What Article 9 of Regulation (EU) 2023/988 actually requires
Article 9 of the General Product Safety Regulation imposes a specific structured obligation on manufacturers: every product placed on the EU market must be supported by an internal risk analysis, documented in writing, kept on file for at least 10 years from the date the product was placed on the market, and produced on request to market surveillance authorities or to marketplace compliance teams.
The risk analysis is not a certificate, not a test report, not a CE declaration, not a safety data sheet, and not a marketing brochure. It is a specific document that must contain:
Hazard identification
Across physical, mechanical, chemical, thermal, electrical, radiation, flammability and foreseeable misuse categories.
Severity assessment
Of each identified hazard on a defined scale — the severity × probability matrix Article 9 specifies.
Probability assessment
Of each hazard occurring under normal use and reasonably foreseeable misuse.
Risk rating
Derived from the severity × probability matrix for each identified hazard.
Mitigation measures
Applied to each non-negligible risk: design changes, warning labels, user instructions, packaging changes.
Residual risk statement
After mitigation, justifying why the product is safe enough to place on the market.
This is what the Article 9 document layer looks like. Every consumer product exported from China to the EU needs one. GPSRCheck produces it in the format the regulation specifies, for the product description you provide, in 10 minutes.
Why Chinese manufacturers are the most exposed archetype under GPSR
Volume of SKUs
A Shenzhen trading company with a 200-product catalog faces 200 separate file requirements. A European brand with 15 products faces 15. The paperwork burden scales with catalog size.
Distance from the EU regulator
Market surveillance authorities cannot inspect a factory in Dongguan in person. They rely on documentation — which means the documentation has to exist, be retrievable within days, and be in the format they expect.
Amazon’s enforcement mechanism sits on top
Even before European regulators begin inspecting, Amazon Seller Central is enforcing the documentation requirement at listing level. The primary pressure point is not the EU regulator — it is Amazon suspending the ASIN.
The EU Responsible Person adds a separate layer
Under Article 16, every non-EU manufacturer must appoint an economic operator established in the EU. This is a service, not a document, and is a separate contract from the technical file. See the dedicated section below.
What’s in the 6-page PDF GPSRCheck generates
Cover page
Product identification, manufacturer data, unique file reference and generation date.
Product description
Materials, intended users, foreseeable misuse, and life cycle information.
Internal risk analysis under Article 9
Severity × probability matrix, hazard identification and mitigation measures across physical, mechanical, chemical, thermal, electrical, radiation and flammability categories.
EU Declaration of Conformity
In harmonised format, ready to sign, with legal basis citations to Regulation (EU) 2023/988.
Printable product label (2 copies)
All mandatory GPSR data: manufacturer identification, traceability identifier, safety warnings. Ready to cut and affix. Document retention statement: 10 years from date of market placement.
Generated from your own input, in your own browser. No data leaves your device.
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 product. 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
A separate legal requirement: every non-EU manufacturer must appoint an economic operator established in the EU as the regulatory contact point. This is a service, not a document — typically €150 to €300 per year. You can combine our technical file with any EU Responsible Person provider. The PDF you download is yours to keep and is not tied to any Responsible Person contract.
The industry standard among competitors is to bundle both layers into a single annual subscription of €199 to €2,000. 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 now have a documented Article 9 internal risk analysis and an EU Responsible Person under Article 16.
Member states are implementing national penalty regimes. Fines typically reach up to €100,000 per infraction. Germany additionally imposes criminal penalties of up to one year of imprisonment for persistent infringements. France allows proportional fines up to 10% of annual turnover. Italy, Spain, Netherlands and Poland have enacted comparable ranges.
The EU’s public database of dangerous products (formerly RAPEX). Products flagged as non-compliant are listed publicly, by brand and model. Inclusion in Safety Gate is permanent and searchable — the reputational damage outlasts any fine.
Customs authorities may detain shipments without valid GPSR documentation. The cargo sits in port warehousing, accruing daily storage costs, until documentation is produced or the shipment is returned at the manufacturer’s expense.
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 |
High-volume catalogues and special pricing
For high-volume catalogues and commercial enquiries, visit solidwaretools.com or email hello@solidwaretools.com.
Commercial enquiriesFrequently asked questions
Our factory already holds CE markings for the products we export. Isn’t that enough for GPSR?
Our export department in Shenzhen already downloaded free Article 9 templates. Why would we pay for GPSRCheck?
Can our EU importer produce the technical file on our behalf?
How does the EU Responsible Person requirement interact with the technical file?
What happens if my product is included in the Safety Gate database?
My catalog has 150 active SKUs on Amazon EU. What’s the right way to approach volume?
⚠️ 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.