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

Do I need GPSR compliance if I sell direct to consumer in Europe? Yes — and the reasoning takes three minutes.

Every independent brand founder reaches this question at some point in early 2025 or 2026. The brand is small, the model is direct to consumer, the shipments are individual parcels, and the obvious assumption is that a regulation written with big retailers and marketplaces in mind cannot possibly apply to a lamp atelier in Lyon or a ceramics studio in Porto with a Shopify storefront. The assumption is wrong. The GPSR applies to every non-food consumer product placed on the EU market regardless of how it got there — through a marketplace, through a wholesale retailer, or through a brand’s own D2C storefront. The European Commission confirmed this explicitly in its official FAQ published in December 2024: there is no exception based on business size, shipment volume, sales channel or brand maturity.

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€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 scope question, answered by the regulation itself

Article 2 of Regulation (EU) 2023/988 defines the scope of the GPSR in one sentence: the regulation applies to all non-food consumer products that are either new, used, repaired or reconditioned, placed on the Union market. The scope is determined by the product, not by the seller.

“Placed on the Union market” is a legal term with a specific meaning under EU product legislation: it is the first making available of a product on the Union market, in the course of a commercial activity, whether in return for payment or free of charge. For a D2C brand with a Shopify store, each sale of a product to an EU consumer is a placing on the market. For a designer with an Instagram storefront, same answer. For an artisan selling at Maison&Objet to a collector who takes the piece home, same answer again.

The size of the business, the number of units sold per month, the revenue, the platform, the country of residence of the founder — none of these factors are in Article 2. They are not in the scope definition because the European Commission chose not to include them.

The exemptions that do exist (and why they probably do not cover you)

Article 2 lists explicit exemptions from the GPSR’s scope. The full list is short, and none of it covers typical D2C consumer products:

Medicinal products — regulated under Directive 2001/83/EC or Regulation (EU) 2017/745.
Food and feed — covered by separate EU food safety law.
Live plants and animals and products derived from living organisms intended for consumption as food.
Animal by-products — covered by separate animal health regulation.
Plant protection products (pesticides) — covered by separate regulation.
Equipment on which consumers ride operated by a service provider (e.g., funfair rides operated by a park).
Aircraft equipment in the scope of EU aviation regulation.
Antiques — defined narrowly as objects appreciated for historical or artistic value rather than utility.
Products labelled “to be repaired or reconditioned before use” and sold with that specific marking.

Nothing on that list covers ceramics, wooden furniture, leather goods, clothing, fashion accessories, stationery, non-electronic sports accessories, bags, footwear (non-PPE) or costume jewellery (without electronic components). If your product is not a medicine, a food, a plant, an antique or a funfair ride, the GPSR applies.

What “no size threshold” means in the FAQ from the Commission

The European Commission published a FAQ on the GPSR in December 2024 specifically to address the question that small brand founders kept asking: does this apply to me if I am a one-person business? The Commission’s position was unambiguous. Exceptions cannot be made based on the size of a business. A sole founder selling 20 lamps a month to EU customers has the same Article 9 technical file obligation as a multinational lighting manufacturer.

This is a deliberate policy choice, not an oversight. The legislators who drafted the GPSR were aware that it would capture small D2C brands. Their reasoning, stated in the regulation’s preamble, is that consumer safety cannot depend on the size of the seller — a dangerous lamp is dangerous regardless of whether the maker is a corporation or a sole trader, and the consumer’s right to a safe product is the same in both cases.

For the D2C founder, this means the question is not whether the regulation applies (it does), but how to comply at a cost that is proportionate to the business. GPSRCheck exists for that exact reason: €49 per product, no subscription, so that compliance does not consume the margin on a small line. The PDF you download is permanent.

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

20 products in your line? One file at a time is not a plan.

Need GPSR technical files at volume? For high-volume product lines 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 am a solo designer with a Shopify store that ships 10 lamps a month to Italy and France. Do I really need a GPSR technical file?
Yes. The European Commission’s FAQ is explicit: there is no exemption based on business size or shipment volume. The same applies to a one-person ceramics studio shipping 15 pieces a month or a two-person leather goods brand selling 30 units. The obligation is triggered by placement on the EU market, not by volume.
My products are handmade, not industrial. Does the handmade nature change anything?
No. The GPSR applies to handmade and industrial products equally. A handmade leather bag placed on the EU market is subject to the same Article 9 risk analysis obligation as a mass-produced one. Craftsmanship is not an exemption category.
What if I only sell to one EU country — say, I am a French brand selling only to French consumers?
The GPSR applies. It is an EU-wide regulation but it operates through national market surveillance authorities — in France, the DGCCRF. A French brand selling to French consumers is subject to French enforcement of the GPSR, which uses the same Article 9 standard. Domestic D2C does not reduce the obligation.
I sell on Etsy, not on my own Shopify. Does Etsy handle this for me?
No. Etsy provides the marketplace infrastructure and under Article 22 has specific obligations regarding seller compliance, but the technical file obligation sits with the seller (you) as the manufacturer under Article 3. Etsy has published guidance telling sellers they are responsible for their own GPSR compliance. Check your Etsy seller dashboard for the compliance section.
What happens if I ignore this and just keep shipping?
A market surveillance authority in any member state can request your technical file with a 10-day response window; failure to provide it leads to a product removal order across the EU. A customer can report your product to Safety Gate, which triggers an authority review. A retailer you sell to can be audited and come back to you for the file. The risk is not hypothetical — it is a matter of when, not if.
Is GPSRCheck legally sufficient for a D2C brand, or do I need additional documentation?
For non-regulated consumer categories, the GPSRCheck PDF covers the Article 9 technical file and Declaration of Conformity the regulation requires. Separately, you need: a designated EU Responsible Person (contracted from any EU provider, separate cost), a product label with the required traceability data (generated as page 6 of the PDF), and a process to respond to Safety Gate notifications if a safety issue emerges. For products in regulated categories (toys, PPE, medical devices, machinery), additional documentation is required and a consultancy is the right path.

⚠️ 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.

Yes, the GPSR applies to your D2C brand. Here is the one-time fix.

6 pages. 10 minutes. €49 per product. Article 9 risk analysis + EU Declaration of Conformity + printable label. No subscription, no size threshold, no exemptions for D2C.

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