GPSR Compliance: What Every Product Company Needs to Know in 2026

The General Product Safety Regulation (EU) 2023/988 — known as GPSR — is the EU's overhaul of consumer product safety law. It replaced the decades-old General Product Safety Directive (2001/95/EC) and has applied across all EU Member States since 13 December 2024. If you manufacture, import, distribute, or sell non-food consumer products on the EU market, GPSR applies to you — regardless of where your company is based.

GPSR matters now more than ever because enforcement is ramping up. Market surveillance authorities across the EU are actively using their expanded powers, the Safety Gate system is processing record numbers of product safety notifications, and online marketplaces like Amazon have begun requiring GPSR compliance documentation from sellers. Companies that haven't adapted risk product delistings, recalls, and fines.

The previous General Product Safety Directive (GPSD) served as the EU's safety net for consumer products since 2001. GPSR doesn't just update it — it fundamentally expands the scope and sharpens the obligations.

Three changes stand out. First, GPSR is a regulation, not a directive. That means it applies directly and uniformly across all 27 EU Member States — no more variation in how countries interpret the rules. Second, it introduces the concept of a mandatory "responsible person" established in the EU for every product on the market. Third, it imposes specific obligations on online marketplaces for the first time, closing a gap that allowed unsafe products to reach consumers through e-commerce channels.

For product companies, the shift from directive to regulation means one set of rules, one compliance standard, and less ambiguity. But it also means tighter enforcement and higher expectations.

Does GPSR apply to all consumer products?

GPSR applies to all products placed on or made available on the EU market that are intended for consumers — or likely to be used by consumers — under reasonably foreseeable conditions. This includes products used in the context of providing a service. Products covered by specific EU harmonisation legislation (such as toys, electronics, or medical devices) are partially exempt: GPSR fills the gaps where sector-specific rules don't address particular safety aspects. Food, feed, medicinal products, and plants are excluded entirely.

How is GPSR different from CE marking requirements?

CE marking applies to product categories covered by specific EU directives and regulations — think the Toy Safety Directive, the Low Voltage Directive, or the Machinery Regulation. GPSR is the safety net underneath all of those. If your product falls under a CE marking directive, you still need to comply with that directive, but GPSR adds requirements on areas like traceability, internal risk analysis, and the responsible person obligation that the sector-specific rules may not cover. For products not covered by any CE marking directive — such as furniture, clothing, or household items — GPSR is the primary safety law.

GPSR defines obligations for every economic operator in the supply chain — manufacturers, importers, distributors, fulfilment service providers, and online marketplaces. Here's what each role requires.

Manufacturers bear the heaviest obligations. Under Article 9 of GPSR, manufacturers must ensure their products are safe before placing them on the market. This means conducting an internal risk analysis, preparing technical documentation that demonstrates safety, and ensuring products carry the required identification and contact information — including a type, batch, or serial number, the manufacturer's name, postal address, and email address. Where the product's size makes this impractical, the information must appear on the packaging or an accompanying document.

Importers must verify that the manufacturer has fulfilled these obligations before placing a product on the EU market. Under Article 11, importers must ensure that the product bears the required markings and is accompanied by safety information in a language easily understood by consumers in each Member State where it will be sold.

Distributors must act with due care. Under Article 12, distributors must verify that the product bears the required identification and that the manufacturer and importer (where relevant) have complied with their labelling and information obligations.

Online marketplaces face new requirements under Article 22. Marketplace providers must register with the Safety Gate portal, designate a single point of contact for market surveillance authorities, and take down products flagged as dangerous. This is a significant change — marketplaces can no longer claim to be passive intermediaries when it comes to product safety.

Article 16 of GPSR introduces what is arguably the most impactful new requirement: every product placed on or made available on the EU market must have a responsible person established in the EU.

