Genuine is not the same as legal: three regulated products and the European rules that decided the deal

An enquiry arrives. A European company wants to bring an American consumer product into the EU, has identified real demand, has worked out the fulfilment, and wants help finding verified wholesalers at origin. The commercial reasoning is sound. The customer need is real. Everything about the brief is competent.

And the product, as formulated for the United States, cannot lawfully be sold to a consumer in the European Union. Not because it is counterfeit — the whole point of the project was authenticity — but because a European rule caps an ingredient at a level the American version exceeds.

That is a hard thing to put in a reply. It is also the most valuable thing we could have said, and it is the reason this piece exists. Across markets and sectors, the pattern repeats: the distributor search is the easy part, and the regulation is what decides whether the search was worth running.

Three cases below. The first is one we were asked about directly. The other two are categories we are asked about often enough that the pattern is worth setting out, because each fails in a different way, and knowing which failure you are exposed to tells you what to check before you spend anything.

1. The product that was genuine and still illegal

The category was tooth whitening — peroxide strips, a large and entirely legitimate American consumer product, sold at retail across the United States without difficulty.

In the European Union, tooth whitening is regulated as a cosmetic, and the Cosmetics Regulation caps hydrogen peroxide in Annex III. The structure is three tiered and unusually blunt:

So the question “where do we buy genuine American stock” has no useful answer, because the formulation that makes the American product work is the formulation that puts it outside consumer retail in Europe. There is no supplier anywhere in the United States who solves that. The constraint is not in the supply chain. It is in the product.

None of this is a criticism of the company that asked. The rule is not intuitive, it is buried in an annex, and the product is sold openly in the market where they saw the demand. An American manufacturer doing nothing wrong, a European buyer doing nothing wrong, and a regulation between them that neither party's commercial instinct would surface.

2. The second wall: authentic goods, unauthorised route

Suppose the formulation problem were solved — an EU-compliant variant exists, or the category changes. A second rule sits behind the first, and it catches a great deal of cross-border consumer trade that looks entirely clean.

Trade mark rights in Europe are exhausted on a regional basis, not a worldwide one. When a trade mark owner puts goods on the market inside the European Economic Area, or consents to that, it can no longer use the trade mark to stop those particular goods being resold. Goods first sold outside the EEA do not exhaust anything. Importing them into the EEA without the owner's consent is an infringement, however genuine they are.

The European Court settled the principle in Silhouette, and then settled the harder question in the Zino Davidoff and Levi Strauss cases: can consent be implied? It can, but only where the importer proves the owner unequivocally renounced the right to object. Three things that are specifically not enough:

• The owner said nothing about imports into the EEA.
• The goods carry no marking prohibiting EEA import.
• No contract restricted the buyer, or any later buyer, from reselling into the EEA.

And the burden sits on the importer, not the brand. Silence is not permission; the absence of a prohibition is not permission. For a business whose entire proposition is that its goods are verifiably genuine, this is a difficult shape of risk, because authenticity is the thing being proven and authenticity is not the thing in dispute.

The practical consequence is that sourcing moves from a question of availability to a question of authority. Not “who has stock” but “who can give, or evidence, the rights-holder’s consent for these goods to be placed on this market”. That is a different search, with a different and much shorter answer set, and it is worth knowing which one you are commissioning.

3. Cosmetics, and the person who owns your market access

The second case is the broader cosmetics category, and here the trap is not what the product is. It is who holds the right to put it on the market.

Under the Cosmetics Regulation, no cosmetic may be placed on the EU market unless a Responsible Person established in the Union is designated for it. The Responsible Person is named on the label. They notify the product through the CPNP portal before it goes on sale. They hold the Product Information File and the safety report, and produce them for authorities on demand. They carry the obligation to act — including withdrawal — if the product turns out to be non-compliant.

Now the part that catches brands. A manufacturer outside the EU can appoint a Responsible Person by written mandate, and that party accepts in writing. But if no Responsible Person has been appointed, the importer becomes it automatically for the products it places on the market. Nobody has to decide this. It happens by operation of the regulation, in the absence of a decision.

