EU General Product Safety Regulation (2023/988 – GPSR) – Comprehensive Guide for Manufacturers
EU General Product Safety Regulation (2023/988 – GPSR) – Comprehensive Guide for Manufacturers
General Product Safety Regulation (GPSR), officially known as Regulation (EU) 2023/988, is the latest legislation introduced by the European Union to enhance consumer product safety. Adopted in May 2023, this regulation replaces the General Product Safety Directive (GPSD), which had been in force for over twenty years, introducing stricter and uniformly applied safety rules across all member states. The provisions of the GPSR came into effect on December 13, 2024, making compliance with the new rules mandatory for all economic operators, including manufacturers, importers, and online marketplace operators.This guide outlines the scope of the GPSR, its implementation timeline, and key obligations for manufacturers—such as the newly introduced requirement to appoint a “Responsible Person” and the responsibilities of digital marketplaces. Additionally, we highlight how Doruk Sistem can support businesses in complying with this new regulation through services such as technical file preparation, risk assessment, Responsible Person services, and product tracking systems. Designed to serve both local manufacturers operating in the EU market and companies exporting from Turkey to the EU, this guide aims to provide clear and practical insights into GPSR compliance.
What is the GPSR and Who Needs to Comply?
The GPSR is a broad EU regulation focusing on consumer product safety. In principle, it covers all products placed or made available on the EU market – whether new, used, second-hand, refurbished, or sold online – intended for consumers or likely to be used by consumers. This wide scope means virtually all consumer goods fall under GPSR unless they are explicitly regulated by other specific EU laws. Notable exceptions include products like medicinal drugs, foods, live plants and animals, certain motor vehicles or aircraft, antiques, and a few other categories that are governed by their own sectoral regulations. Aside from these exclusions, any business selling or distributing consumer products in the EU must comply with GPSR. This target audience includes EU-based manufacturers, importers bringing products from outside the EU, distributors, and online sellers or marketplace platforms.
Importantly, non-EU manufacturers (for example, companies in Turkey or other countries exporting to the EU) are also directly impacted. To continue offering products in the EU after December 2024, such companies must meet GPSR requirements via their EU trade partners or representatives. In summary, if you are a producer or seller of consumer goods destined for the EU market, GPSR is highly relevant to you.
When Does the GPSR Take Effect?
The new regulation, GPSR, was published in the Official Journal of the EU on May 23, 2023, and came into force on June 12, 2023. However, its actual implementation—meaning the requirement for products on the market to comply with the new rules—began on December 13, 2024. The approximately 18-month transition period allowed companies to complete their compliance preparations. After December 13, 2024, all relevant products in the EU market must comply with the GPSR requirements, as the previous regulation (GPSD) will be entirely repealed from that date onward.
Scope of Products and Key Changes under GPSR
Under the GPSR, consumer product safety is tightened and modernized to address today’s market realities. Some key changes and new requirements that manufacturers and sellers should be aware of include:
- Broader Product Coverage: The GPSR explicitly covers products sold online and offline, whether new or used. It closes gaps that might have existed for second-hand sales or online imports. All consumer products are in scope unless covered by dedicated EU legislation (e.g. food, pharmaceuticals, medical devices, etc. are exempt). Even products initially intended for professional use must comply if they later enter the consumer market.
- Stronger Pre-Market Risk Assessment: Manufacturers are now required to perform a rigorous internal risk analysis for their products before placing them on the market. This means evaluating all potential hazards a product might pose throughout its lifecycle and to different consumer groups (including children, the elderly, people with disabilities, etc.). The GPSR expands the factors to consider in a safety assessment – for example, it highlights risks from product interconnectivity, cybersecurity vulnerabilities, and even evolving technologies like AI in smart products. Manufacturers must ensure their product design and instructions mitigate any significant risks identified.
