General Product Safety Regulation
Learn how the General Product Safety Regulation (EU) 2023/988 impacts your business, including key steps for regulatory compliance, risk assessment, and documentation to ensure product safety in the EU.
Table of Contents
What is Regulation (EU) 2023/988?
Objectives of the General Product Safety Regulation
Scope of Application: Affected Products
How It Will Affect Your Business
Regulatory Compliance in the EU: Key Steps
Required Documentation for Compliance
Safety Gate Alert System
Risk Assessment: A Fundamental Pillar
Conclusion: Preparing Your Business for the Future
What is Regulation (EU) 2023/988?
Regulation (EU) 2023/988, known as the General Product Safety Regulation, is a regulation that strengthens the safety of products marketed within the European Union. It was published in 2023, replacing the former Directive 2001/95/EC, with the aim of adapting legislation to modern challenges, such as e-commerce and the growing complexity of supply chains. It shall apply from 13 December 2024.
This regulation sets stricter requirements for manufacturers, importers, and distributors, ensuring that all products, regardless of origin, are safe for European consumers. Additionally, it introduces new obligations for online platforms and Marketplaces, which now bear greater responsibility for verifying the safety of products sold through their sites.
Objectives of the General Product Safety Regulation
The primary objective of Regulation (EU) 2023/988 is to ensure that all products available in the EU market are safe. To achieve this, the regulation:
Strengthens obligations for all actors in the supply chain, from manufacturers to distributors.
Introduces new obligations for online platforms, ensuring the safety of products sold through e-commerce.
Facilitates the swift removal of dangerous products from the market.
Increases transparency in the supply chain, promoting greater traceability of products.
Establishes stricter penalties for those who fail to comply with safety standards.
Scope of Application: Affected Products
The General Product Safety Regulation (EU) 2023/988 applies to a wide range of products, including those that were previously not covered by specific legislation. Below are some of the main products not covered by other specific legislation to which this regulation applies:
Outdoor furniture (chairs, tables, etc.).
Childcare articles (cribs, car seats, educational toys, etc.).
Fixed training equipment (weight benches, treadmills, etc.).
Children's furniture (cribs, changing tables, high chairs, etc.).
Textiles and clothing (baby clothes, sportswear, etc.).
DIY tools and equipment (drills, saws, etc.).
Kitchenware (graters, choppers, etc.).
Furniture and decorative items (folding beds, blinds, etc.).
Bicycles, scooters, skates, and other cycles.
Flotation aids for swimming instruction.
Floating leisure articles for use on and in water (air mattresses, etc.).
Barbecues and lighters.
Any product that may pose a risk to consumer safety is subject to this regulation, encompassing everything from everyday consumer goods to more specialized products.
How It Will Affect Your Business
The impact of Regulation (EU) 2023/988 on your business will depend on your role in the supply chain and the type of products you offer. Here are some of the most significant effects:
Increased responsibility for manufacturers and importers: You must ensure that all your products meet safety standards before they reach the market.
Additional obligations for distributors and retailers: You will need to verify the compliance of products before sale and collaborate in the removal of dangerous products.
Online platforms under scrutiny: If you operate an online marketplace, you will need to implement stricter control systems to ensure that the products sold on your platform are safe.
Additional costs: Compliance processes, including product testing and control measures, may increase operational costs.
Regulatory Compliance in the EU: Key Steps
To comply with Regulation (EU) 2023/988, it is crucial to follow these key steps:
Risk assessment: Conduct a thorough assessment of the risks associated with your products.
Product testing: Ensure that all products undergo rigorous testing before commercialization.
Documentation: Keep detailed records of product compliance, including tests and certifications.
Swift removal: Establish an action plan for the prompt removal of dangerous products if necessary.
Collaboration with authorities: Work closely with market surveillance authorities to ensure regulatory compliance.
Required Documentation for Compliance
Compliance with Regulation (EU) 2023/988 requires robust and detailed documentation. This documentation is essential to demonstrate product compliance and ensure that they can be safely marketed in the EU. Below is the key documentation you should consider:
Declaration of conformity: A document in which the manufacturer declares that the product meets all applicable regulatory requirements.
