GPSR Registration

Navigating the General Product Safety Regulation (GPSR): What Manufacturers Need to Know

As the regulatory landscape in the EU continues to evolve, compliance with the General Product Safety Regulation (GPSR) is now a critical consideration for manufacturers, importers, and distributors. GPSR aims to ensure the safety of non-food consumer products across the EU, fostering a harmonized framework that protects consumers and enhances market transparency.

At AF Pharma, we are dedicated to helping businesses navigate these regulations seamlessly. Here's what you need to know about GPSR and how it impacts your product strategy.

What is the General Product Safety Regulation?

The GPSR, replacing the General Product Safety Directive (2001/95/EC), establishes robust requirements for ensuring the safety of consumer products in the EU. It applies to all products not covered by sector-specific legislation or to aspects not addressed by other regulations.

Key Requirements Under GPSR

1. Ensuring Product Safety

Manufacturers must conduct a comprehensive risk assessment for their products, taking into account:

The product's intended use and foreseeable misuse.
The characteristics and composition of the product.
Vulnerable groups such as children, the elderly, and persons with disabilities.

2. Traceability Obligations

To enhance market surveillance, businesses must:

Clearly identify products with batch, type, or serial numbers.
Provide details of the manufacturer or importer on the product or packaging.
Maintain records to ensure traceability along the supply chain.

3. Market Surveillance

GPSR strengthens market surveillance obligations, requiring economic operators to cooperate with authorities in cases of non-compliance or safety concerns.

4. Online Marketplaces

Online platforms are now subject to stricter rules under GPSR, ensuring that products sold online meet EU safety standards.

Common Challenges

Evolving Definitions of Safety

Safety now includes cybersecurity risks and emerging hazards, requiring innovative approaches to risk management.

Supply Chain Complexity

Ensuring traceability across global supply chains is increasingly challenging, particularly for businesses sourcing from non-EU countries.

Compliance with Digital Tools

GPSR encourages the use of digital tools such as QR codes for traceability, adding a layer of technical expertise for implementation.

How AF Pharma Can Help

At AF Pharma, we offer tailored support to meet GPSR requirements:

Risk Assessments: Comprehensive analysis to ensure product safety.
Compliance Documentation: Assistance with technical files and traceability records.
Market Surveillance Support: Guidance on responding to safety concerns and authority inquiries.
Digital Compliance Solutions: Implementation of tools for labeling, traceability, and consumer communication.

Why Compliance Matters

The GPSR represents a significant shift towards enhanced product safety and consumer trust in the EU. By adhering to its requirements, businesses not only avoid regulatory penalties but also strengthen their market position.

At AF Pharma, we are committed to helping you achieve full compliance and thrive in a competitive market.

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