Guide·

GPSR Compliance: The Complete Guide to the General Product Safety Regulation

What the GPSR (EU 2023/988) requires from manufacturers, importers and online sellers, plus recall rules, enforcement data, and a compliance checklist.

By Complir

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The General Product Safety Regulation (EU) 2023/988 (GPSR) is the EU's baseline product safety law. It requires every consumer product placed on the EU market to be safe, and it has applied since 13 December 2024, replacing the General Product Safety Directive 2001/95/EC. It covers manufacturers, importers, distributors, fulfilment service providers, and online marketplaces, and it applies whether a product is sold in a physical store, on a webshop, or through a marketplace like Amazon or Zalando.

Eighteen months into enforcement, GPSR is no longer a transition topic. The European Commission reported a record 4,671 Safety Gate alerts in 2025, a 13% increase on the previous year, with enforcement actions such as recalls, withdrawals, and marketplace delistings up 35%. This guide covers what the regulation requires, who must do what, how recalls and remedies now work, and how to prepare a portfolio of products for it.

01

What the GPSR Is

From directive to regulation, and why the 2024 change matters

The General Product Safety Regulation is Regulation (EU) 2023/988. It was adopted on 10 May 2023, published in the Official Journal on 23 May 2023, and has applied in full since 13 December 2024. It repealed and replaced two older instruments: the General Product Safety Directive 2001/95/EC (GPSD) and Directive 87/357/EEC on food-imitating products.

Two changes from the directive era matter most in practice. First, GPSR is a regulation, not a directive, so it applies identically in every EU member state without national transposition. Second, it was written for how products are actually sold today: it creates explicit duties for online sales, online marketplaces, and fulfilment service providers that the 2001 directive never contemplated.

GPSR works as a safety net. It fully governs consumer products that are not covered by sector-specific EU harmonisation legislation (furniture, most childcare articles, home textiles, and thousands of other categories), and it fills the gaps for harmonised products (like toys or electronics) on aspects and risks their sector rules do not address.

Key terminology

  • General safety requirement: the core rule in Article 5 of GPSR. Economic operators may only place safe products on the EU market.
  • Economic operator: any manufacturer, authorised representative, importer, distributor, or fulfilment service provider handling a product commercially.
  • Responsible person (Article 16): an economic operator established in the EU who is accountable for compliance tasks for the product. Without one, a consumer product may not be placed on the EU market.
  • Safety Gate: the EU's rapid alert system for dangerous non-food products, where authorities publish alerts and businesses and marketplaces register and respond.
  • Safety Business Gateway: the portal through which businesses notify authorities of accidents and dangerous products.
02

Products and Companies in Scope

What GPSR covers, what it excludes, and where it applies

Products

GPSR applies to consumer products placed or made available on the EU market, whether new, used, repaired, or reconditioned, and whether sold offline or online. Products supplied in the course of a commercial activity are covered even if the consumer pays nothing for them, for example promotional giveaways.

Article 2 of GPSR excludes a small set of categories because dedicated regimes cover them, including medicinal products, food and feed, living plants and animals, plant protection products, transport equipment operated by service providers, and aircraft. Antiques are also excluded, as are products clearly marked as needing repair or reconditioning before use.

Companies and geography

GPSR applies to every business in the supply chain of a consumer product sold in the EU, regardless of where that business is established. A Shenzhen manufacturer selling direct to German consumers through a marketplace is in scope, as is a Danish brand, a French distributor, and the marketplace itself.

Under the Windsor Framework, GPSR also applies in Northern Ireland. Great Britain retains its own framework, currently the General Product Safety Regulations 2005, so companies selling across both markets run two parallel regimes. GB reform is in motion: the Product Regulation and Metrology Act 2025 gives the government powers to modernise the regime, and a consultation on a new GPSR-style framework covering online marketplaces, fulfilment providers, and cybersecurity risks ran from 31 March to 23 June 2026. No new GB framework had been adopted as of August 2026.

Mapping which regime and which requirements apply to each SKU across markets is exactly the work that consumes quality teams at scale. Complir's GPSR compliance software does this mapping automatically across EU regulations and 120+ EN standards.

03

Obligations by Role

What manufacturers, importers, distributors, and responsible persons must do

GPSR assigns duties along the whole supply chain. The table below summarises the core obligations; the sections that follow add the detail.

