Product Safety Regulation (ProdSG) 2023/988

The General Product Safety Regulation (EU) 2023/988 marks a milestone for the European single market. This regulation brings with it far-reaching changes for all economic operators and places new demands on product safety. Particularly noteworthy are the extended obligations for online marketplaces and the increased requirements for product traceability. The EU Product Safety Regulation aims to ensure a consistent level of protection for consumers while creating a clear framework for businesses.

An overview of the important changes in the Product Safety Regulation

1. Expanded definition of products: The regulation now also covers digital products and services, which means that companies offering such products are also subject to the new safety requirements .
2. Increased obligations for online marketplaces: Providers of online marketplaces have extended obligations, in particular with regard to monitoring the products they offer. They must ensure that the products sold through their platforms meet the safety requirements and may suspend the provision of their services if the regulation is repeatedly violated ,.
3. Obligation to cooperate with market surveillance authorities: The regulation stipulates that online marketplace providers must actively cooperate with market surveillance authorities to identify and mitigate risks. This includes providing assistance with traceability and identifying dangerous products .
4. Risk management and internal procedures: Companies are encouraged to establish internal compliance procedures to ensure that they can fulfill their obligations effectively and in a timely manner. This also includes responding to dangerous products in a timely manner .
5. Obligation to report risks: Companies will have to provide information on emerging risks and relevant market developments to market surveillance authorities and the Commission to ensure product safety and detect violations of the regulation.
6. Practical support for SMEs: The Commission will provide specific guidance and support for small and medium-sized enterprises (SMEs) to help them understand and implement the new requirements. This could include training and advice .
7. Increased focus on traceability: The requirements for product traceability have been tightened to ensure that companies are able to quickly identify dangerous products and take appropriate action, such as recalls .

The scope of the new regulation now extends significantly further than before. Key points include the harmonization of safety standards and the integration of digital products into the regulatory area. Significant changes concern the duties to cooperate with authorities and the introduction of stricter control mechanisms. Companies must adapt their internal processes accordingly and implement new responsibilities. These adjustments require a systematic approach and affect all aspects of product safety.

Expanded definition of product safety

The Product Safety Regulation introduces a comprehensive redesign of the product concept. For the first time, digital products and services are also subject to the safety requirements. This expansion is a response to the increasing digitalization of the market and closes previous regulatory gaps. Particular importance is attached to the security of software and networked devices. Companies must now also take comprehensive security precautions and carry out risk assessments for digital offerings.

New obligations for online marketplaces

Operators of online marketplaces are facing increased obligations. Central to this are the tightened monitoring obligations for products offered and their safety compliance. Platform operators must introduce effective systems for product control and react quickly to violations. The suspension of services in the event of repeated violations of the regulation is one of the new sanction options. Particular attention is paid to the verification of product information and safety certificates before listing new offers.

Basic responsibilities for product safety

The new EU General Product Safety Regulation defines precise responsibilities for all actors in the supply chain. Primary responsibility lies with the manufacturers, but importers and distributors also have specific obligations. Core elements are continuous product monitoring and the implementation of quality assurance systems. Companies must demonstrably ensure that their products meet safety requirements throughout their entire lifespan.

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Obligations of manufacturers and importers

Manufacturers bear the main responsibility for product safety and must carry out comprehensive conformity assessments. The documentation of all safety-related aspects and the performance of regular risk assessments are among the core obligations. Importers, for their part, must verify and ensure compliance with all safety requirements. The retention of technical documentation and the provision of safety information also fall within their area of responsibility.

Distributor obligations and market responsibility

Distributors must actively contribute to ensuring product safety. This includes checking declarations of conformity and labeling, as well as safe storage and transport. Particular care must be taken when passing on product information to consumers. Market responsibility also includes the obligation to take immediate corrective action in the event of safety defects and to cooperate with authorities.

Risk assessment and harmonization in accordance with the EU General Product Safety Regulation

The harmonized risk assessment is at the heart of the new General Product Safety Regulation. Member states must apply uniform assessment criteria in order to avoid fragmentation. The standardized procedures enable a more reliable assessment of product risks across national borders. This harmonization creates legal certainty for companies while ensuring a high level of consumer protection in all EU countries.

