These may include:

  • Significant financial fines for businesses that fail to comply.
  • Mandatory product recalls, with authorities requiring unsafe products to be removed from the market.
  • Legal action against businesses in cases of serious non-compliance.

Businesses must cooperate fully with market surveillance authorities to ensure compliance and avoid these penalties.

How GPSR affects different industries

The impact of the General Product Safety Regulation (GPSR) varies depending on the industry and the specific products involved. While the GPSR applies broadly to consumer products, many industries are also governed by sector-specific safety directives and regulations that set out more detailed requirements. For instance:

General consumer goods

For products not covered by specific legislation, such as certain household items, furniture, and general consumer goods, the GPSR provides the primary framework for ensuring product safety.

workout equipment

Most fitness equipment falls under the GPSR

Products like electronics or toys

These categories are subject to specific EU directives and regulations (e.g., the Low Voltage Directive, the Toy Safety Directive, RoHS directive or the Electromagnetic Compatibility Directive (EMCD). While these specific regulations take precedence in ensuring safety, the GPSR may still apply in a supplementary role to address any general safety aspects not covered by the specific legislation. One example would be a large wall hung watch, which can fall under the RoHS and EMC directive. The RoHS and EMC directive would not cover the hazard of the watch falling down from the wall potentially harming a consumer, while a risk assessment made under GPSR would.

Each industry must navigate both the general requirements of the GPSR (when applicable) and the specific regulations relevant to their products, ensuring comprehensive compliance across all applicable legal frameworks.

ukca and ce logo example on product packaging close up

Close up of the indication of the AR on the packaging.

GPSR in the context of E-commerce

E-commerce presents unique challenges for GPSR compliance. Online sellers and platforms such as Amazon, Etsy, and eBay must ensure that products sold through digital channels meet the safety standards set by the GPSR. However, it’s important to note a few specific details.

Responsibilities of online marketplaces

Platforms like Amazon, Etsy, and eBay are not only responsible for ensuring the safety of products they sell directly, but they also have obligations regarding third-party sellers.

  • Action against unsafe products: Under the GPSR, online marketplaces are required to take actions to prevent the sale of unsafe products, including removing listings of dangerous products reported by authorities within two working days. They must also process notices from non-authority sources, such as consumers, within three working days.
  • Product traceability: While online marketplaces must take steps to ensure the safety of products listed by third-party sellers, they are not directly responsible for conducting safety checks themselves. Instead, they must ensure that products sold on their platforms are traceable and that the necessary safety information, such as the contact details of the responsible economic operator in the EU, is provided. This operator could be the manufacturer, importer, authorised representative, or a fulfilment service provider established in the EU.

Consequences of non-compliance for online marketplaces

Non-compliance with the GPSR in the online marketplace can lead to significant penalties, including fines up to 4% of the annual worldwide turnover of the economic operator or the online marketplace involved. Additionally, platforms may suspend sellers who repeatedly list non-compliant products.

Common mistakes to avoid

Compliance with the General Product Safety Regulation (GPSR) can be complex, and businesses often make mistakes that could lead to significant consequences. Understanding these common errors can help prevent non-compliance.

  • Inadequate risk assessments: One of the most frequent mistakes is failing to conduct thorough risk assessments. Without identifying potential hazards, businesses may unintentionally market unsafe products, leading to recalls, fines, and damage to their reputation.
  • Insufficient documentation: Another common error is not maintaining proper records. The GPSR requires businesses to keep detailed documentation, including test reports, risk assessments, and technical files. Insufficient or disorganised documentation can make it difficult to demonstrate compliance during inspections or audits, e.g. a. risk assessment done but not documented is not a compliant risk assessment.
  • Overlooking e-commerce requirements: In the rapidly growing e-commerce sector, businesses sometimes overlook the specific requirements for selling products online. Ensuring that online listings comply with GPSR standards is crucial, especially as non-compliance can lead to severe penalties, including the suspension of sellers from major platforms.

Avoiding these mistakes is essential for maintaining product safety, ensuring compliance, and protecting the business from legal and financial risks.