The responsible person is the economic operator who takes accountability for the product's compliance with GPSR. This can be the manufacturer (if EU-based), the authorized representative, the importer, the distributor, or the fulfilment service provider. If none of these is established in the EU, the product cannot legally be placed on the market.

What does the responsible person actually do?

The responsible person's duties under Article 16(2) include verifying that technical documentation has been drawn up — including a risk analysis and a list of applicable standards — making this documentation available to market surveillance authorities on request, cooperating with authorities when a product presents a risk, and informing authorities when they have reason to believe a product is dangerous. The responsible person's name, trade name or trademark, and contact details (postal and electronic) must appear on the product, its packaging, the parcel, or an accompanying document.

Why does this matter for non-EU companies?

For manufacturers based outside the EU — whether in China, the US, the UK, or elsewhere — the responsible person requirement means they must either establish an EU presence themselves or formally appoint an EU-based partner (such as an authorized representative or importer) to fulfil this role. Products without a designated responsible person in the EU are non-compliant, full stop.

GPSR requires manufacturers to prepare technical documentation for every product. This isn't optional, and it isn't a box-ticking exercise — it must contain a genuine analysis of possible risks and the solutions adopted to eliminate or mitigate them.

Under Article 9, the technical documentation must include at least a general description of the product and its essential characteristics relevant to safety, an analysis of possible risks related to the product, and a list of relevant EU harmonised standards or other technical specifications used to address safety requirements. Market surveillance authorities can request this documentation at any time, and the responsible person must be able to provide it.

For companies managing large product portfolios, this requirement translates to hundreds or thousands of individual technical files — each of which must be kept up to date as products change or new risks emerge.

What counts as a risk analysis under GPSR?

GPSR doesn't prescribe a single methodology for risk analysis. However, the analysis must consider foreseeable use and reasonably foreseeable misuse of the product. It should address risks related to the product's characteristics — including its composition, packaging, assembly instructions, and maintenance — as well as the effect on other products where combined use is reasonably foreseeable. The analysis must also consider the presentation of the product, its labelling, any warnings or instructions, and the categories of consumers at risk, especially vulnerable groups such as children and elderly persons.

GPSR significantly strengthens the framework for product recalls. When a product is recalled, economic operators must directly notify affected consumers — where contact details are available — and offer a remedy. Article 37 establishes what the regulation calls a "product safety recall remedy right," requiring operators to offer consumers a choice between repair, replacement, or a full refund, free of charge.

Incidents involving serious risks must be reported to authorities within two working days through the Safety Business Gateway — the business-facing portal of the EU's Safety Gate system. The Safety Gate system has seen significantly increased activity since GPSR took effect, reflecting both heightened market surveillance and more proactive reporting by economic operators.

Article 44 of GPSR requires Member States to lay down rules on penalties for infringements that are "effective, proportionate and dissuasive." The regulation does not set specific fine amounts — that is left to each Member State — but the direction is clear: penalties are getting stricter.

Several Member States are introducing substantial fines. Beyond fines, enforcement actions can include product withdrawals, recalls, and — for online sales — delisting from marketplaces.

Market surveillance authorities also have expanded powers under GPSR to order products removed from the market, require modifications, and mandate that economic operators take corrective actions. For companies selling on platforms like Amazon or Zalando, non-compliance can result in swift product takedowns.

If your company hasn't yet adapted to GPSR, here's where to focus.

If mapping GPSR requirements across a growing product portfolio is consuming your team's time, see how Complir automates regulatory mapping and documentation for consumer product companies — so your team can focus on getting products to market instead of chasing compliance paperwork. Learn more at complir.io

Sources & References

• General Product Safety Regulation (EU) 2023/988 — EUR-Lex Official Text
• EU Access2Markets — GPSR Overview — European Commission
• U.S. Commercial Service — EU Consumer Goods GPSR — Trade.gov
• EU Regulation 2023/988 Detailed Guidance — GOV.UK
• GPSR: Responsible Person Role — PRODlaw.eu

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.