General Product Safety Regulation (GPSR): Product Safety & Market Access in the EU

Navigating GPSR Compliance with Biorius

The General Product Safety Regulation (EU) 2023/988, or GPSR, is the new legal framework that applies to a broad range of consumer products not covered by specific sectoral regulations like cosmetics, medical devices, toys, or food.

From candles, detergents, and room sprays to cosmetic accessories and pet-use products, GPSR aims to ensure that these “general products” are safe, traceable, and legally compliant within the European Union.

At Biorius, we help brands meet their obligations under GPSR with tailored regulatory support, ensuring your products remain safe, compliant, and ready for sale in the European Union.

Biorius Services Under GPSR

We support your compliance from start to finish, with tailored evaluations based on your product type and intended use. Our regulatory experts deliver everything you need to market your products confidently in the EU.

Our Services Include

Product Classification: Determining if your product qualifies under GPSR or other legislation.
Substance Hazard Identification: Classification under CLP (EC) 1272/2008 based on raw material data.
Toxicological Risk Assessment: Route-specific safety evaluations for typical use (inhalation, dermal, etc.).
Label & Packaging Review: Full compliance with mandatory labeling elements under GPSR and CLP, including pictograms and precautionary statements.
Guidance on Required Testing: For specific products like candles, we inform you of mandatory safety tests (NF EN 15493, 15426, etc.) required for market access.
Final Compliance Report: A technical report summarizing the risk analysis and label compliance to support legal marketing in the EU.

What Types of Products Are Covered?

If your product is a chemical mixture or article intended for consumers, and not regulated under cosmetics, GPSR likely applies.

Examples include:

Who Does It Apply To?

GPSR applies to manufacturers, importers, distributors, online marketplaces, and fulfillment service providers offering non-harmonized consumer products such as home fragrances, makeup tools, candles, toys, and other general goods. Products sold online and those imported from outside the EU are also in scope.

Non-compliance with GPSR can lead to product recalls, market bans, and significant penalties. For brands looking to access the EU market, aligning with GPSR is essential to protect consumer safety and maintain business continuity.

Need an EU-Based Authorized Representative?

If your company is not located within the EU, you must appoint an Authorized Representative to ensure product traceability, safety documentation, and compliance communication with EU authorities.

Biorius can act as your EU Authorized Representative under GPSR and support you in:

Poison Centre Notification (PCN): Are You Compliant?

If your product contains hazardous mixtures, PCN compliance is not optional, it’s mandatory. The EU requires companies to submit toxicological and product information to national poison centres to ensure consumer safety and rapid emergency response.

At Biorius, we help you understand whether your product requires a PCN, and we handle the submission process from start to finish.

Streamline Compliance Across Your Entire Product Portfolio with MyApps

Managing regulatory obligations for both cosmetic and non-cosmetic products can be challenging—but with MyApps, Biorius makes it simple.

MyApps is our exclusive, secure digital platform that allows you to oversee all regulatory projects in one place—whether they concern cosmetics, detergents, general consumer goods (GPSR), or safety data sheets (SDS). Designed to centralize and simplify your compliance journey, MyApps gives you full control and real-time visibility over your entire portfolio.