Reg. (EU) 2023/988 · Art. 9 Generate — €49

GPSR requirements for US Amazon sellers selling in Europe: the complete operational checklist.

If you are a US-based Amazon seller with listings active in Amazon DE, FR, IT, ES or NL, the GPSR applies to you. This has been true since 13 December 2024, and Amazon started enforcement at the listing level on 1 April 2024 — eight months before the regulation even entered into force. The US-seller-to-EU-market pathway is one of the most enforced segments of the GPSR because Amazon has visibility into both sides of the transaction and because non-EU sellers are, by Article 16, required to have an EU-based Responsible Person on record. This landing lays out the full operational checklist: what documents are required, what Amazon is specifically checking, how the EU Responsible Person works, and how GPSRCheck fits into all of it.

Generate GPSR Technical File Free diagnostic: do you need GPSR documentation?

€49 per product · 10 minutes · 6-page PDF: technical file + EU Declaration of Conformity + printable label · 100% in your browser · Permanent PDF · 30-day edit window, up to 10 regenerations

Built on Regulation (EU) 2023/988·Article 9 internal risk analysis·EU Declaration of Conformity included·Printable product label·Data never leaves your browser

The five obligations US sellers have under the GPSR

1

Technical file per SKU

Every non-food consumer product listed on an EU Amazon marketplace needs an Article 9 technical file: internal risk analysis, product description with intended use and foreseeable misuse, list of applicable EU standards, EU Declaration of Conformity. This is the document Amazon Seller Central asks you to upload. This is what GPSRCheck generates.

2

EU Responsible Person

Under Article 16, every product placed on the EU market by a non-EU manufacturer must have a designated Responsible Person established in the EU — whose name and contact details appear on the product label and who responds to market surveillance requests. Contracted separately from any EU-based provider, typically €150 to €300 per year.

3

Product label with traceability data

The label must carry the manufacturer’s name and address, the EU Responsible Person’s name and contact, and traceability identifiers (model, batch, serial where applicable). GPSRCheck generates a printable label on page 6 of the PDF.

4

Safety Gate readiness

If a safety issue emerges after the product is on the market, the manufacturer must notify member state authorities via the Safety Business Gateway. This is a reactive obligation — you do not file anything in advance, but you must have the internal procedure ready.

5

Document retention

The technical file must be retained for 10 years from the date the last unit was placed on the market.

What is different for a US seller versus an EU-based seller

Difference 1

Cannot self-designate as Responsible Person

An EU-based seller with an EU entity can self-designate. A US seller must contract a separate EU-based Responsible Person. This is a permanent ongoing cost.

Difference 2

Time zone creates a response-window problem

When a German BAuA or French DGCCRF inspector emails with a 10-day deadline, you have 10 calendar days, not 10 business days, and the email may arrive at 3am your time. The technical file needs to be ready before the email arrives.

Difference 3

Amazon’s flags are asymmetric

A US seller with a missing GPSR file typically gets flagged faster and reinstated slower than an EU-resident seller, because Amazon’s automated systems treat non-EU manufacturers as higher-risk.

The GPSR is not the same as the CPSC, and your US certifications do not carry over

The US Consumer Product Safety Commission (CPSC) framework and the EU GPSR are two independent regulatory regimes. Nothing from the US side — ASTM testing, FCC certification, UL listing, CPSIA children’s product certificates, Prop 65 compliance — transfers automatically to the EU framework. The EU regime requires an EU-referenced Declaration of Conformity citing Regulation (EU) 2023/988, an internal risk analysis referencing EN standards (not ASTM or ANSI), and a Responsible Person under Article 16 that has no US equivalent.

For US sellers building a first-time EU compliance package, the correct mental model is: your US certifications stay in place for the US market, and a separate EU compliance package is built on top for the EU market. GPSRCheck produces the EU compliance package.

What’s in the 6-page PDF

1

Product identification and traceability

Manufacturer name and address, EU Responsible Person placeholder, SKU, batch reference, product category.

2

Product description, intended use and foreseeable misuse scenarios

How the product is designed to be used, and what a reasonable user might do with it outside that scope.

3–4

Article 9 internal risk analysis

Hazard identification, likelihood and severity assessment, mitigation measures, residual risk statement.

5

EU Declaration of Conformity

Signed template referencing Regulation (EU) 2023/988 and any additional applicable directives (LVD, EMC, RoHS, toy safety, etc. as applicable).

6

Printable product label

Traceability block and EU Responsible Person placeholder, ready to print at 45×25 mm or scale up.

Every page is generated locally in your browser. Nothing is uploaded to our servers. The file is yours the moment you close the tab.

The technical file and the EU Responsible Person: two separate things

The GPSR has two distinct compliance layers for non-EU sellers, and vendors in this market often bundle them into one expensive annual contract. They don’t have to be bundled.

● Layer 1 — Article 9 (GPSRCheck does this)

The technical file

The documented internal risk analysis, the EU Declaration of Conformity, the product label with traceability data. This is the document Amazon Seller Central asks you to upload. GPSRCheck generates it in 10 minutes for €49 per SKU. One license per SKU. The PDF you download is yours permanently and does not expire. The license lets you regenerate the file up to 10 times within 30 days from first activation to correct details.

