General Product Safety Regulation

The General Product Safety Regulation (GPSR) establishes essential requirements for consumer products that are not covered by specific sector legislation (e.g., toys, cosmetics, medical devices) to protect consumer health and safety while ensuring the proper functioning of the internal European market.

The GPSR provides that economic operators shall place or make available on the market only safe products. Products are presumed to be in conformity with this general safety requirement if they either conform to relevant European standards as far as the risks and risk categories covered by those standards are concerned, or in their absence, to national requirements (which shall be compliant with EU law). 

Manufacturers, who may mandate an authorised representative to perform their obligations on their behalf, are required to draw up technical documentations and to carry out internal risk assessments taking due account of the precautionary principle and various aspects, such as:

• The characteristics of the product
• Its effects on other products & vice versa
• The categories of consumers using it
• Its presentation
• Its appearance

While manufacturers are the primary economic operators in charge with the compliance of the general safety requirements, every actors within the supply chain (importers and distributors) are responsible for checking that the upstream supply chain did comply with their obligations under the GPSR.

In case the product cannot be presumed safe (because of the absence of relevant European standard and national requirements), economic operators shall also rely on:

• International standards and agreements
• Voluntary certification schemes, product safety codes of good practice
• European Commission recommendations or guidelines
• State of the art and technologies
• Reasonable consumer expectation

Most Absorbent Hygiene Products (baby diapers, menstrual products) fall entirely within the scope of the GPSR, while incontinence products are covered by the Medical Products Regulations. Where products are subject to specific safety requirements imposed by Union law, such as incontinence products, the GPSR applies only to those aspects and risks or categories of risks which are not covered by those requirements.

Enhanced Obligations for Economic Operators

Under the new regulation, manufacturers are required to provide consumers with detailed information on potential risks associated with their products and take appropriate measures to prevent such risks. New requirements have been introduced to ensure product traceability throughout the supply chain.

To comply with the GPSR, manufacturers must conduct a thorough risk assessment of their products. The results of this assessment must be documented and included in an in-house product dossier that can be presented to national authorities during enforcement actions.

Economic operators are required to cooperate with market surveillance authorities, ensuring that only safe products are available on the market. They must also maintain proper documentation to help trace dangerous products, if necessary.

Digital Transformation and Online Marketplaces

The GPSR introduces new provisions aimed at addressing the challenges posed by online sales and digital marketplaces. E-commerce platforms are now required to verify the safety of products sold through their services, ensuring they meet the same standards as those in brick-and-mortar stores.

Strengthened Role of Member States

Under the GPSR, Member States continue to have a central role in enforcing product safety. They are responsible for appointing authorities to carry out market surveillance and enforcement actions. Additionally, they must ensure that penalties for non-compliance are strengthened and aligned across the EU.

The GPSR also grants surveillance authorities expanded monitoring and intervention powers to enhance the efficiency of enforcement measures, allowing them to issue recalls or bans on unsafe products more swiftly.

Improved RAPEX System (Now called Safety Gate)

The regulation maintains the rapid alert system (previously known as RAPEX, now referred to as Safety Gate) to quickly share information about dangerous products among Member States and the European Commission. The system ensures that relevant authorities are informed promptly when a dangerous product is identified.

Safety Gate allows for the exchange of rapid alert notifications between the EU and non-EU countries. 

New Emergency Measures

The GPSR enhances the emergency measures that the Commission can take in response to serious product risks. Under the new regulation, the Commission can adopt formal decisions requiring Member States to take immediate actions, such as banning unsafe products, recalling them from consumers, or withdrawing them from the market.

For more information, read the EDANA guidance document for the nonwovens and related industry on the implementation of the GPSR and visit the European Commission's website on product safety and consumer protection.