- Technical Documentation (“Technical File”): Alongside the risk assessment, manufacturers must prepare and maintain a technical documentation file demonstrating the product’s safety. Article 9 of GPSR requires technical docs (and relevant test reports) as evidence that a product is safe, to be ready before the product is placed on the market. This technical file should include details like product design and manufacture, standards applied, test results, risk analysis outcomes, and user instructions. GPSR mandates that technical documentation be kept up-to-date and retained for at least 10 years after the product is released. Authorities can request this file at any time to verify compliance. In short, even for products that were not subject to CE-marking or other specific directives, you now need a formal compliance dossier on hand.
- “Responsible Person” in the EU – Economic Operator Requirement: One of the most significant new obligations is that every product must have an identified responsible person or economic operator located in the EU who can be accountable for product safety. In practice, this means if you are a manufacturer based outside the EU, you must designate an EU-based entity to take on certain safety responsibilities for your product. This could be your importer, an authorized representative, a fulfillment service provider, or another qualified entity established in the EU. Without such a responsible economic operator in the Union, the product cannot be placed on the EU market. This rule extends a concept from the EU Market Surveillance Regulation 2019/1020 to all consumer products. The responsible person’s name and contact details must also be indicated (usually on the product or packaging, or in an accompanying document) so that authorities and consumers have a point of contact. For companies in Turkey, this means you may need to appoint an EU-based representative (and update labels/packaging to include their information) in order to continue selling into Europe.
- Enhanced Product Identification and Traceability: The GPSR introduces stricter traceability requirements. Manufacturers must ensure products bear a type, batch, serial, or model number for identification, and their name, registered trade name or trademark, and a contact address (including an email address) are provided with the product. This information should be visible on the product or its packaging. If the manufacturer is outside the EU, the product must also show the details of the EU responsible person or importer fulfilling this role. These measures make it easier to trace products back to their source and contact the right party if an issue arises. Additionally, the European Commission can introduce specialized digital traceability systems for certain products that pose serious risks – potentially requiring companies to collect and retain data (for example, via RFID or digital product passports) to track such products. Being prepared for traceability means having systems in place to mark and log product batches and to quickly retrieve distribution information if a recall is needed.
- Requirements for Online Sales & Marketplaces: Recognizing the huge growth of e-commerce, the GPSR places responsibilities on online marketplaces to police product safety on their platforms. Online marketplace providers (like Amazon, eBay, AliExpress, etc.) must ensure that product listings by third-party sellers include all the required safety information – such as the manufacturer’s name, address, contact email, product identifiers, and any applicable warnings in the appropriate language. Marketplaces are expected to design their interfaces to make it easy for sellers to provide and display this information. If sellers fail to provide the required details or repeatedly list non-compliant (unsafe) products, the marketplace must suspend their activities.
Online marketplaces also have new compliance and cooperation duties with regulators. They are required to cooperate with EU market surveillance authorities (MSAs), for instance by allowing authorities access to their websites and even permitting automated data scraping to identify dangerous products. If a marketplace is notified by authorities that a product is unsafe, they must act quickly – for example, removing or disabling access to the listing, warning consumers, and informing authorities – within two working days of receiving an order. Marketplaces must also register and interface with the EU’s Safety Gate/RAPEX alert system for dangerous products, so they can receive and relay warnings about unsafe items. Furthermore, they need to provide a single point of contact for consumers and regulators regarding product safety inquiries.
These requirements mean that online sellers will face greater scrutiny. Marketplaces will likely demand compliance documentation (test reports, technical files, proof of EU responsible person, etc.) from sellers more frequently. In practical terms, if you sell through online platforms into Europe, you should be prepared for stricter checks – Amazon and other big players have already begun verifying product safety compliance and this will intensify under GPSR.