RoleCore obligations under GPSR
ManufacturerEnsure product safety (Article 5), run an internal risk analysis and prepare technical documentation (Article 9), label with traceability details, report accidents, cooperate on recalls
Importer (Article 11)Verify the manufacturer has met its obligations before placing the product on the market, add name and contact details, keep a copy of the technical documentation for 10 years
Distributor (Article 12)Act with due care, verify required markings and information are present, refuse to supply products they know or should presume are unsafe
Responsible person (Article 16)Be established in the EU, verify documentation exists, provide it to authorities on request, notify dangerous products, ensure corrective action
Fulfilment service providerCan act as the responsible person; handles storage, packaging, and dispatch duties tied to that role

Manufacturers

Article 9 of GPSR requires manufacturers to place only safe products on the market and to be able to demonstrate it. Article 9(2) requires an internal risk analysis for every product and technical documentation that contains at least a general description of the product and its essential safety characteristics, plus an analysis of the possible risks and the solutions adopted to eliminate or mitigate them.

This is the requirement that changes daily work most. Under the old directive, many companies selling non-harmonised products kept no formal safety file at all. Under GPSR, a documented risk analysis per product is a legal baseline, and authorities and marketplaces can ask for it.

Article 6 modernised what safety assessment must consider: the product's characteristics and packaging, its effect on other products it is used with, its appearance (particularly for products that could be mistaken for food by children), cybersecurity features where relevant, and evolving, learning, or predictive functionalities for connected products.

Importers and distributors

Under Article 11 of GPSR, importers may not place a product on the market if they know or should know it does not meet the general safety requirement. They must check that the manufacturer has done its work, add their own name and contact details to the product or its packaging, and keep a copy of the technical documentation for 10 years after the product is placed on the market.

Under Article 12, distributors must act with due care: verify that required markings, warnings, and operator details are present before supplying a product, and stop supplying and inform authorities if they have reason to believe a product is unsafe.

The responsible person: Article 16

Article 16 is the provision most non-EU sellers discover the hard way. A consumer product may only be placed on the EU market if there is an economic operator established in the EU who is responsible for it. GPSR extends the mechanism of Article 4 of Regulation (EU) 2019/1020 on market surveillance, which previously applied only to certain harmonised products, to effectively all consumer products.

The responsible person can be the manufacturer (if EU-based), an importer, an authorised representative appointed in writing, or a fulfilment service provider. Their name and contact details must accompany the product. For a non-EU brand shipping direct to consumers, this means appointing and documenting an EU responsible person per product line before selling, not after a marketplace asks.

Konges Sløjd, which sells children's products through 1,400 stores across 90 countries, uses Complir to keep exactly this chain of documentation (risk assessments, declarations, operator details) attached to every product record instead of scattered across inboxes.

04

Selling Online

Distance sales rules and marketplace obligations

Distance sales: Article 19

Article 19 of GPSR requires that every online product offer includes, before purchase: the manufacturer's name and contact details, the EU responsible person's name and contact details if the manufacturer is outside the EU, information identifying the product (type, batch or serial number, picture), and any warnings or safety information in the languages of the member states where the product is sold.

In practice this turned product detail pages into compliance surfaces. Listings missing operator details are a visible, easily-checked violation, and marketplaces preemptively delist products whose sellers have not supplied the data.

Online marketplaces: Article 22

Article 22 gives providers of online marketplaces their own obligations, separate from sellers'. Marketplaces must register with the Safety Gate portal and name a single contact point, respond to orders from authorities to remove dangerous product listings within two working days, process notices about dangerous products within three working days, make random checks on products offered, and ensure sellers' listings carry the traceability information Article 19 requires.

According to the European Commission, more than 1,200 online marketplaces had registered in the Safety Gate portal by the end of 2025. For brands, the practical consequence is that marketplace compliance teams now enforce GPSR faster than authorities do: missing documentation gets a listing suspended long before a regulator calls.

When a marketplace requests a risk assessment or a Declaration of Conformity, the scramble is rarely doing the work; it is finding the documents. The teams that handle GPSR at scale treat compliance documentation as structured data attached to the product record, so an audit request becomes a lookup instead of a project.

Complir Team

Product Compliance, Complir

05

Accidents, Recalls, and Remedies

Reporting duties, recall notices, and consumer rights

GPSR tightened the whole post-incident chain, and this is where legal exposure concentrates.

Accident reporting. Under Article 20, a manufacturer must notify the competent authorities without undue delay, via the Safety Business Gateway, of accidents caused by its products that result in death or in serious adverse effects on health and safety. Importers and distributors who become aware of such accidents have to inform the manufacturer, who remains responsible for notifying.

