The legal chain in four steps
Scope of the regulation
Article 2 of Regulation (EU) 2023/988 defines the scope as “all non-food consumer products placed on the Union market”. There is no geographic carve-out for sellers located outside the EU. The regulation applies to the product’s presence in the market, not to the nationality of the entity selling it.
Who counts as a manufacturer
Article 3 defines “manufacturer” as any natural or legal person who manufactures a product, or has a product designed or manufactured, and markets it under their own name or trademark. When you put your brand on a product sourced from a factory in China, Vietnam or Mexico, the GPSR treats you as the manufacturer — not the factory.
No size threshold
The European Commission’s official FAQ on the GPSR, published in December 2024, confirms that the regulation contains no exemption based on business size. A sole founder with 8 products on Amazon DE has the same obligations as a corporation with 8,000.
Marketplace liability under Article 22
Article 22 places specific obligations on online marketplaces to verify seller compliance and to act on market surveillance requests. This is why Amazon is enforcing the GPSR on your listings — it is Amazon responding to its own legal exposure.
Three myths that keep circulating in FBA communities
“Only big brands need to comply.”
The European Commission FAQ is explicit: exceptions cannot be made based on the size of a business. A solo founder selling 12 SKUs on Amazon DE is subject to the same Article 9 documentation requirement as Xiaomi.
“If my factory has CE certificates, I am covered.”
CE marking and GPSR are separate tracks. The GPSR additionally requires an internal risk analysis conducted by the brand owner — which the factory cannot produce on your behalf, because under the GPSR the brand owner is the manufacturer.
“I only sell in one EU country, so my risk is limited.”
The GPSR is enforced by national authorities in all 27 member states plus Northern Ireland. A market surveillance authority in any member state can request documentation on any product listed for sale to consumers in that country. You are exposed to 28 potential enforcers, not one.
What an FBA private label seller actually owes
What’s in the 6-page PDF
Product identification and traceability
Manufacturer name and address, EU Responsible Person placeholder, SKU, batch reference, product category.
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.
Article 9 internal risk analysis
Hazard identification, likelihood and severity assessment, mitigation measures, residual risk statement.
EU Declaration of Conformity
Signed template referencing Regulation (EU) 2023/988 and any additional applicable directives (LVD, EMC, RoHS, toy safety, etc. as applicable).
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.
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.
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
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.
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.
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.
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.
Products flagged as non-compliant are listed publicly, by brand and model. Inclusion is permanent and searchable — the reputational damage outlasts any fine.
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?
| Consultancy | Annual subscription platform | GPSRCheck | |
|---|---|---|---|
| Price | €400–2,000 per product | €199–600 per year | €49 per product |
| Time to delivery | 3–15 business days | 48h onboarding + setup | 10 minutes |
| Billing model | Quote-based invoice | Annual recurring | One payment per SKU · Permanent PDF · 30-day edit window |
| EU Responsible Person | Included in package | Included in package | Separate (pick any provider) |
| Legal basis | Art. 9 Reg. (EU) 2023/988 | Art. 9 Reg. (EU) 2023/988 | Art. 9 Reg. (EU) 2023/988 |
| Data handling | Sent to consultancy | Stored on vendor servers | 100% in your browser |
| Portability | File belongs to consultancy | File tied to subscription | File 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 enquiriesFrequently asked questions
Does the GPSR apply if I only ship from the US to EU buyers via FBA, and I am not registered as a business in any EU country?
My revenue on Amazon EU is under $10,000 per year. Am I exempt?
What happens if I ignore the Amazon compliance email?
My factory is ISO 9001 certified. Does that count as GPSR compliance?
Can I produce the technical file myself in Word from a template I found online?
How does GPSRCheck differ from the $2,000-per-SKU consultancies?
⚠️ 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.