- Improved Incident Reporting and Recall Effectiveness: The GPSR aims to make product recalls more efficient and consumer-friendly across the EU. Manufacturers are now required to set up effective communication channels for consumer feedback and complaints, such as a telephone hotline, email address, or website form for reporting safety issues. These channels should be public and accessible (including to users with disabilities) and manufacturers must actively monitor and investigate any safety problems reported. If a manufacturer becomes aware of a product hazard – whether through its own investigations, consumer complaints, or other sources – it must promptly take corrective actions, which could include issuing warnings or initiating a product recall. In such cases, the manufacturer also must inform the market surveillance authorities in all EU countries where the product was sold via the EU “Safety Business Gateway” portal. This is essentially a requirement to notify authorities of serious risks or incidents (such as accidents caused by the product) in a timely manner. The GPSR even mandates that manufacturers report any serious accidents linked to their products on the Safety Business Gateway, so regulators have a database of incidents.
When a recall is necessary, the GPSR sets standards on how it should be conducted. Notifications to consumers should be in plain language and in the local language of the customer, and the European Commission will provide a recall template to ensure consistency. Businesses (and online marketplaces, if relevant) must reach out to all affected consumers and offer remedies (repair, replacement, or refund) as appropriate. Overall, there is a big emphasis on being proactive and transparent with consumers about product safety issues.
- Other Noteworthy Provisions: The GPSR contains numerous detailed provisions; a few more examples include the incorporation of “safety net” rules for new technology (ensuring that even products with AI or software updates remain safe) and a ban on certain deceptive products. For instance, products that look like food but are not edible (such as toy or decorative items that resemble candy, which could cause choking) are explicitly classified as dangerous and prohibited from the EU market. The regulation also boosts the powers of national authorities for market surveillance, enabling them to impose fines or remove products more easily when safety rules are breached.
In summary, the GPSR significantly raises the bar for product safety compliance. Manufacturers must adopt a more systematic approach: conducting thorough risk assessments, documenting safety measures, keeping channels open for consumer feedback, and being ready to act quickly if something goes wrong. Meanwhile, every product sold to EU consumers needs a responsible party in the EU to be accountable for these duties.
Doruksistem’s GPSR Compliance Services – How We Can Help
Achieving compliance with the new GPSR can be challenging, especially for manufacturers outside the EU or those not previously subject to strict product-specific regulations. Doruksistem is here to guide and support producers through this transition. We offer a suite of GPSR compliance services tailored for both EU and Turkish manufacturers, ensuring that your products meet all requirements by the time the regulation is in force.
Our key services include:
- Technical File Preparation: Doruksistem’s experts assist you in preparing the complete technical documentation for your products as required by GPSR. We help gather and organize all necessary information – product specifications, design drawings, safety features, test reports, standards compliance, risk assessment reports, and user manuals – into a comprehensive technical file. This documentation is your evidence that the product is safe and complies with EU rules. We ensure your technical file is robust, well-structured, and ready to present to EU authorities or marketplace requests at a moment’s notice. We also advise on maintaining and updating these files for the 10-year period mandated by the regulation.
- Risk Assessment & Safety Compliance Review: Conducting a proper risk assessment is at the heart of GPSR. Our team will perform or guide you through a systematic risk analysis of your product, identifying potential hazards (from design, materials, usage, misuse, cybersecurity issues, etc.) and evaluating the risks to consumer groups. We then help you implement risk mitigation measures and safety improvements as needed. This service not only helps fulfill your pre-market risk analysis obligation, but also improves your overall product safety, reducing the chance of future incidents or recalls. Doruksistem stays up-to-date with the latest safety standards and “state of the art” requirements, so we can benchmark your product against the applicable harmonized standards or best practices to ensure compliance.
- “Responsible Person” (EU Authorized Representative) Service: For manufacturers based in Turkey or outside Europe, Doruksistem offers a Responsible Person service to satisfy the GPSR’s requirement of having an EU-based economic operator responsible for your product. Through our network and partners in the EU, we can act as your product’s Authorized Representative in the EU, serving as the official point of contact for product safety matters. This means we will handle tasks such as registering as the Responsible Person, providing our EU address on your product labels, holding your technical documentation available for EU authorities, and cooperating with market surveillance officials on your behalf. By appointing Doruksistem as your GPSR Responsible Person, you ensure that your product has a legitimate EU presence, allowing you to continue selling in the EU market without disruption. We take on the burden of liaising with regulators and fulfilling the obligations set out in Article 4(3) of the Market Surveillance Regulation and Article 16 of the GPSR – giving you peace of mind that there is always someone accountable in the EU for your product’s compliance.