Recall notices. Articles 35 and 36 govern how consumers must be informed of recalls and safety warnings. Recall notices must follow a mandatory content standard: plain language, no risk-minimising phrasing (wording like "voluntary recall" or "in rare cases" is out), clear identification of the product, and clear instructions. The Commission has published an official recall notice template in Implementing Regulation (EU) 2024/1435.

Remedies. Article 37 gives consumers a legal right to remedies in a safety recall. The economic operator responsible for the recall must offer the consumer a choice of at least two of these options: repair, replacement, or a refund, except where a second remedy would be impossible or disproportionate. This turned recalls from a communications exercise into a costed consumer-rights process.

Penalties are set at member-state level. Article 44 of GPSR requires member states to lay down penalty rules that are effective, proportionate, and dissuasive, covering economic operators and online marketplace providers alike. The regulation itself sets no amounts; national enforcement acts do.

06

Enforcement So Far

What the first full year of Safety Gate data shows

The first full enforcement year settles the question of whether GPSR would be enforced. According to the European Commission's Safety Gate results published in March 2026, 2025 produced 4,671 Safety Gate alerts, the highest on record and 13% more than the year before. Cosmetics and toys together accounted for over half of reported cases. Follow-up enforcement actions (withdrawals, recalls, border seizures, and removals from online marketplaces) rose 35%.

Two patterns in that data matter for planning. First, the growth is concentrated in exactly the categories where non-EU e-commerce volume is highest, and the Commission has explicitly linked its product safety agenda to imported low-value e-commerce parcels. Second, marketplace delisting is now a standard enforcement outcome, which means the commercial penalty for missing documentation arrives immediately and at listing level.

The European Commission has also published consolidated guidance for businesses: Commission Notice C/2025/6233, Guidelines on the application of the EU general product safety legislative framework, issued on 21 November 2025. It walks through operator obligations, technical documentation, traceability, and use of the Safety Business Gateway and Safety Gate portal, and is written explicitly with small and medium-sized businesses in mind. If you are building a GPSR file from scratch, read it alongside the regulation.

07

How to Prepare

A step-by-step approach for your portfolio

Inventory and classify every product

List every SKU sold in the EU and determine which regime governs it: GPSR alone, or sector legislation with GPSR as the safety net. This classification decides which documentation each product needs, and at portfolio scale it is the step teams underestimate most.

Close the risk-analysis gap

Every product needs the Article 9(2) internal risk analysis and technical documentation. Prioritise products with no sector-specific file today, then products with high Safety Gate activity in their category, such as toys and cosmetics.

Confirm a responsible person per product line

Verify there is an EU-established economic operator accountable for each product, that the appointment is documented, and that their name and contact details appear on the product, packaging, or accompanying documentation.

Fix your listings

Audit online offers against Article 19: manufacturer details, responsible person details, product identification, and warnings in the right languages. This is the fastest check for authorities and marketplaces, so make it the fastest check for you too.

Build the recall playbook before you need it

Define who decides, who notifies authorities through the Safety Business Gateway, how you reach affected consumers, and how you will deliver two remedy options. Use the official template from Implementing Regulation (EU) 2024/1435 as your notice format.

Keep it current

Products change, suppliers change, and regulations update. A GPSR file that was accurate at launch drifts out of date unless ownership and monitoring are assigned.

Complir automates the classification, risk-assessment, and monitoring steps end to end: AI-assisted classification maps each product to its applicable regulations, the risk assessment is generated from the classification, and regulatory monitoring flags affected SKUs when rules change. For the broader process view of running this at portfolio scale, see our guide to product compliance management.

08

Frequently Asked Questions

Quick answers on scope, roles, timing, and penalties

What does GPSR stand for?

GPSR stands for General Product Safety Regulation, formally Regulation (EU) 2023/988. It is the EU's horizontal product safety law for consumer products and has applied since 13 December 2024.

When did the GPSR come into effect?

GPSR was adopted in May 2023 and has applied since 13 December 2024. Products placed on the EU market from that date must comply. GPSR contains a transitional provision for pre-existing stock: member states shall not impede the making available of products that comply with the old directive and were placed on the market before 13 December 2024.

What is the difference between the GPSR and the GPSD?

The GPSD (Directive 2001/95/EC) was a directive that each member state implemented in national law. The GPSR replaced it with a single directly applicable regulation, and added requirements the directive lacked: a documented risk analysis and technical documentation for all products, a mandatory EU responsible person, detailed rules for online sales and marketplaces, accident reporting through the Safety Business Gateway, and consumer remedy rights in recalls.

