TOPICS·CONSUMER PROTECTION

EU General Product Safety Regulation

Regulation (EU) 2023/988 -- modernising EU product safety rules with new obligations for online marketplaces, strengthened recall procedures, and enhanced Safety Gate alerts.

EUAPPLICABLEIn force since 29 Jun 2023Applicable since 13 Dec 202435 regulations tracked
THE ESSENTIALS

Every consumer product sold in the European Union must be safe. That is the core principle behind the General Product Safety Regulation, which took full effect on 13 December 2024. It applies to anything a consumer can buy -- from furniture and clothing to kitchen gadgets and children's toys -- unless the product is already fully covered by its own EU safety law (like medical devices or food). If you make, import, distribute, or sell consumer products to people in Europe, this regulation sets the rules you must follow.

The biggest change from the old rules is that online marketplaces are now directly responsible for product safety on their platforms. They must verify seller identity, display safety information on product listings, monitor Safety Gate alerts for dangerous products, and notify customers directly when something they bought is recalled. Products sold online from outside the EU must have a responsible person established within the Union -- closing a longstanding gap where no one was accountable when things went wrong.

The regulation also requires that every product can be traced back to its maker. Manufacturers must put their name, postal address, and an electronic contact (like an email or website) on the product itself. If a safety problem is discovered after sale, the company must act immediately: notify authorities, recall the product if needed, and contact affected consumers directly. Consumers must be offered a real remedy -- repair, replacement, or refund -- at no cost.

This is not a directive that each country interprets differently. It is a regulation that applies identically in all 27 Member States. One set of rules, one standard, no exceptions. Companies that relied on favourable national readings of the old directive no longer have that option.

IN A NUTSHELL
WHAT
Directly applicable EU regulation ensuring all consumer products on the market are safe. Modernised rules for online sales, marketplace accountability, and digital product risks. Replaces the 2001 General Product Safety Directive.
WHO
Every economic operator in the supply chain: manufacturers, importers, distributors, fulfilment service providers, and online marketplaces selling consumer products to EU consumers.
WHEN
Adopted May 2023. Published in Official Journal June 2023. In force since 29 June 2023. Applicable since 13 December 2024, replacing the General Product Safety Directive (2001/95/EC).
PENALTY
Set by Member States. Includes product recalls, sales bans, market withdrawal, product destruction, and fines. Online marketplaces must remove unsafe products within 2 working days of notification.

The explosive growth of e-commerce fundamentally changed how consumers buy products. By the early 2020s, over 70% of EU consumers regularly purchased goods online, often from sellers established outside the European Union. The 2001 General Product Safety Directive was designed for a pre-digital market. It relied on national transposition, had no specific provisions for online marketplaces, and lacked effective tools for removing dangerous products sold through digital channels.

GPSR closes these gaps. As a regulation -- not a directive -- it applies directly and uniformly across all 27 Member States, eliminating the patchwork of national implementations that allowed inconsistent enforcement. For the first time, online marketplaces are named as obligated parties with specific duties: verifying sellers, displaying safety information on product listings, processing Safety Gate alerts, and directly notifying consumers about recalled products purchased through their platforms.

The regulation also modernises the concept of product safety itself. Products with digital elements, AI capabilities, or cybersecurity vulnerabilities can now be addressed under GPSR. A product that was safe when sold may become unsafe due to a software update or newly discovered vulnerability. GPSR requires ongoing post-market safety monitoring and corrective action throughout a product's lifecycle.

For businesses, GPSR compliance is not optional and not transitional -- it has been applicable since 13 December 2024. Every consumer product placed on the EU market must meet the general safety requirement. Every product must be traceable, including through a new requirement for electronic contact information. Every economic operator in the supply chain has defined obligations. And every online marketplace must maintain internal product safety processes that go far beyond passive listing.

2,000+
ALERTS/YEAR
Safety Gate dangerous product notifications annually
2 days
REMOVAL
Maximum time for marketplaces to remove unsafe product listings
30
EEA STATES
National contact points in the Safety Gate network
70%+
ONLINE
EU consumers regularly purchasing products online
Apr 23, 2026
YOU ARE HERE

GPSR assigns specific duties to each actor in the supply chain. Select an operator type to see their obligations.

ManufacturerThe entity that designs and produces the product, or has it designed or produced, and markets it under their name or trademark.
General safety requirement
Ensure products only present acceptable minimum risks consistent with a high level of protection for consumers.
Internal risk analysis
Carry out an internal analysis of potential risks before placing the product on the market, and maintain technical documentation.
Traceability information
Place on the product the manufacturer name, registered trade name or trademark, postal address, and electronic contact point.
Product identification
Ensure products bear a type, batch, serial, or model number or other element allowing identification.
Instructions and safety information
Provide clear instructions and safety information in the language of the Member State where the product is made available.
Corrective measures
Take immediate corrective action (withdrawal, recall, warning) when a product presents a risk, and notify authorities.
Accident reporting
Inform competent authorities immediately when aware of accidents caused by the product.

