General Product Safety Regulation (GPSR)
The European Union (EU) is one of the world’s largest and most regulated markets, offering vast opportunities for businesses and eCommerce sellers worldwide. However, to successfully enter and compete in the European market, businesses must comply with stringent EU product safety legal frameworks, such as the General Product Safety Regulation (GPSR). The GPSR ensures that all consumer products—whether imported, locally manufactured, or sold online—meet the highest safety standards to protect EU consumers.
For Indian exporters and eCommerce sellers, understanding and adhering to GPSR requirements is essential to ensure European market access, avoid penalties, and build consumer trust. At IndiaFilings, we provide expert guidance and support to help businesses and online sellers navigate the complexities of EU product regulations and achieve seamless compliance with GPSR.
Contact us for a consultation and take the first step toward ensuring your business is GPSR-compliant and ready for the EU market.
What is the General Product Safety Regulation (GPSR)?
The General Product Safety Regulation (GPSR) is a new set of rules in the European Union designed to keep consumer products safe. Starting on 13 December 2024, it will replace older rules (the General Product Safety Directive (GPSD) and the Food Imitating Product Directive) to make sure safety standards are modern and fit for today’s digitalisation of our economies, especially with how technology and online shopping have changed the way we buy products.
The GPSR ensures that all products sold to consumers in the EU are safe to use. It also sets specific responsibilities for businesses to follow these EU safety rules. It applies to all non-food products, no matter how they are sold—whether in stores or online. If other European Union laws don’t cover any risks, the General Product Safety Regulation acts as a backup to make sure consumers are always protected.
Goals of the GPSR
- Make all products safe: Ensure that all consumer products, even those using new technology, are safe for EU consumers.
- Tackle online sales risks: Address problems caused by the rise of online shopping, especially from online marketplaces.
- Better enforcement: Strengthen how the rules are enforced and improve market checks for unsafe products.
- Improve product recalls: Make it easier and more effective to recall dangerous products from EU consumers.
Key Provisions and Changes under the GPSR
The General Product Safety Regulation (GPSR) introduces several significant changes. Below are some of the key provisions and changes:
Mandatory Risk Assessment
Under the GPSR, businesses must carry out detailed safety assessments for their consumer products before they are sold. This includes identifying potential risks, especially from new technologies like AI and IoT. The results of these assessments must be documented and available for inspection by authorities.
Better Traceability and Digital Product Passport
GPSR requires businesses to keep records that allow consumer products to be traced throughout the supply chain. A new "digital product passport" will store safety information and make tracking easier.
Requirements for Online Marketplaces
GPSR places new responsibilities on online marketplaces, ensuring that online products are as safe as those sold in physical stores. Marketplaces must verify that the products listed meet GPSR safety standards and cooperate with authorities if any safety issues arise.
What Products Come Under the Scope of the GPSR?
The General Product Safety Regulation (GPSR) applies to a broad range of consumer products available in the EU, ensuring consumer safety across various categories.
Products Covered:
- New, used, repaired, or reconditioned products:
- Any product offered in the European Union for distribution, consumption, or use, whether sold for free or for payment.
- Products not already covered by specific EU safety legislation, except for risks and aspects explicitly addressed by such laws.
Sales through all channels:
Includes products sold online, in physical stores, or via any other sales channel.
Products Excluded:
The GPSR does not apply to the following products:
- Medicinal products for human or veterinary use.
- Food and animal feed.
- Living plants and animals, genetically modified organisms (GMOs), or microorganisms in contained use.
- Animal-derived products and by-products.
- Plant protection products.
- Transport equipment operated by service providers.
- Aircraft with low safety risks in design, production, maintenance, and operation.
- Antiques.
- Products marked for repair or reconditioning before use.
Who Must Comply with the General Product Safety Regulation (GPSR)?
The General Product Safety Regulation (GPSR) applies to several groups involved in placing consumer products in the European Union market. These include:
- Manufacturers: They are responsible for ensuring that products are safe by design and meet the required safety standards. They must assess risks, keep technical records, and take immediate action if a product is found to be dangerous.
- Importers: Importers must ensure that products they bring into the EU meet safety requirements before being sold. They are also responsible for providing clear safety instructions and contact details on the products.
- Distributors: Distributors, such as retailers, must ensure that the products they sell comply with safety regulations. If they find unsafe products, they are responsible for not selling them and reporting them to the relevant authorities.
