Healthcare & Medical Devices
Compliance with CBAM in the medical field depends on accurate, cross-border emissions tracking
Product & Food Safety
Regulation — General Product Safety (GPSR)
GPSR
The EU General Product Safety Regulation
Set to apply from December 13, 2024, the GPSR modernises the EU's product safety framework, introducing stricter rules for online marketplaces and all economic operators. ARTEM ensures your products and documentation are ready for this new standard of consumer protection.
The GPSR (EU) 2023/988 replaces the old General Product Safety Directive, creating a harmonised safety net for nearly all non-food consumer products sold in the EU market. It strengthens market surveillance and introduces clear obligations for manufacturers, importers, and online platforms to ensure only safe products reach consumers.
The GPSR (EU) 2023/988 replaces the old General Product Safety Directive, creating a harmonised safety net for nearly all non-food consumer products sold in the EU market. It strengthens market surveillance and introduces clear obligations for manufacturers, importers, and online platforms to ensure only safe products reach consumers.
A New Baseline for Product Safety in the EU
1
Expanded Scope
The regulation explicitly covers products sold online and offline, placing clear responsibilities on online marketplaces to combat the sale of unsafe goods.
2
Stricter Traceability
Enhanced traceability requirements mean products must be identifiable with manufacturer details, contact information, and batch numbers to facilitate recalls.
3
Focus on New Risks
Traders, customs brokers, and third-party representatives acting on behalf of importers must ensure timely CBAM registration, quarterly reporting, and certificate surrender from 2026. Non-compliance can lead to fines of €10–€50 per tonne of CO₂.
Core Obligations
Under the GPSR
To comply with the GPSR, economic operators must meet several key requirements before placing a product on the market.
Appoint an EU Responsible Person
Every product sold in the EU must have a designated economic operator (like a manufacturer, importer, or authorised representative) based in the EU who is responsible for compliance.
Conduct a Thorough Risk Assessment
Manufacturers must perform an internal risk analysis for their products, considering potential new risks like cybersecurity and mental health impacts.
Create & Maintain Technical Documentation
Detailed technical documentation must be created and kept for 10 years, containing at a minimum a product description and its essential characteristics.
Ensure Clear Labelling & Traceability
Products and their packaging must be marked with manufacturer/importer details, contact information, and type/batch/serial numbers.
Who needs to comply?
The General Product Safety Regulation (GPSR) applies to all businesses selling or distributing non-food consumer goods within the EU. This includes both physical and online channels.
1
Manufacturers
Companies producing consumer goods inside or outside the EU.
2
Importers & Distributors
Entities placing goods on the EU market.
3
Online Marketplaces & Fulfillment Providers
Platforms hosting or shipping products directly to EU consumers.
4
Authorized Representatives
Organizations representing non-EU brands in ensuring compliance.
The Artem Solution:
Streamlining GPSR Compliance
From Hardware to Strategy
Your Partner in General Product Safety (GPSR) Compliance