Articles 22 and 23 of GPSR introduce the most significant regulatory change for digital commerce platforms. For the first time, online marketplaces are explicitly named as obligated parties under EU product safety law, with specific duties that go far beyond the DSA's general intermediary liability framework.

01
Single Point of Contact
Designate a single point of contact for market surveillance authorities of all Member States. This contact must be responsive and capable of acting on safety notifications.
02
Seller Verification (KYS)
Before allowing a product to be listed, obtain from the trader: name, address, contact details, and information identifying the product. This "know your seller" requirement applies to all products, not just high-risk categories.
03
Listing Information Requirements
Ensure product listings display: manufacturer name, postal and electronic contact, product images, product identification (type, batch, serial number), and any warnings or safety information required by EU law.
04
Safety Gate Integration
Register with and monitor Safety Gate alerts. When a product on your platform is the subject of a Safety Gate notification, remove the listing and take measures to prevent relisting.
05
2-Working-Day Removal
When ordered by a market surveillance authority, remove illegal content or disable access to products within 2 working days. This is a hard deadline with no extension provision.
06
Consumer Recall Notification
When a product sold through the marketplace is recalled, inform all identifiable consumers who purchased it. Include the specific risk, corrective measures, and instructions for consumers.
07
EU Responsible Person Requirement
Ensure every product listed has an economic operator established in the EU who is responsible for GPSR compliance. If no manufacturer, importer, or authorised representative exists in the EU, the product must not be made available.

The EU rapid alert system for dangerous non-food products. GPSR strengthens its role and integrates it with marketplace obligations.

GPSR strengthens recall obligations with direct consumer notification duties and structured remedy requirements.

A safety issue is identified through internal testing, consumer complaints, market surveillance, accident reports, or Safety Gate alerts.

KEY ACTIONS
Assess whether the risk triggers a mandatory notification obligation
Document the identified risk with technical evidence
Determine the scope: affected product types, batches, serial numbers, and time period
Initiate internal escalation to responsible safety officer

GPSR operates alongside -- not in place of -- EU harmonisation legislation. Understanding the boundary is critical for compliance.

Harmonised Products (with CE Marking)
GPSR acts as a safety net. Products covered by specific EU harmonisation legislation (Machinery Regulation, Low Voltage Directive, Toy Safety, etc.) are subject to GPSR only for safety aspects not addressed by the sectoral rules.
EXAMPLE:A CE-marked electrical appliance complies with the Low Voltage Directive for electrical safety, but GPSR applies to non-electrical risks (e.g., mechanical hazards, chemical exposure) not covered by the directive.
Non-Harmonised Products (no CE Marking)
GPSR is the primary safety regulation. Products without specific EU harmonisation legislation rely entirely on the GPSR general safety requirement and its assessment criteria (EU/national standards, Commission recommendations, state of the art, consumer expectations).
EXAMPLE:Furniture, children's clothing, hobby equipment, and household items without CE marking obligations must comply with GPSR as the applicable product safety framework.
Partially Harmonised Products
Where sectoral legislation covers some but not all safety aspects, GPSR fills the gaps. The manufacturer must identify which risks are addressed by harmonised legislation and which fall under GPSR.
EXAMPLE:A radio-controlled drone is CE-marked under the Radio Equipment Directive for electromagnetic compatibility, but GPSR covers physical safety risks like blade injuries or fire hazards not addressed by the RED.
Market Surveillance and Enforcement
Even for CE-marked products, GPSR strengthens the enforcement toolkit. Market surveillance authorities can use GPSR powers (product recalls, destruction of unsafe products) alongside sector-specific enforcement where needed.
EXAMPLE:If a CE-marked toy is found to have a previously unidentified choking hazard not covered by the Toy Safety Directive, authorities can use GPSR powers to order its recall.
01
General Safety Requirement
Only safe products may be placed on the EU market. Safety is assessed against European standards, product risks, consumer expectations, and the state of the art. Products must not present any risk, or only the minimum risks compatible with a high level of protection.
02
Traceability Throughout the Chain
Every product must be identifiable and traceable back to the manufacturer. Manufacturer name, postal address, electronic contact, and product identification must appear on the product or packaging. Importers must add their own details.
03
Internal Risk Analysis
Manufacturers must carry out an internal analysis of potential risks before placing a product on the market. This includes foreseeable use, vulnerable consumer groups, and risks arising from the product's digital functionality or connectivity.
04
Marketplace Accountability
Online marketplaces are obligated parties with specific duties: seller verification, listing information requirements, Safety Gate integration, 2-day removal compliance, and direct consumer notification for recalls.
05
Strengthened Recalls
Product recalls must include direct consumer notification where possible. Consumers must be offered effective remedies (repair, replacement, or refund) without disproportionate burden. Online marketplaces must notify consumers who purchased recalled products through their platform.
06
Enhanced Market Surveillance
National authorities gain expanded enforcement powers including product destruction, border interception coordination with customs, and the ability to order marketplace content removal within 2 working days. Cross-border coordination is strengthened through the Safety Gate network.

Select your company type for tailored compliance guidance.