Does GPSR apply to sellers outside the EU?

Yes. GPSR applies to any product placed on the EU market regardless of where the seller is established. A non-EU seller must ensure there is a responsible person established in the EU (Article 16) before its products can be sold, and online offers must display that responsible person's contact details.

What is a GPSR responsible person?

The responsible person is an economic operator established in the EU who is accountable for the product's compliance tasks: verifying documentation exists, providing it to authorities, and notifying and acting when a product is dangerous. It can be the EU manufacturer, an importer, a written-mandate authorised representative, or a fulfilment service provider. Without one, the product may not be placed on the EU market.

Does GPSR apply to second-hand and refurbished products?

Generally yes, when they are supplied in the course of a commercial activity. GPSR applies to products whether new, used, repaired, or reconditioned. Antiques are excluded, and so are products supplied as needing repair or reconditioning before use, provided they are clearly marked as such.

Do I need a risk assessment for every product?

Manufacturers must carry out an internal risk analysis and draw up technical documentation for products they place on the EU market under Article 9(2) of GPSR. For products also covered by sector legislation (toys, electronics), the sector risk assessment does most of this work; for non-harmonised products, GPSR itself is the source of the obligation.

What are the penalties for GPSR non-compliance?

Penalties are set by each member state and must be effective, proportionate, and dissuasive. The practical first-line consequences are usually commercial rather than fines: marketplace delisting, border detention of shipments, forced recalls, and Safety Gate publication of the product and brand name.

Does GPSR apply in the UK?

GPSR applies in Northern Ireland under the Windsor Framework. Great Britain has its own framework, currently the General Product Safety Regulations 2005, so products sold in both GB and the EU need to satisfy both regimes. A GB reform based on the Product Regulation and Metrology Act 2025 is under way but had not been adopted as of August 2026.

  • CE Marking: harmonised products carry CE marking under their sector legislation; GPSR fills the safety gaps those rules leave. See our CE marking requirements guide.
  • EU Toy Safety Regulation: toys are harmonised products with their own regime, one of the categories dominating Safety Gate alerts. See our EU Toy Safety Regulation guide.
  • Digital Product Passport (DPP): the structured product data GPSR forces you to assemble is the same foundation DPP will require from 2027 onward. See our Digital Product Passport guide.
  • Product compliance management: for the process view of running classification, risk assessment, and documentation at portfolio scale, see How to build a scalable compliance process.
09

What This Means for Your Business

Three non-optional requirements, and how to execute them at scale

GPSR made three things non-optional for anyone selling consumer products in the EU: a documented risk analysis and technical file for every product, an EU responsible person named on every product and listing, and a recall process that can deliver consumer remedies. Enforcement data from the Commission's 2025 Safety Gate results shows the regime is being used, with record alerts and a 35% rise in enforcement actions, and marketplaces have become its fastest enforcers.

If your team is managing this across hundreds or thousands of SKUs in spreadsheets, the constraint is not understanding GPSR, it is executing it at scale. That is the problem Complir was built for: classification, risk assessment, documentation, and monitoring running continuously from one product record. See how Complir's GPSR compliance software works, or book a walkthrough to see it on your own product categories.

Sources & References

  • General Product Safety Regulation (EU) 2023/988: EUR-Lex
  • General Product Safety Directive 2001/95/EC (repealed): EUR-Lex
  • Regulation (EU) 2019/1020 on market surveillance: EUR-Lex
  • Commission Implementing Regulation (EU) 2024/1435 (recall notice template): EUR-Lex
  • Commission Notice C/2025/6233, Guidelines on the application of the EU general product safety legislative framework by businesses (21 November 2025): EUR-Lex
  • Product Regulation and Metrology Act 2025 (UK, 2025 c. 20): legislation.gov.uk
  • European Commission, "Increased action against dangerous products in the EU 2025" (Safety Gate 2025 results, March 2026): European Commission
  • European Commission, GPSR obligations for businesses (Safety Gate / E-Academy): European Commission
  • European Commission, Access2Markets: "EU's General Product Safety Regulation (GPSR): A New Era of Consumer Protection": European Commission

This article is for informational purposes only and does not constitute legal advice. Regulatory requirements may vary by product category, market, and specific circumstances. Consult with a qualified legal professional for compliance guidance specific to your situation.

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