You are already shipping to EU customers. Do not switch it off yet.

Turning EU shipping off is the usual first move

The commonest response to discovering EU compliance mid-trade is to turn EU shipping off. Here is a merchant on the Shopify community doing exactly that:

I've cut off shipping to the EU until I can get this figured out.

And another, on the same subject:

It seems ridiculous that there is no threshold or concessions for small businesses.

Neither of those posters sells cosmetics, and that is the point. Both are reacting to the General Product Safety Regulation, which is where almost all of this conversation is happening — and it is why cosmetics brands keep arriving at the wrong page with the wrong deadline in their heads.

The correction: GPSR is the smaller half

Regulation (EU) 2023/988 — the General Product Safety Regulation — has applied since 13 December 2024 (Art. 52, Reg. (EU) 2023/988). It is the reason marketplaces started asking every seller for an EU economic operator, and it is the reason your Shopify forum is full of people panicking about a December rule.

For a cosmetic product, it is the smaller half of the problem.

Regulation (EC) No 1223/2009 has applied to cosmetics for far longer, and it asks for more. Before a cosmetic product is placed on the Union market it needs a responsible person established in the Union (Art. 4(1), Reg. (EC) 1223/2009), a safety assessment and safety report (Art. 10(1)), a product information file (Art. 11(1)) and a notification (Art. 13(1)), and the pack has to carry the responsible person's name and address (Art. 19(1)(a)).

So: you are not facing a new December rule. You are facing an older one that a marketplace announcement has just made visible to you. That is a different emotional situation and, usefully, a different practical one — because the older obligation has a well-worn route through it and the route is the same whether you discovered it today or three years ago.

Am I in breach right now?

If a product is on the EU market without a responsible person, a safety report, a file and a notification, then Art. 4, 10, 11 and 13 already apply to it: those obligations attach at placing on the market, and if EU customers have your product in their hands, placing has happened. That is not a new obligation you are behind on; it is a known job being done late, and the correction is the same work as a launch.

What a page written for everybody cannot tell you is how far back it reaches, because that turns on facts about your operation rather than about your website. Here is the mechanism your answer runs on.

The obligations in Art. 10, Art. 11 and Art. 13 attach before the product is placed on the market. The Regulation defines two adjacent terms and keeps them apart:

• Making available on the market — any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge (Art. 2(1)(g), Reg. (EC) 1223/2009).
• Placing on the market — a cosmetic product's first making available on the Community market (Art. 2(1)(h)). The Regulation says "Community"; read it as the Union.

Whether a particular direct-to-consumer shipment counts as placing your product on the Union market depends on how the goods actually reach the customer: who imports, who holds stock where, whose name is on the customs entry, whether an EU fulfilment centre or a marketplace sits in the middle. Those are facts about your operation, not about your website.

Separately, Regulation (EU) 2019/1020 deems an online offer targeted at end users in the Union to be made available on the market (Art. 6) — making available, not placing, but enough to bring the offer into scope. Selling from Shopify or Etsy →

So: run the check first — it is free, it needs no email address, and it turns a vague worry into a list of what this specific product is missing. Then bring us the route, the dates and the volumes for the part a page cannot answer. What to do about orders already shipped is a question about your own exposure, and it gets a real answer once we can see the route.

Why "small business" does not get you out of it

There is no turnover threshold and no small-business concession in Regulation (EC) 1223/2009 that we have been able to find. The obligations attach to the product being placed on the market, and to the person designated as responsible for it (Art. 4(1), Art. 5).

This is genuinely unfair in one specific way, and it is worth naming rather than pretending otherwise: the fixed cost of a safety assessment does not scale down with your order book. A brand shipping forty jars a month into the EU carries the same document set as one shipping forty thousand. What can scale is how many of your products you take through at once and in what order, which is a commercial decision we would rather help you make than have you make by switching the market off.

What actually happens if you keep shipping

There is a version of this paragraph that lists fines, recalls and customs seizures. It is not useful to you, because none of those is what actually happens first.

The realistic sequence, in the order people meet it, is: a marketplace blocks a listing and asks for documents; a retailer or distributor asks to see the file before stocking you; a customer asks a question you cannot answer; a payment or logistics partner asks for an EU economic operator. Each of those is a commercial event, and each is resolved by having the file rather than by having an argument.

The way back, in order

1. Find out what your product actually needs. Whether it is a cosmetic at all (Art. 2(1)(a)), which restricted substances are in it, what the label is missing. This is the free check, and it asks for no email address.
2. Settle the formula before the paperwork. If a substance needs a document or a change, you want to know that before you pay for the file.
3. Get the responsible person question settled. A manufacturer established in the Union is the responsible person unless it designates someone by written mandate; for an imported product the importer is, unless it designates otherwise; a distributor becomes the responsible person when it places the product under its own name; and any person established in the Union may be designated by written mandate and accept in writing (Art. 4(3)–(6), Reg. (EC) 1223/2009). We can be appointed as your EU Responsible Person, by written mandate. How that works →
4. Assemble the file. Raw-material documentation is the long pole: specifications, certificates of analysis, allergen statements, the manufacturing method and a GMP statement.
5. Safety assessment and signed report by a person qualified under Art. 10(2).
6. Notify (Art. 13(1)) and print a pack that carries the right name and address (Art. 19(1)(a)).
7. Then re-open EU shipping, with a dated record of what you did and when.

Steps 1 and 2 cost you nothing. Most of the delay after that is a supplier document, not the assessment.

Which products to take first

If you have twelve products and EU sales that justify three, do not start at the top of the catalogue. Three things decide the order, and none of them is your favourite product.

Revenue already coming from the EU. Look at the last twelve months by destination. The line that is actually earning is the line to regularise first.

Shared composition. Products built on one base, differing in colour or pack, are frequently one assessment problem rather than several. Products differing in fragrance usually are not. Sequencing by base rather than by launch date is often the difference between three files and eight.

Documentation you already hold. A product whose raw materials you can evidence today will move quickly. One whose manufacturer has never sent a specification will not, however small it is. Start the document requests for the slow ones on day one and work the fast ones while you wait.

The check tells you, for one product at a time, whether it is a cosmetic and what it is missing — which is the input to the sequencing decision above.

FAQ