KEY OBLIGATIONS
Ensure all consumer products meet the general safety requirement before market placement
Conduct internal risk analysis and maintain technical documentation for each product type
Place manufacturer name, postal address, and electronic contact on all products
Ensure product identification (type, batch, or serial number) on every product
Provide safety instructions in the language of each Member State where the product is sold
Implement corrective actions (recall, withdrawal, warning) when a safety issue is identified
Report product-related accidents to competent authorities immediately
Monitor product safety post-market and respond to Safety Gate alerts
YOUR FIRST STEP

Conduct a comprehensive GPSR gap analysis across your product portfolio: verify traceability markings (including new electronic contact requirement), review risk assessment documentation, and update recall procedures to meet direct consumer notification obligations.

JUR.TITLESTATUSLINKS
EURegulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC (Text with EEA relevance)Adopted8
EURegulation (EU) 2017/2394 of the European Parliament and of the Council of 12 December 2017 on cooperation between national authorities responsible for the enforcement of consumer protection laws and repealing Regulation (EC) No 2006/2004 (Text with EEA relevance)Adopted6
EUCommission Implementing Regulation (EU) 2025/2526 of 16 December 2025 amending Implementing Regulation (EU) 2023/2713 to correct the designation of an EU reference laboratory and to designate European Union reference laboratories for in vitro diagnostic medical devices intended for detection or quantification of markers of parasite infection and detection of blood grouping markersAdopted1
EUCommission Implementing Regulation (EU) 2025/2086 of 17 October 2025 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medical devices and in vitro diagnostic medical devices at Union level, as well as templates for those joint clinical assessmentsAdopted1
EUCommission Implementing Regulation (EU) 2025/1234 of 25 June 2025 amending Implementing Regulation (EU) 2021/2226 as regards the medical devices for which the instructions for use may be provided in electronic formAdopted1
EUCommission Implementing Regulation (EU) 2025/1197 of 19 June 2025 imposing an International Procurement Instrument measure restricting the access of economic operators and medical devices originating in the People’s Republic of China to the European Union public procurement market for medical devices pursuant to Regulation (EU) 2022/1031 of the European Parliament and of the CouncilAdopted1
EUCommission Implementing Regulation (EU) 2025/117 of 24 January 2025 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devicesAdopted1
EUCommission Implementing Regulation (EU) 2024/2958 of 29 November 2024 determining the output indicators relevant for Regulation (EU) 2023/988 of the European Parliament and of the Council on general product safetyAdopted1
EUCommission Implementing Regulation (EU) 2024/2699 of 18 October 2024 laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devicesAdopted1
EUCommission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devicesAdopted1
VIEW ALL →
DATEJUR.TITLESTATUS
Dec 16, 2025EUCommission Implementing Regulation (EU) 2025/2526 of 16 December 2025 amending Implementing Regulation (EU) 2023/2713 to correct the designation of an EU reference laboratory and to designate European Union reference laboratories for in vitro diagnostic medical devices intended for detection or quantification of markers of parasite infection and detection of blood grouping markersAdopted
Oct 17, 2025EUCommission Implementing Regulation (EU) 2025/2086 of 17 October 2025 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medical devices and in vitro diagnostic medical devices at Union level, as well as templates for those joint clinical assessmentsAdopted
Jun 25, 2025EUCommission Implementing Regulation (EU) 2025/1234 of 25 June 2025 amending Implementing Regulation (EU) 2021/2226 as regards the medical devices for which the instructions for use may be provided in electronic formAdopted
Jun 19, 2025EUCommission Implementing Regulation (EU) 2025/1197 of 19 June 2025 imposing an International Procurement Instrument measure restricting the access of economic operators and medical devices originating in the People’s Republic of China to the European Union public procurement market for medical devices pursuant to Regulation (EU) 2022/1031 of the European Parliament and of the CouncilAdopted
Jan 24, 2025EUCommission Implementing Regulation (EU) 2025/117 of 24 January 2025 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devicesAdopted
Nov 29, 2024EUCommission Implementing Regulation (EU) 2024/2958 of 29 November 2024 determining the output indicators relevant for Regulation (EU) 2023/988 of the European Parliament and of the Council on general product safetyAdopted
Oct 18, 2024EUCommission Implementing Regulation (EU) 2024/2699 of 18 October 2024 laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devicesAdopted
Jun 13, 2024EURegulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices (Text with EEA relevance)Adopted
Dec 5, 2023EUCommission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devicesAdopted
Nov 13, 2023EUCommission Regulation (EU) 2023/2482 of 13 November 2023 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devicesAdopted
Jul 27, 2023EUCorrigendum to Commission Delegated Directive (EU) 2023/1526 of 16 May 2023 amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride used as base material in sensors used in in vitro diagnostic medical devices (Official Journal of the European Union L 185 of 24 July 2023)Adopted
May 16, 2023EUCommission Delegated Directive (EU) 2023/1526 of 16 May 2023 amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride used as base material in sensors used in in vitro diagnostic medical devices (Text with EEA relevance)Adopted
May 10, 2023EURegulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC (Text with EEA relevance)Adopted
Mar 15, 2023EURegulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (Text with EEA relevance)Adopted
Dec 1, 2022EUCommission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (Text with EEA relevance)Adopted