Understanding the EU General Product Safety Regulation (GPSR) & Importance of an Authorised Representative for Non-EU Manufacturers

As the European Union continues to prioritize consumer safety, compliance with the General Product Safety Regulation (GPSR) is not just a legal requirement but also a key business strategy for manufacturers worldwide. This regulation ensures products placed on the EU market meet stringent safety standards, providing consumers with confidence in product safety and integrity.

In this blog, we explore the critical aspects of GPSR and highlight why appointing an EU Authorised Representative (AR) is essential for manufacturers outside the European Union.

What is the General Product Safety Regulation (GPSR)?

The GPSR, officially effective from December 13, 2024, modernizes product safety rules across the European Union. It aims to enhance consumer protection by:

• Harmonizing safety standards across all member states.

• Ensuring robust traceability and transparency throughout the supply chain.

• Facilitating efficient recall processes and risk management systems.

• Implementing stricter obligations for online platforms and marketplaces.

These changes significantly impact manufacturers, importers, distributors, and especially online sellers. Any non-compliance with GPSR could result in penalties, market restrictions, or product recalls.

Key Requirements Under GPSR

1. Risk Assessment and Documentation: Manufacturers must conduct thorough risk assessments and prepare detailed technical documentation proving their products meet EU safety requirements.

2. Clear Labelling and Information: Products must be clearly labelled, providing comprehensive instructions, warnings, and traceability information, enabling consumers to make informed choices.

3. Product Traceability: Businesses must ensure effective traceability by maintaining accurate supply chain records and providing product details, including batch numbers and contact details of the responsible entities.

4. Rapid Alert System (Safety Gate): Companies must promptly notify authorities if a product poses safety risks. Compliance with the Safety Gate system (formerly RAPEX) is mandatory for timely alerts and recalls.

Why is an EU Authorised Representative Crucial for Non-EU Manufacturers?

An EU Authorised Representative (AR) is a legally designated entity based within the European Union that acts on behalf of manufacturers located outside the EU. Having an AR is not merely optional but a critical compliance strategy under GPSR.

Here are key reasons why appointing an AR is beneficial:

• Legal Compliance: An AR ensures your products comply with all GPSR obligations, reducing regulatory risks and avoiding costly penalties.

• Market Surveillance Communication: The AR acts as a central point of contact between manufacturers and EU regulatory authorities, streamlining communication and regulatory responses.

• Consumer Confidence: With an AR, manufacturers enhance trust among European consumers, retailers, and online marketplaces by demonstrating a clear commitment to regulatory compliance and product safety.

• Efficient Market Access: Having an EU-based representative accelerates market entry and facilitates smoother interactions with distributors, importers, and regulatory bodies.

How DorukWell GmbH Supports Your EU General Product Safety Regulation (GPSR) Compliance

DorukWell GmbH provides specialized consultancy services, acting as your trusted EU Authorised Representative. Our team helps ensure compliance with GPSR through comprehensive product risk assessments, technical documentation audits, clear labelling reviews, and ongoing regulatory guidance.

We also assist in managing Safety Gate notifications and interactions with market surveillance authorities, making sure your business meets and exceeds the EU's stringent safety standards.

Final Thoughts

Compliance with the GPSR is essential for any business targeting the EU market. Non-EU manufacturers, in particular, benefit significantly from having an EU-based Authorised Representative to navigate complex regulatory landscapes efficiently and confidently.

By choosing DorukWell GmbH as your AR, you secure your business's regulatory standing, protect consumer trust, and maintain uninterrupted access to Europe's vast marketplace.

Contact DorukWell GmbH today to learn more about our GPSR Compliance and EU Authorised Representative services and ensure your business thrives within the EU market.