- Online Marketplaces: Online platforms that allow third-party sellers to list products must comply with the General Product Safety Regulation. They are required to ensure that consumer products listed on their platform meet safety standards, provide clear contact details, and act quickly in case of recalls or safety issues.
- Authorised Representatives: Manufacturers can appoint authorised representatives to handle their product safety responsibilities, especially when the manufacturer is located outside the EU.
Responsibilities of Economic Operators in the EU
As mentioned, The General Product Safety Regulation (GPSR) requires that every product sold in the EU must have a responsible "economic operator" in the EU. This operator could be the manufacturer, importer, authorised representative, or fulfilment service provider. They are responsible for making sure the product is safe for consumers.
Responsibilities of Manufacturers Under GPSR
- Product Safety: Manufacturers must design products with safety in mind, ensuring they are safe for use and meet all necessary safety requirements.
- Risk Analysis and Documentation: Manufacturers must conduct internal product risk assessments. They must maintain technical documentation, including:
- A detailed description of the product.
- Information is required to assess its safety.
- It adheres to any relevant European safety standards.
- Immediate Action: If a manufacturer identifies that a product is unsafe or poses a risk to consumers, they must quickly inform EU consumers and relevant national authorities about the danger.
- Accident Reporting: In the event of an accident involving their product, manufacturers must immediately report the incident to the appropriate EU authorities.
Main Responsibilities of Importers
- Product Compliance: Importers must ensure the consumer products meet the general safety requirements before being sold in the EU.
- Clear Information: They must ensure the product comes with clear safety instructions and their contact details.
- Transport and Storage: Importers are responsible for the safety of the products while they are being transported or stored.
- Reporting Dangerous Products: If they believe a product is dangerous, they must inform manufacturers and European market authorities.
Main Responsibilities of Distributors
- Compliance Check: Distributors must ensure that manufacturers and importers follow safety rules. If a product doesn’t meet safety standards, they must refuse to sell it.
- Reporting Dangerous Products: Distributors must report dangerous products to manufacturers, importers, and market authorities.
General Responsibilities of Economic Operators
- Safety Processes: Economic operators must set up internal safety processes to comply with the regulation.
- Cooperation with Authorities: They must work with authorities to remove unsafe products from the European market.
- Providing Information: If requested, they must provide information on products for up to 10 years and maintain traceability for 6 years.
- Accident Reporting: They must inform authorities about accidents caused by a product.
- Recalls and Warnings: They must directly inform EU consumers about product recalls and safety warnings, offering remedies like product repair, replacement, or refunds.
- Distance Sales: For online sales, they must provide clear product information, including safety details.
Responsibilities of Online Marketplaces
- Safety Contact Points: Online marketplaces must provide two contact points—one for market authorities and one for the public to report safety concerns.
- Safety Gate Registration: They must register on the Safety Gate portal and follow safety processes.
- Product Safety Checks: Marketplaces must make sure consumer products have all necessary safety and traceability information before they are listed for sale.
- Random Checks: They need to randomly check if products sold on their platform are safe, using public databases like Safety Gate.
- Recall Communication: In case of a recall, they must contact all consumers who bought the product and provide the information on their website.
- Cooperation with Authorities: If there's a recall or accident, they must inform the relevant economic operator and cooperate with authorities.
Key Obligations for Online Sales
When selling products online—whether through their own website or via online marketplaces—eCommerce operators must ensure that the following information is provided:
Manufacturer Information:
- Name, registered trade name, or trademark of the manufacturer.
- Postal and email addresses where they can be contacted.
For Non-EU Manufacturers:
- The name, postal, and email address of the Responsible Person designated within the EU. (Note: The Responsible Person is a designated contact for non-EU manufacturers who will be held accountable for product safety within the EU market)
In short, everyone involved in bringing a product to market in the EU—whether manufacturers, importers, distributors, or online platforms—has clear responsibilities to ensure product safety and act quickly if something goes wrong.
Safety Requirements for Products under the GPSR
Economic operators (businesses) must ensure that only safe products are placed on the market or made available to consumers. This is the general safety requirement of the regulation.
To assess the safety of a product, several factors must be considered, including:
- Product characteristics: This includes the design, technical features, composition, packaging, and instructions for use.