Uniform assessment criteria

The standardized assessment methods are based on scientifically sound criteria for risk assessment. Core elements include the systematic recording of potential hazards and the assessment of the probability of occurrence and extent of damage. The methodology takes into account different user groups and usage scenarios. Particular attention is paid to vulnerable consumer groups such as children or the elderly.

Preventive measures to minimize risk

Preventive measures to minimize risk are becoming increasingly important. Companies must implement proactive systems for the early detection of potential safety risks. The continuous monitoring of products in the market and the regular updating of risk assessments are mandatory. It is essential to integrate preventive measures into all phases of the product life cycle, from development to market observation.

Cooperation with market surveillance authorities

The new regulation significantly intensifies cooperation between companies and market surveillance authorities. Economic operators must actively communicate with the relevant authorities and exchange information on safety risks. The structured dialog enables faster responses to identified hazards. Official inquiries must be given priority and require immediate action to minimize risk.

Reporting requirements and information sharing

The new reporting requirements necessitate a systematic exchange of information between companies and authorities. Safety-related findings must be passed on immediately to enable rapid responses. The flow of information includes detailed product data, risk assessments and measures already taken. Companies must establish internal processes to ensure timely compliance with these reporting requirements. The exchange takes place via standardized communication channels and defined reporting formats.

Joint safety measures

Coordinated action between economic operators and authorities is becoming increasingly important. Cooperation ranges from joint market surveillance actions to coordinated recalls. Authorities and companies develop joint strategies to minimize risk and implement them in a coordinated manner. The pooling of expertise and resources enables more effective measures to protect consumers.

Product traceability

The Product Safety Regulation places increased demands on traceability. Companies must implement seamless documentation systems that make the entire product path traceable. The tightened requirements affect all stages of the supply chain and require new technical solutions. Particular importance is attached to the rapid identification and localization of products in the event of safety-related incidents.

Documentation requirements

The expanded documentation requirements cover all safety-related aspects of the product life cycle. Companies must keep detailed records of manufacturing, transportation and distribution. The documentation must also include information about suppliers, customers and the controls that have been carried out. Particular emphasis is placed on the traceability of changes and updates to product specifications.

Technical requirements

The technical implementation of traceability requires modern systems for data collection and management. Companies must introduce and maintain reliable identification systems for their products. The implementation of digital tracking systems enables the rapid localization of products in the market. The linking of various data points along the supply chain, from production to the end user, is central. Technical solutions must meet the highest standards of data security.

Support for small and medium-sized enterprises (SMEs)

The EU General Product Safety Regulation takes particular account of the needs of small and medium-sized enterprises. Special support services are available to help with the practical implementation of the new requirements. The European Commission provides customized guides and advisory services. SMEs have access to expert knowledge and practical implementation tools to help them efficiently implement the requirements of the regulation.

Early warning systems and risk management

The Product Safety Regulation requires the establishment of effective early warning systems for risk identification. Companies must establish systematic processes for identifying and evaluating new safety risks. The early detection of potential hazards enables preventive measures to be taken before damage occurs. Risk management must cover all aspects of the product life cycle and be continuously updated.

Internal control mechanisms

The internal monitoring systems must include various levels of control and be regularly reviewed. Quality assurance processes and product controls form the basis of internal risk management. The documentation of control results and measures taken must be seamless. Employees require regular training in the correct implementation of control processes.

External reporting systems

Networking with external warning systems is becoming increasingly important. Companies must actively participate in existing reporting systems and exchange information. Integration into European warning systems enables rapid responses to identified hazards. Standardized reporting procedures ensure efficient communication between all parties involved.

Conclusion and outlook

The EU General Product Safety Regulation marks a decisive step towards improving product safety in the European single market. The new requirements demand significant adjustments on the part of companies. The increased harmonization and improved cooperation between all parties involved will create more safety for consumers in the long term. At the same time, clear framework conditions will create new opportunities for companies.

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