General Product Safety Regulation (GPSR 2023/988) Explained | QNET BV

Introduction

The European Union has adopted the General Product Safety Regulation (GPSR) 2023/988, which replaces the previous General Product Safety Directive (GPSD 2001/95/EC)**. The GPSR introduces stricter safety requirements and modernized rules to ensure that all products on the EU market are safe, particularly addressing challenges posed by online sales, globalization, and emerging technologies.

For manufacturers, importers, and distributors, GPSR 2023/988 compliance is essential to access and operate in the European Union market. Below is an overview of the regulation and what businesses must do to comply.

Why the GPSR Matters

The GPSR ensures that products not covered by sector-specific legislation (such as CE marking directives for medical devices, machinery, or toys) remain safe for consumers. It applies to all consumer products that are placed, made available, or sold in the European Union, whether through traditional or online channels.

With an increasing focus on product safety, the GPSR strengthens the regulatory framework to address modern challenges such as:

Cross-border e-commerce and online platforms.
Traceability of products in a globalized supply chain.
Product risks from emerging technologies, such as connected products and IoT.

Why is this Important for Businesses?

The GPSR directly impacts manufacturers, importers, and distributors operating in the EU, as well as non-EU businesses looking to enter the EU market. Non-compliance can result in severe consequences, including:

Product recalls or market withdrawals initiated by EU authorities.
Fines and penalties for placing unsafe products on the market.
Loss of consumer trust, which can damage a company’s brand reputation and competitiveness.

Ensuring compliance with GPSR 2023/988 is not just a regulatory obligation but a strategic necessity for businesses to safeguard market access, reduce risks, and demonstrate their commitment to consumer safety.

Key Changes Introduced by the GPSR

1. Stricter Product Safety Requirements

Products must be safe under normal and foreseeable conditions of use, taking into account:

Chemical, physical, mechanical, and electrical risks.
Risks to vulnerable populations, such as children and older people.
Emerging risks, including cybersecurity vulnerabilities in innovative products.

2. Mandatory Technical Documentation

Manufacturers must prepare and maintain Technical Documentation to prove compliance with safety requirements (Article 9). This file must include:

Risk Assessment: Identify hazards, mitigation measures, and residual risks.
Safety Features: Details on product design, technical specifications, and manufacturing.
Instructions for Use: Clear and safe usage instructions, maintenance, and warnings.
Testing Results: Evidence of compliance with applicable safety standards.

Manufacturers must retain this documentation for 10 years after placing the product on the EU-market.

3. Traceability and Labeling Requirements

Products must include clear, visible, and legible labeling information:

Manufacturer’s name, registered trade name, and contact details.
Contact details of the EU-based Economic Operator (if the manufacturer is outside the EU).
If affixing this information to the product is not feasible, it can be placed on the packaging or accompanying documents.

Traceability measures must include batch numbers or other identifiers to ensure product identification.

4. The Role of Economic Operators

Under Article 16, the GPSR requires that a non-EU manufacturer appoint an EU-based economic operator to ensure compliance. This can be:

An EU Authorized Representative (EAR).
An importer or distributor established in the EU.

The economic operator’s responsibilities include:

Retain technical documentation and provide it to authorities when requested.
Cooperating with EU market surveillance authorities during compliance checks.
Ensuring product labeling, safety, and corrective actions are in place.

Appointing an Authorized Representative such as QNET BV for businesses outside the EU ensures seamless compliance and representation.

5. Online and Distance Sales Compliance

Products sold through e-commerce and online marketplaces must comply with the same safety and traceability requirements as physical goods. Online platforms are now required to:

Ensure that only compliant products are made available.
Display the name and contact details of the responsible economic operator for each product.

6. Post-Market Surveillance and Corrective Actions

The GPSR emphasizes Post-Market Surveillance (Article 19). Economic operators must:

Monitor product safety throughout its lifecycle.
Investigate complaints, feedback, and incidents.
Take corrective actions, including recalls or warnings, to address safety risks.
Notify authorities of any serious risks associated with their products.

Who Needs to Comply with GPSR 2023/988?

The regulation applies to:

Manufacturers: Both EU-based and non-EU manufacturers are placing products on the EU market.
Importers and Distributors: Operators making products available in the EU supply chain.
Online Marketplaces: Platforms facilitating sales to EU consumers.

Non-EU manufacturers must appoint an Authorized Representative to serve as the contact point for regulatory authorities.

How QNET BV Can Help

At QNET BV, we specialize in acting as an EU Authorized Representative (EAR) to help non-EU manufacturers comply with GPSR 2023/988 and other EU regulations.

Our services include:

Acting as the official EU contact point for market surveillance authorities.
Reviewing and maintaining your Technical Documentation for compliance.
Ensuring correct labeling and traceability requirements.
Providing Post-Market Surveillance (PMS) support, including incident management.
Keeping you informed of regulatory changes and obligations.

By partnering with QNET BV, you ensure that your products meet the EU’s safety requirements, enabling smooth and secure access to the European market.

Conclusion

The General Product Safety Regulation (GPSR 2023/988) is a critical regulation for manufacturers, importers, and distributors placing non-CE-marked products on the EU market. It modernizes product safety requirements, strengthens traceability, and introduces stricter obligations for online sales.

Non-EU manufacturers must work with an EU-based economic operator to remain compliant. By appointing QNET BV as your Authorized Representative, you can confidently meet these requirements and ensure consumer safety and regulatory compliance.

QNET BV
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