Risk assessment: Detailed records of risk assessments conducted to identify and mitigate hazards associated with products.
Test results and certifications: Documentation of tests conducted to verify product safety, including lab tests and compliance analyses.
User manual and labeling: Clear instructions for the safe use of the product, as well as labeling that meets safety requirements.
Supplier records: Detailed information about suppliers and subcontractors involved in the manufacturing and distribution of the product to ensure traceability.
Action plan for removal: A documented procedure for the rapid and effective removal of dangerous products from the market if necessary.
It is essential that this documentation is available at all times and updated periodically to reflect any changes in the design or manufacturing of the product.
Safety Gate Alert System
The Safety Gate is the EU's rapid alert system for non-food dangerous products. It is a crucial component of the EU product safety framework, allowing for the rapid dissemination of information about products that pose a risk to consumer health and safety.
How the Safety Gate works:
Rapid notification: When an authority in a Member State detects a dangerous product, a notification is issued through the Safety Gate to alert all EU countries.
Corrective actions: The companies involved must take immediate action, such as removing the product from the market, issuing warnings to consumers, or revising advertising campaigns.
Public information: Consumers and businesses can access information published in the Safety Gate to stay informed about dangerous products on the market.
The Safety Gate system is a vital tool for companies seeking to maintain compliance and protect consumers. Through this system, you can monitor alerts and ensure that your products are not subject to any notification that may require corrective action.
Access to the Safety Gate: European Commission Safety Gate Portal
Risk Assessment: A Fundamental Pillar
Risk assessment is a central component of compliance with Regulation (EU) 2023/988. Here's why it's so important:
Hazard identification: Evaluate all possible hazards a product may present throughout its lifecycle, from manufacturing to consumer use.
Likelihood and severity: Analyze the likelihood of these hazards occurring and the severity of their possible consequences.
Mitigation measures: Implement measures to mitigate the identified risks, such as product design improvements or clearer user instructions.
Ongoing documentation: Maintain continuous records of risk assessments, which may be requested by authorities at any time.
Conclusion: Preparing Your Business for the Future
Regulation (EU) 2023/988 on General Product Safety is a significant change that affects all businesses marketing products in the European Union. While its implementation may seem challenging, it is an opportunity to improve your products' safety, strengthen consumer trust, and avoid costly penalties.
Adequately preparing for this new regulation is not only a legal obligation but also a strategy to differentiate yourself in an increasingly competitive market. From risk assessment to collaboration with online platforms, each step toward regulatory compliance brings you closer to a safer, more reliable, and successful business.
Relevant Links:
Case Studies and Practical Examples
A toy manufacturer discovers, thanks to their trusted consultancy, that the eyes of several of their plush dolls are small parts that could pose a choking hazard. This meant that their dolls did not comply with the new General Product Safety Regulation. They were able to make a design change by switching to embroidered eyes, thus avoiding the removal of their products from the market.
A marketplace found that several sellers were offering products that did not comply with the General Product Safety Regulation. The platform implemented an automated control system that verifies the content of the products' declaration of conformity before publication. As a result, they discovered that several products were not applying the applicable harmonized standards.
Frequently asked questions (FAQs)
What products does Regulation (EU) 2023/988 apply to?
It applies to all products marketed in the EU that may pose a risk to consumer safety, including electronics, toys, textiles, among others.
How does this regulation affect small businesses?
Small businesses must ensure that their products comply with the new requirements, which may involve additional costs for testing and risk assessments but also offers the opportunity to stand out for their commitment to safety.
What does risk assessment involve?
Risk assessment involves identifying and analyzing the hazards associated with a product, the likelihood of occurrence, and the severity of consequences, to implement measures that mitigate these risks.
What penalties apply in case of non-compliance?
The regulation provides for severe penalties, including significant fines and the removal of products from the market, for those who do not comply with safety requirements.
What responsibilities do online platforms have?
Online platforms must verify the compliance of products sold through their sites, collaborate in the removal of dangerous products, and ensure that products meet safety standards.
How can you prepare for compliance with the regulation?
Conduct a thorough risk assessment, ensure all your products undergo safety testing, maintain detailed documentation, and closely collaborate with market surveillance authorities.