- Product Traceability & Tracking Systems: Compliance is not just about paperwork – it’s also about having the right systems in place. Doruksistem helps companies implement traceability systems to track products through the supply chain. We can advise on batch numbering systems, database solutions to log product distribution, and integration with tools like the EU’s Safety Gate portal. Especially if the European Commission designates your product category for enhanced traceability, we will help set up the data collection and retention mechanisms needed. Additionally, we offer solutions for incident tracking and reporting – for example, setting up internal databases to record customer complaints or product incidents, which GPSR requires you to keep and review. By improving your traceability and record-keeping, you’ll be able to respond faster to any safety issue and carry out efficient recalls if ever needed.
- Consultancy on Online Marketplace Compliance: If you sell products via e-commerce or online marketplaces, Doruksistem can help ensure you meet the new platform requirements. We provide guidance on how to present the required product information in online listings (so that details like the manufacturer’s identity, contact info, and safety warnings are clearly shown). Our team will also help you prepare the documentation that marketplaces may request (such as test reports, declarations of conformity, etc.) so you won’t be caught off guard by compliance checks. In short, we make sure that your products won’t be taken down or blocked from online sale due to GPSR non-compliance.
- Training and Ongoing Support: Doruksistem believes in empowering manufacturers with knowledge. We offer training sessions and workshops for your compliance and quality teams on the GPSR – covering practical steps to meet the regulation’s requirements. Moreover, our consultancy is an ongoing partnership: we monitor updates, guidance documents from the European Commission, and evolving best practices related to product safety. As the GPSR era begins, we will keep you informed of any new developments (such as the official recall template or any standardization mandates) and help you continuously improve your compliance processes.
By leveraging Doruksistem’s services, manufacturers can turn GPSR compliance from a daunting challenge into a manageable process and even a competitive advantage. Compliance is not just about avoiding penalties – it’s about demonstrating to your customers that safety is your top priority. With our support, you can confidently market your products in the EU as fully compliant and safe, thereby protecting your brand reputation and building consumer trust.
Conclusion: Be Ready for GPSR – We’re Here to Assist
The EU’s new General Product Safety Regulation (2023/988) marks a new era in consumer product safety, raising the standards for everyone from product design labs to online marketplaces. Starting 13 December 2024, all companies selling consumer goods into Europe must adhere to this regulation’s stringent requirements. For manufacturers, this means now is the time to update your compliance strategies: ensure you have conducted thorough risk assessments, compiled technical files, appointed your EU Responsible Person, and set up the necessary channels for traceability and consumer communication. Non-compliance is not an option – without meeting these obligations, products risk being withdrawn from the EU market or facing other enforcement actions.
The good news is you don’t have to navigate these changes alone. Doruksistem is committed to guiding manufacturers in Turkey, the EU, and beyond through GPSR compliance. We have the expertise in EU regulations and a proven track record in product safety consulting to help your business adapt smoothly. From document preparation to acting as your local representative, we provide end-to-end solutions so you can focus on innovation and production, while we handle the regulatory intricacies.
Don’t wait until the last minute. Get ahead of the curve and turn compliance into a competitive edge. If you have questions about how the GPSR affects your specific products or want to learn how Doruksistem can tailor a compliance plan for you, reach out to us today. Contact Doruksistem for a free consultation on GPSR compliance and let our team help ensure your products are safe, compliant, and primed for success in the EU market.
Ready to achieve GPSR compliance? Contact Doruksistem now for expert guidance and start your journey towards hassle-free product safety compliance in the EU. We’re here to help you every step of the way – from now through December 2024 and beyond. Let’s make your products not only compliant, but leaders in safety and quality.