- Effect on other products: How the product may interact or affect other products when used together.
- Presentation and labelling: The product’s appearance, labelling, warnings, safety instructions, and any other information provided to consumers.
- Consumer categories: The safety needs of different types of consumers who may use the product.
- Appearance: Particular attention to products that may appeal to children or imitate food.
- Cybersecurity and functionalities: Products with evolving, learning, or predictive features must be assessed for potential risks.
Safe Products
Some products may be considered safe if they comply with relevant European standards published in the Official Journal of the European Union. Other factors that may support the safety assessment include:
- National and international standards
- Voluntary certification schemes
- Good-practice codes
- Reasonable consumer expectations
Information on Unsafe Products
- Dangerous products: If a product is considered dangerous in one EU Member State, it is also assumed to be dangerous in all other EU Member States.
- Product recalls: When a product is recalled, businesses must provide clear, detailed information to the public. Consumers must be offered an effective, free, and timely remedy.
- Safety information: Information about unsafe products should generally be made available through the Safety Gate portal.
Safety Gate Rapid Alert System and Safety Business Gateway
As mentioned, The EU Commission has set up two portals to help quickly share important safety information about products in the EU:
Safety Gate Portal
This portal is for the public and market surveillance authorities. It allows them to quickly access information about unsafe products in the EU, including warnings and recalls.
Safety Business Gateway
This portal is for economic operators (like manufacturers, importers, and distributors) and online marketplace providers. It helps them provide information to market surveillance authorities and consumers, as required by the General Product Safety Regulation. It ensures that relevant safety information is shared efficiently.
How to Ensure Your Business Meets GPSR Compliance?
To make your business GPSR (General Product Safety Regulation) compliant, you must implement a series of strategic actions to ensure your products meet the required safety standards set by the regulation. Here's a step-by-step guide on how to achieve compliance:
Conduct Thorough Risk Assessments
Businesses should carry out detailed risk assessments for all products, identifying potential hazards at every stage of the product lifecycle. These assessments must be well-documented, with clear responsibility assigned for product safety.
Strengthen Supply Chain Management
Ensure that all suppliers and manufacturers meet GPSR safety standards. Work closely with partners to confirm that products are compliant and that traceability systems are in place. Building strong, long-term relationships with trusted suppliers can help reduce risks.
Invest in Employee Training
Train employees, especially those in product design, quality control, and compliance roles, on GPSR requirements. Regular training sessions will keep staff updated on the latest regulations and help ensure proper implementation.
Use Existing Testing Data and Documentation
Review existing product testing data and documents to see how they can be used to meet General Product Safety Regulation requirements. Centralising this information can reduce duplication and make the compliance process more efficient.
Prepare for Market Surveillance and Audits
Given the stronger powers of market surveillance authorities, businesses should be ready for more frequent inspections and audits. Having a strong compliance program in place will help reduce the risk of non-compliance and ensure readiness for audits.
Consequences of Non-Compliance with GPSR
Non-compliance with the General Product Safety Regulation (GPSR) can lead to significant penalties for businesses. These penalties may include hefty fines, product recalls, or even bans on selling unsafe products in the EU market. In severe cases, manufacturers and distributors may face criminal charges. Additionally, businesses found in violation of GPSR requirements may suffer reputational damage, loss of consumer trust, and potential legal actions from regulatory authorities.
GPSR Obligations for Indian Businesses Selling to the EU
Indian exporters and eCommerce businesses selling products in the European Union (EU) must comply with the General Product Safety Regulation (GPSR) to ensure their products meet the EU’s stringent safety standards. The GPSR applies to all non-food products in the EU, whether manufactured within the EU or imported, ensuring that they are safe for consumers.
By adhering to the GPSR, Indian businesses can ensure their products meet the necessary safety requirements and maintain access to the highly regulated EU market.
Ensure Your Business is GPSR Compliant with IndiaFilings!
IndiaFilings can assist businesses in navigating the complexities of GPSR compliance by offering expert guidance and resources. Whether you are an Indian exporter or an e-commerce operator looking to sell in the EU, IndiaFilings provides the necessary tools and expertise to ensure that your products meet all safety standards and regulatory requirements. Whether you’re new to the EU market or need assistance with ongoing compliance, we’re here to help.
Get started today! Reach out to our team for expert assistance with GPSR compliance and ensure your products are ready for the EU market.