EU Regulation on General Product Safety – Meeting the New Requirements
Assembling safety and quality in all toys and hardgoods
First Published: January 2025
The General Product Safety Regulation (GPSR) 2023/988 is a landmark piece of legislation designed to enhance product safety across the European Union (EU). The GPSR replaces the older General Product Safety Directive (GPSD) and came into effect in December 2024.
In light of rapid technological advances, increased e-commerce, and evolving market practices, the GPSR provides a comprehensive approach to ensuring that consumer products sold in the EU market are safe.
Whether you’re a manufacturer, importer, distributor, or online marketplace provider, understanding and fulfilling your obligations under the GPSR is essential for safeguarding consumer health and safety. In this article, we’ll explore what the GPSR entails, its key provisions, and the obligations placed on economic operators in order to comply with the regulation.
What is the General Product Safety Regulation?
Effective in December 2024, GPSR represents a significant advancement in consumer protection within the EU.
This regulation amends standardisation procedures in EU Regulation No 1025/1012 and Directive 2020/1828, and supersedes the General Product Safety Directive (GPSD, Directive 2001/95/EC) and Directive 87/357/EEC. It aims to modernise the framework for product safety, addressing challenges posed by digitalisation and increasingly complex supply chains.
The GPSR outlines essential new requirements for businesses to ensure the safety and compliance of consumer products marketed to the EU.
What products are covered under GPSR?
GPSR covers all consumer products, including those sold online, new, used, repaired, or reconditioned and applies to non-food consumer goods for which there is no specific EU legislation.
Whilst some of the provisions of this Regulation, such as most of the obligations of economic operators, should not apply to products covered by Union harmonisation legislation, certain other provisions of this Regulation are complementary to Union harmonisation legislation and should therefore apply to such products.
For products covered by sector-specific Union harmonisation legislation, such as toys, the Regulation is only applicable to the aspects, risks or categories of risks that are not addressed by those specific harmonisation legislations.
However, there are certain chapters of the regulation that are applicable to ALL products, either covered by harmonisation legislation or not.
Additionally, GPSR does not apply to:
- Medicinal products for human or veterinary use
- Food and feed
- Living plants and animals, genetically modified organisms and microorganisms in contained use
- Animal-derived and by-products,
- Plant protection products
- Transport equipment operated by a service provider
- Low-risk aircraft
- Antiques
- Products clearly marked to be repaired or reconditioned prior to use
This broader scope is especially pertinent given the growing role of online commerce and the increasing variety of products on the market. If your product doesn’t fall under any specific EU safety rules, it will nonetheless be subject to the GPSR’s provisions.
What are the key new requirements of GPSR?
The major changes introduced by the EU General Product Safety Regulation (GPSR) include the following:
Direct applicability: Unlike the General Product Safety Directive (GPSD), the GPSR is directly applicable across all EU/EEA member states, ensuring uniformity and helping to impose clear and detailed rules which leave no scope for divergent transposition by the Member States.
New obligations for Economic Operators: Economic operators, including manufacturers, importers, authorised representatives or fulfilment service providers, are now required to conduct thorough risk assessments throughout the product lifecycle.
Requirement for technical documentation: GPSR requires manufacturers to provide, maintain, and update the technical documentation as evidence of product safety. Key elements of a technical documentation include general product description, risk analysis, result of the test reports, reference of relevant EU standards or other elements used to assess the safety of the product, instructions and labels information, and traceability information.
Requirement for an EU Responsible Person: A product covered by the Regulation shall not be placed on the market unless there is an economic operator established in the Union who is responsible according to Regulation (EU) 2019/1020 on market surveillance and compliance. This applies to manufacturers outside the EU, who must designate a local entity to serve this role.
Enhanced labelling requirement for traceability and identification: GPSR requires to have clear identification of the product and the manufacturer (including product type, batch, or serial number, manufacturer’s name, registered trade name, or registered trade mark, manufacturer’s postal and electronic address), any warnings and age suitability for children if applicable.
Stricter Waste disposal requirements: Any products that have been recalled should be discarded while taking into account the environmental and sustainability goals outlined in relevant laws.
Enhanced market surveillance: National authorities have more powers to conduct more effective inspections of products and take action against unsafe ones.
Consumer empowerment: The regulation provides consumers with more information and tools to report unsafe products.
Providers of online marketplaces: Providers must:
- Designate a single contact point for communication with market surveillance authorities and with consumers
- Register in the Safety Gate Portal
- Ensure internal processes for product safety
- Notify national authorities/market surveillance authorities about unsafe products
- Comply with the requirements of Regulation (EU) 2022/2065 on digital services and list mandatory information about the product on their online interface
- Cooperate with authorities and relevant economic operators in case of unsafe products
How to comply with GPSR?
GPSR introduces several new requirements and enhances existing requirements for consumer product safety. To ensure full compliance with GPSR, consulting an expert like Eurofins Softlines & Hardlines is advisable.
In a nutshell, compliance can be classified into two perspectives: operational and product safety.
Operation perspective: It is essential to assign responsibilities among different economic operators, including manufacturers, importers, authorised representatives, or fulfilment service providers, to ensure product safety requirements are met. Additionally, an EU-based Responsible Person is required. Besides, when selling products online (distance selling), the offer must clearly indicate the manufacturer’s name, registered trade name or trademark, postal and electronic addresses, product images, product types, and any other product identifiers (such as barcodes), as well as warning or safety information.
Product safety perspective: This entails conducting a thorough risk assessment to identify potential hazards associated with the product.
Following this, manufacturers must validate product safety through appropriate product testing methods. The risk assessment should include examining the use and functionality of the product, which will assist in determining the safety measures necessary to mitigate any identified risks.
Technical documentation is also a critical component in GPSR compliance. It must detail the description of the product and its essential characteristics necessary to assess its safety, the analysis of possible risks and the technical means adopted to mitigate or eliminate the risks should also be included. Where the product complies with European standards or other elements applied to meet the general safety requirement laid down in this Regulation, the list of the relevant European standards or the other elements should also be indicated. This information is vital for regulatory compliance and should be retained for a minimum of ten years following the product's placement on the market.
Furthermore, GPSR outlines enhanced product labelling requirements, ensuring all necessary information is conveyed to consumers. Labels must include clear identification of the product and the manufacturer (including product type, batch, or serial number, manufacturer’s name, registered trade name, or registered trade mark, manufacturer’s postal and electronic address), any warnings and age suitability for children if applicable.
What are the consequences of GPSR non-compliance?
Non-compliance with the GPSR can lead to severe consequences, including:
- Product recalls: Non-compliant products may need to be removed from the market, which could be costly and damaging to your business’s reputation.
- Fines and penalties: Market surveillance authorities can impose financial sanctions on businesses that fail to comply with the regulation.
- Loss of consumer trust: Failing to ensure product safety can result in negative publicity and a loss of customer confidence.
- Legal actions: In serious cases, legal action may be taken against businesses that fail to adhere to the safety standards.
How can the Eurofins Softlines & Hardlines network help achieve GPSR compliance?
As the General Product Safety Regulation (GPSR) becomes fully operational, it is crucial for businesses to understand their responsibilities under this regulation. By complying with GPSR requirements, you protect your customers, avoid costly penalties, and ensure that your products remain competitive in the EU market.
Eurofins Softlines & Hardlines provides comprehensive solutions for General Product Safety Regulation (GPSR) compliance, including product testing, risk assessment, technical documentation preparation, labelling review, and CE certification for specific types of products, such as toys.
We assist businesses in navigating the complexities of product safety requirements.
Contact us for GPSR compliance today!