The future of the General Product Safety Regulation

The GPSR is a dynamic regulation, designed to evolve in response to new challenges and technological advancements. Staying informed about potential updates is crucial for businesses aiming to maintain compliance and adapt to the changing regulatory landscape.

Addressing emerging risks

The GPSR is expected to continue adapting to address new risks, particularly those associated with digital and connected products. As technologies such as smart devices and the Internet of Things (IoT) become more prevalent, the regulation will likely incorporate specific provisions to mitigate these risks, ensuring that consumer safety is maintained in an increasingly connected world.

Potential updates and revisions

Future changes to the GPSR could introduce new requirements or strengthen existing ones. For example, enhanced traceability measures, stricter enforcement procedures, or additional obligations for online marketplaces might be included.

Businesses should stay proactive by monitoring regulatory changes and adjusting their compliance practices accordingly. By staying ahead of regulatory changes, companies can protect their customers, avoid penalties, and maintain a strong reputation in the market.

 

Podcast episode about the General Product Safety Regulation

In a recent podcast episode, experts Ferry Vermeulen and Roberth Jonsson discuss the General Product Safety Directive and the upcoming General Product Safety Regulation.
Key discussion points

  • Scope and replacement: The conversation explores the scope of the directive and the reasons for replacing it with the GPSR, highlighting the regulation’s broader application and stricter enforcement mechanisms.
  • Risk assessment requirements: They delve into the requirements for risk assessment in the new regulation, providing insights on conducting risk assessments for general product safety products.
  • Documentation and compliance: The podcast also covers the additional documentation needed for compliance with the GPSR, including the role of the economic operator, such as an authorised representative.
  • Impact on imports and digital products: The potential impact of the regulation on product imports is discussed, along with emerging topics like the proposed digital product passport.
  • Difference between a directive and a regulation: The experts explain the differences between a directive and a regulation, clarifying how the GPSR’s direct applicability in EU member states contrasts with the flexibility allowed under the previous directive.

Practical tips

The podcast concludes with practical tips for businesses preparing for the new regulation, emphasising the importance of staying informed and proactive to ensure compliance as the regulatory landscape evolves.
You can listen to the full episode here:

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“The General Product Safety Regulation is designed to ensure that all products, whether they require CE marking or not, meet a fundamental level of safety. It’s about creating a comprehensive safety net that catches any risks not fully addressed by other specific regulations, making sure that consumers are protected across the board.”
– Ferry Vermeulen, co-founder at 24hour AR –

 

Conclusion

Compliance with the General Product Safety Regulation (GPSR) is essential for businesses operating within the EU. By understanding the key requirements and implementing best practices, companies can ensure that their products are safe, avoid legal risks, and build trust with consumers. As the regulatory landscape continues to evolve, staying informed and proactive will be key to ongoing compliance.

Summary of key points:

  • Understanding responsibilities across the supply chain is essential, as manufacturers, importers, distributors, and online marketplaces each have specific obligations under the GPSR.
  • Maintaining proper documentation plays a key role in demonstrating compliance and ensuring that products adhere to safety standards.
  • Adapting to change is critical since the GPSR evolves with new challenges, particularly those arising from emerging technologies, requiring businesses to stay informed to remain compliant.
  • Emphasizing the importance of risk assessment is crucial, as thorough evaluations help identify and mitigate potential hazards linked to products.

 

Frequently Asked Questions (FAQ)

Penalties for non-compliance with the GPSR can be severe, ranging from significant fines to product recalls and legal action. The exact penalties depend on the severity of the violation and the risks posed to consumers. In extreme cases, businesses may face fines of up to 4% of their annual worldwide turnover.
The GPSR is specific to the EU but shares similarities with other international safety regulations. It provides a comprehensive standard for product safety, particularly for consumer goods, and is designed to work alongside other sector-specific regulations. While the GPSR offers a general safety framework, it complements other EU directives, such as those requiring CE marking.
Official EU websites, industry associations, and legal advisors are excellent sources for detailed information and updates on the GPSR. The European Commission’s Safety Gate portal is also a valuable resource for tracking unsafe products and understanding compliance requirements.
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