Readers of our piece on who holds your product registration will recognise the shape exactly. It is the same trap wearing European clothes: a market-access asset that must be held by a local entity, handed to a commercial counterparty by default because nobody treated it as an asset.

The fix is unglamorous and cheap, which is why it is annoying to miss. The Responsible Person does not have to be your distributor. It can be your own EU entity if you have one, or an independent regulatory services firm whose business is holding exactly this role for brands that would rather not hand it to a seller. Either keeps the commercial relationship and the regulatory relationship in separate hands, which is the whole objective.

And Europe does not stop at the EU border

One further point that surprises brands more than it should: an EU Responsible Person does not cover Great Britain. Since Brexit a product placed on the GB market needs a Responsible Person established in the UK, and notification through SCPN rather than CPNP. Northern Ireland follows the EU position. So “Europe” in a distribution agreement can mean two regulatory regimes, two notifications and two Responsible Persons — and a distributor who is excellent across the EU may hold nothing that helps you in Britain.

4. Nicotine pouches, and the Europe that is not one market

The third case is the one most likely to catch a principal who assumes the single market does more than it does.

Tobacco-free nicotine pouches are a genuinely large and fast-growing European category. They are also, at the time of writing, not covered by the Tobacco Products Directive, which was last revised in 2014, before the products existed commercially. What that means is not light-touch regulation. It means there is no European position at all, and twenty-seven national positions instead — which currently range from ordinary regulated retail to outright prohibition.

The spread, as it stands:

Two things follow. The first is that a single “European distributor” for this category is close to meaningless as a concept: the territory has to be enumerated country by country, and several countries have to be excluded outright rather than optimistically included. Our piece on when a multi-country distributor makes sense makes the general argument; this is the sharpest European example of it.

The second is that this is a moving target. A revised Directive is in development, intended to bring pouches and related products into a European framework, but harmonisation is not expected before 2027 at the earliest and the detail is unsettled. Any territory definition written today should assume the rules will change within the term of the agreement, and should say what happens when they do.

5. Three failures, three different shapes

Set side by side, these are not three versions of the same problem. They fail at different points, which is why a single compliance question does not catch all three.

Put another way: one is a question about what the product is, one about who owns the right to sell it, and one about where the border actually falls. A brief that covers only the first will miss the other two, and most briefs cover none of them, because all three sit outside the commercial frame in which a distribution decision is usually made.

6. Testing a product before you look for a partner

This does not require a regulatory department. It requires four questions asked in the right order, before money is committed to a search.

7. What this means for a distributor search

We run distributor identification and selection, not regulatory affairs, and we are careful about the line. We are not a substitute for local regulatory or legal advice, and on any specific product you should take it.

But there is a version of this work that treats the brief as given and simply returns the best available partners, and a version that asks what the product is before asking who could sell it. The first is faster and occasionally produces an excellent shortlist for a deal that cannot happen. The second sometimes ends with us telling a prospective client that the project as described does not work — which is a worse outcome for us in the short term and the only defensible one.

Where a regulatory constraint does exist, it usually reshapes the search rather than ending it:

• A formulation limit changes the channel. The whitening category still has a European market; it runs through dental professionals rather than retail, which is an entirely different partner profile and a search worth running on its own terms.
• A market-access holder requirement changes the qualifying criteria. “Can act as Responsible Person” and “will accept that we appoint an independent Responsible Person” are both screening questions, and they separate partners faster than most commercial criteria.
• A fragmented territory changes the structure. Enumerate the markets that are open, appoint properly in those, and take a time-limited option on the ones that may open later.

In each case the useful output is not a longer list. It is a shorter list of partners who can actually execute, and a clear statement of what has to be true for the deal to work at all.

General commercial guidance, not legal or regulatory advice. The positions described were researched against regulatory and institutional sources current in October 2026; the nicotine category in particular is changing quickly at national level and a European framework is under development. Requirements vary by product within a class and by country within a bloc. Take local regulatory and legal advice on any specific product and market before relying on any of this.