∅ Layer 2 — Article 16 (separate service)

The EU Responsible Person

Every non-EU manufacturer must appoint an EU-established economic operator as regulatory contact — a service, not a document. Typical pricing €150 to €300 per year. You can pick any provider and combine it with your GPSRCheck files. The PDF you download is yours to keep and is not tied to any Responsible Person contract.

The industry standard is to bundle both layers into a single annual subscription of €199 to €2,000, which means you cannot leave the vendor without losing access to your own documentation. We decouple the two on purpose: you own the document, you pick the Responsible Person separately, and if you ever change provider, your files travel with you.

Enforcement reality — the timeline that built this market

📅
1 April 2024 — Amazon begins enforcement

Amazon started suspending EU listings without a valid EU Responsible Person — eight months before the GPSR’s official entry into force. Amazon moved ahead of the regulator.

⚖️
13 December 2024 — GPSR enters into force

Regulation (EU) 2023/988 entered into force across all 27 EU member states plus Northern Ireland. Every non-food consumer product placed on the EU market must have a documented Article 9 internal risk analysis and an EU Responsible Person under Article 16.

Ten-day response window

When a market surveillance authority in any EU member state issues a reasoned request for the technical file, the economic operator has ten days to provide it. Missing this window is treated as a presumption of non-compliance and triggers listing removal, cargo detention or sales ban.

⚖️
National fines up to €100,000+

Member states are implementing national penalty regimes. Germany additionally imposes criminal penalties of up to one year of imprisonment. France allows proportional fines up to 10% of annual turnover. Italy, Spain, Netherlands and Poland have enacted comparable ranges.

🔒
Safety Gate — permanent public listing

Products flagged as non-compliant are listed publicly, by brand and model. Inclusion is permanent and searchable — the reputational damage outlasts any fine.

⚓️
Customs blockage at EU ports

Customs may detain shipments without valid GPSR documentation, accruing daily storage costs until documentation is produced or the shipment is returned.

Why GPSRCheck rather than a consultancy or an annual subscription?

 ConsultancyAnnual subscription platformGPSRCheck
Price€400–2,000 per product€199–600 per year€49 per product
Time to delivery3–15 business days48h onboarding + setup10 minutes
Billing modelQuote-based invoiceAnnual recurringOne payment per SKU · Permanent PDF · 30-day edit window
EU Responsible PersonIncluded in packageIncluded in packageSeparate (pick any provider)
Legal basisArt. 9 Reg. (EU) 2023/988Art. 9 Reg. (EU) 2023/988Art. 9 Reg. (EU) 2023/988
Data handlingSent to consultancyStored on vendor servers100% in your browser
PortabilityFile belongs to consultancyFile tied to subscriptionFile is yours, travel-ready

40 SKUs in your Amazon EU catalog? One file at a time is not a plan.

Need GPSR technical files at volume? For high-volume catalogues and special pricing, visit solidwaretools.com or email hello@solidwaretools.com.

Commercial enquiries
Commercial enquiries via solidwaretools.com or hello@solidwaretools.com

Frequently asked questions

I already pay for a US-based compliance consultant. Can they produce the EU file too?
Some can, most can’t — and the ones who can typically quote $1,500 to $3,000 per SKU. The Article 9 internal risk analysis has a specific structure that differs from the CPSC framework. If your consultant does not work regularly with Regulation (EU) 2023/988 and EN standards, the file they produce may be rejected by Amazon or by an EU authority.
Do I need a separate Responsible Person for each product or can one cover my whole catalog?
Most EU-based Responsible Person providers offer catalog-level coverage — one contract covers all your SKUs up to a volume cap. Price ranges from €150 to €300 per year for the base tier.
If my listings are only on Amazon.co.uk and not on any EU marketplace, does the GPSR apply?
The UK has retained the GPSR framework for Northern Ireland but not for Great Britain. If you sell only to Great Britain, UK product safety rules apply instead. If your shipping zones include Northern Ireland, the GPSR applies.
What’s the fastest way for a US seller to get one SKU compliant for a listing reinstatement?
Generate the technical file in GPSRCheck (10 minutes, €49), upload the PDF to the Seller Central compliance field, and separately contract an EU Responsible Person (24 to 48 hours for onboarding). Amazon’s reinstatement review then takes another 24 to 72 hours. Total: 2 to 5 calendar days.
Can I put a US address on the product label?
The manufacturer address on the label can be US — that’s your address as the private label brand owner. But the label also has to carry the EU Responsible Person’s name and EU address. Both addresses appear on the label together.
Does a single technical file cover multiple Amazon marketplaces (DE, FR, IT, ES, NL)?
Yes. The GPSR is a single-market regulation — one file per SKU covers all 27 EU member states plus Northern Ireland. The Seller Central compliance upload is per-ASIN, but the same PDF works across all EU storefronts.

⚠️ Important notice: GPSRCheck is a self-assessment documentation tool, not legal advice and not a product testing service. The Article 9 technical file is generated from your input data. GPSRCheck does not provide the EU Responsible Person service.

Five obligations. One document layer. Generate it in 10 minutes.

6 pages. 10 minutes. €49 per SKU. The EU compliance package for a US seller selling on Amazon EU — built on Regulation (EU) 2023/988, ready to upload to Seller Central.

€49 per product
6-page PDF · 10 minutes · €49 per SKU · 100% in your browser · Permanent PDF, 30-day edit window
Generate the Technical File
✓ Last regulatory check: 27 April 2026 · No substantive changes detected · View history