Understanding GPSR Compliance under Regulation EU 2023/988 for Consumer Products in the EU

Consumer product safety remains a top priority for manufacturers aiming to enter or expand within the European Union market. The new General Product Safety Regulation (GPSR), officially known as Regulation EU 2023/988, introduces updated requirements that will affect all consumer products sold in the EU starting from 13 December 2024. This regulation ensures that products are safe, traceable, and supported by thorough safety documentation. For manufacturers, especially those outside the EU, understanding and meeting these obligations is essential to maintain EU market access and avoid costly recalls or penalties.

Consumer product packaging showing safety labels and traceability codes

What GPSR Means for Consumer Product Compliance in the EU

The General Product Safety Regulation replaces the previous directive and strengthens the framework for product safety across the EU. It applies to all consumer products that are not covered by specific sectoral legislation. The key goal is to protect consumers by ensuring products placed on the EU market are safe throughout their lifecycle.

The regulation requires manufacturers and economic operators to:

• Conduct a product safety assessment before placing products on the market.

• Maintain technical documentation that supports product safety claims.

• Provide clear labelling and warnings to inform consumers of any risks.

• Ensure traceability of products through supply chains.

• Handle consumer complaints and report serious incidents.

• Cooperate with market surveillance EU authorities.

• Manage product recalls EU efficiently when necessary.

• Comply with rules for online marketplace compliance.

  
  

Obligations for Non-EU Manufacturers and the Role of the EU Responsible Person

Manufacturers based outside the EU face additional challenges under Regulation EU 2023/988. They must appoint an EU responsible economic operator to act on their behalf within the Union. This operator can be:

• An importer who brings the product into the EU.

• An authorised representative designated by the manufacturer.

• A fulfilment service provider handling storage and distribution.

  
  

This EU Responsible Person ensures compliance with GPSR requirements, including maintaining product safety documentation and liaising with authorities during market surveillance or recalls. Without this representation, non-EU manufacturers risk losing access to the EU market.

Key Requirements under Regulation EU 2023/988

Product Safety Assessment and Technical Documentation

Before launching a product, manufacturers must carry out a thorough safety assessment. This involves identifying potential hazards, evaluating risks, and implementing measures to mitigate them. The results must be documented in a technical file that includes:

• Product description and specifications.

• Risk assessment reports.

• Test results and certifications.

• Instructions for safe use.

• Details of any warnings or labels.

  
  

This documentation must be available for inspection by EU authorities for at least 10 years after the product is placed on the market.

Labelling, Warnings, and Traceability

Clear and visible labels are mandatory to inform consumers about product safety. Labels should include:

• Manufacturer or EU Responsible Person contact details.

• Safety warnings and instructions.

• Batch or serial numbers for traceability.

  
  

Traceability is crucial for effective product recall EU procedures. Each product must be identifiable through the supply chain to quickly isolate and remove unsafe items.

Complaint Handling and Incident Reporting

Manufacturers and economic operators must establish systems to collect and manage consumer complaints. If a serious incident occurs, such as injury or death linked to a product, it must be reported promptly to the relevant national authorities. This enables swift action to protect consumers and prevent further harm.

Cooperation with Market Surveillance Authorities

EU market surveillance authorities have the power to inspect products, request documentation, and enforce compliance. Manufacturers and their EU Responsible Persons must cooperate fully, providing access to information and facilitating investigations.

Online Marketplace Compliance

With the rise of e-commerce, GPSR also covers products sold through online marketplaces. Platforms must ensure that products comply with safety requirements and that sellers provide necessary documentation. This adds an extra layer of responsibility for both sellers and marketplaces to maintain consumer product compliance EU.

Close-up of a product label with safety warnings and batch number for traceability

How AF Pharma Supports GPSR Compliance and EU Market Access

Navigating the complex requirements of the General Product Safety Regulation can be challenging, especially for startups, SMEs, and international brands. AF Pharma GPSR offers expert regulatory consulting to help manufacturers achieve full GPSR compliance and secure EU market access efficiently.

Our services include:

• Acting as your EU Responsible Person or supporting your appointed representative.

• Conducting comprehensive product safety assessments and preparing product safety documentation.

• Performing detailed EU product label review to ensure all warnings and information meet GPSR standards.

• Implementing traceability systems to support swift product recall EU processes.

• Advising on online marketplace compliance and complaint handling procedures.

• Guiding cooperation with market surveillance EU authorities to avoid enforcement issues.

  
  

By partnering with AF Pharma, manufacturers gain peace of mind knowing their products meet the latest product safety regulation EU requirements and are ready for the EU market.

Preparing for GPSR Compliance by December 2024

The deadline for compliance with Regulation EU 2023/988 is 13 December 2024. Manufacturers should start preparing now to avoid disruptions in their EU sales. Key steps include:

• Reviewing current product safety documentation and updating it to meet GPSR standards.

• Identifying or appointing an EU responsible economic operator if based outside the EU.

• Conducting a thorough EU product label review.

• Establishing systems for complaint handling, incident reporting, and traceability.

• Training staff and partners on GPSR obligations and processes.

  
  

Early preparation helps prevent costly delays, fines, or forced product withdrawals.

Manufacturers aiming to sell consumer products in the EU must understand and comply with the new General Product Safety Regulation under Regulation EU 2023/988. This regulation demands clear safety assessments, traceability, and cooperation with authorities to protect consumers and maintain market access.