The European Union’s product safety landscape has undergone a significant transformation with the introduction of the General Product Safety Regulation (GPSR) – Regulation (EU) 2023/988. This comprehensive regulation, which replaced the General Product Safety Directive (GPSD), came into full effect on December 13, 2024, marking a crucial milestone for businesses operating in the EU market. This article explores the key aspects of GPSR adherence and highlights its importance for economic operators in today’s digital and globalized marketplace.

The GPSR establishes essential safety rules for consumer products sold or made available on the EU market. It aims to ensure a high level of consumer protection while improving the internal market’s functioning through harmonized safety requirements. To ensure compliance with these requirements, businesses can appoint a Responsible Person for GPSR.

3 key differences between GPSR and GPSD

• Unlike its predecessor, the GPSR is a regulation rather than a directive, meaning it applies directly in all EU member states without requiring national implementation legislation.
• The new GPSR regulations focus significantly on digital aspects of product safety, addressing challenges posed by emerging technologies and connected products.
• The regulation covers a broader range of products and introduces clearer responsibilities for various economic operators.

The GPSR applies to all consumer products placed or made available on the EU market, including:

• Products sold online and through traditional channels;
• New, used, repaired, or reconditioned products;
• Products incorporating digital elements and connected devices.

The regulation explicitly exempts:

• Medicinal products for human or veterinary use;
• Food and feed;
• Living plants and animals, genetically modified organisms, and microorganisms in contained use;
• Animal-derived products and by-products;
• Plant protection products;
• Transport equipment operated by a service provider;
• Low-risk aircraft;
• Antiques;
• Products clearly marked to be repaired or reconditioned prior to use.

5 key GPSR provisions and labelling requirements for EU markets

1. Enhanced obligations for economic operators

The GPSR clearly defines responsibilities for:

• Must ensure product safety, maintain technical documentation, and implement traceability systems;
• Must verify that products comply with EU safety standards before placing them on the market;
• Must act with due care and verify that products bear required markings and documentation;
• Must ensure the safety of the products they handle and cooperate with authorities.

2. Online marketplace responsibilities

With e-commerce sales representing over 20% of retail in the EU, the GPSR introduces specific obligations for online marketplaces, including tax management for online platforms:

• Implementing robust product safety verification processes;
• Establishing effective mechanisms for identifying and removing unsafe products;
• Cooperating with market surveillance authorities;
• Maintaining a single point of contact for product safety matters;
• Providing clear information to consumers about product risks.

3. Enhanced product traceability

The GPSR strengthens traceability and labelling requirements for all products sold in the EU market:

• Mandatory inclusion of product identification information;
• Implementation of digital solutions such as QR codes or RFID tags for improved traceability;
• Requirements for maintaining supply chain documentation for at least 10 years;
• Establishment of more efficient recall procedures.

4. Risk assessment framework

The regulation introduces a comprehensive risk assessment approach that considers. Businesses must consider GPSR labelling requirements during the risk assessment process to ensure product
transparency:

• Traditional physical safety risks;
• Digital risks and cybersecurity vulnerabilities;
• Foreseeable misuse scenarios;
• Cumulative risks from multiple products;
• Specific risks to vulnerable consumers (children, elderly, persons with disabilities).

5. Market surveillance and enforcement

The GPSR empowers authorities with enhanced tools for market surveillance:

• Increased powers for conducting inspections and product testing;
• Authority to order product recalls and withdrawals;
• Ability to impose significant penalties for non-compliance;
• Establishment of the EU Product Safety Gate (formerly RAPEX) as a central notification system.

GPSR implementation timeline

• December 13, 2023: GPSR entered into force
• December 13, 2024: Most provisions became applicable
• December 13, 2025: Extended deadline for certain online marketplace provisions

5 reasons to meet GPSR requirements for EU market success

1. Legal and financial consequences

Non-compliance with GPSR can result in:

• Substantial fines of up to 4% of annual turnover or €10 million, whichever is higher;
• Mandatory product recalls and market restrictions;
• Legal liability for damages caused by unsafe products;
• Exclusion from public procurement opportunities.

2. Brand reputation and consumer trust

• Conformity demonstrates a commitment to consumer safety, building trust and enhancing brand reputation;
• Studies show that 78% of EU consumers consider product safety a top priority when making purchasing decisions;
• Safety incidents can cause irreparable damage to brand image, with negative impacts lasting for years.

3. Market access

• Adhering to EU GPSR rules is a prerequisite for accessing the EU’s 450 million consumer market;
• Products failing to meet requirements face rejection at borders or removal from distribution channels;
• Adherence to regulations facilitates smoother operations across all EU member states.

4. Competitive advantage

• Organisations that prioritise regulatory adherence and integrate safety considerations early in product development gain strategic advantages;
• Proactive conformity can serve as a differentiator in competitive markets;
• Streamlined regulatory processes can reduce time-to-market for new products.

5. Cost efficiency

• Following GPSR regulations reduces the likelihood of product recalls;
• The average cost of a product recall in the EU exceeds €1.5 million, not including brand damage;
• Early safety integration is significantly more cost-effective than remediation after market entry.

6 practical steps to achieve GPSR conformity and ensure product safety

1. Comprehensive risk assessment

• Conduct thorough risk assessments throughout the product lifecycle;
• Document assessment methodologies and results;
• Consider both physical and digital safety aspects;
• Regularly review and update risk assessments.

2. Technical documentation management

• Maintain comprehensive technical files for each product;
• Include test reports, risk assessments, and conformity declarations;
• Ensure documentation is readily available for authorities upon request;
• Implement version control for documentation updates.

3. Traceability implementation

• Establish clear product identification systems;
• Implement digital traceability solutions where appropriate;
• Maintain accurate supply chain records;
• Regularly test traceability systems through mock recalls.

4. Consumer safety information

• Provide clear safety information and warnings to consumers;
• Ensure instructions are available in appropriate languages;
• Implement effective methods for communicating safety updates;
• Consider digital solutions for providing real-time safety information.

5. Post-market surveillance

• Monitor product performance in the market;
• Establish effective complaint-handling procedures;
• Analyze safety data to identify emerging risks;
• Implement procedures for rapid response to safety issues.

6. Training and awareness

• Ensure all relevant staff understand GPSR requirements;
• Provide regular training on conformity procedures;
• Foster a culture of safety throughout the organization;
• Engage suppliers and partners in compliance efforts.

As the GPSR reshapes the EU’s product safety landscape, businesses must adapt to its enhanced requirements to ensure continued market access. Far from being merely a regulatory burden, GPSR compliance represents an opportunity for organizations to demonstrate their commitment to product safety and consumer protection, ultimately contributing to sustainable business growth and consumer trust.

By embracing the principles of GPSR and proactively implementing conformity measures, businesses can navigate the complexities of the modern product safety landscape with confidence while building stronger relationships with their customers and stakeholders.