A US company recently asked me a simple question:
“If our US company submits the PCN notification, does that solve the EU requirement?”
It sounds logical, doesn’t it?
But unfortunately, that’s not how EU chemical legislation works.
This misunderstanding is very common among non‑EU companies selling products on Amazon in Europe. A recent exchange with a brand owner illustrates why. To understand why, we need to step back for a second and start at the basics.
First: what PCN actually means
PCN stands for Poison Centre Notification.
Under the EU CLP Regulation, companies placing hazardous mixtures on the market must submit specific information about those mixtures to poison centres. This allows medical professionals to respond quickly if someone is exposed to a chemical product.
The notification includes information such as:
· the exact composition of the mixture
· toxicological information
· the product category
· and a Unique Formula Identifier (UFI)
The key point here is simple:
The legal responsibility lies with the company placing the mixture on the EU market.
And this is the part many non‑EU companies are having trouble understanding.
Many manufacturers outside the EU assume they can submit the PCN themselves and solve the requirement for everyone involved.
However, EU law defines responsibilities differently. Let me explain.
If your company is based outside the EU, you are not considered the importer. The importer is the EU‑based company that brings the product into the European market.
And under the CLP Regulation, the importer must submit the PCN notification. Yes, even if:
· the manufacturer is outside the EU;
· the manufacturer is fully transparent about the formulation;
· the manufacturer has already created a UFI.
The importer still has their own legal obligation.
So why do voluntary PCN submissions exist?
There is still a useful option available for non‑EU companies: voluntary PCN submission.
This option is often used when a manufacturer wants to protect the full formulation of a product.
For example, a manufacturer may supply the same mixture to several EU importers.
Instead of revealing the full composition to every importer, the manufacturer can:
1. create a voluntary PCN submission
2. generate a UFI
3. share that UFI with importers
The importers then submit their own PCN notifications using that UFI. In this way:
· poison centres receive the necessary information;
· importers fulfil their legal obligations;
· manufacturers can protect confidential formulations.
Another important detail: the Safety Data Sheet
During the same discussion, another common question came up:
“Can the Safety Data Sheet simply show our US company as the supplier?”
For products placed on the EU market, the Safety Data Sheet must include an EU‑based supplier. This means the SDS must list:
· an EU manufacturer,
· EU importer, or
· EU distributor.
A Safety Data Sheet that lists only a US company will generally not meet EU compliance expectations.
What Amazon sellers should check early
If you are a non‑EU company selling products through Amazon in the EU, it is worth clarifying a few things early.
Before placing products on the market, make sure you know:
1. Who is the legal importer in the EU?
2. Who will submit the PCN notification?
3. Does the Safety Data Sheet include an EU supplier and is made according EU Regulation (REACH)?
4. Do your products already have a UFI?
Many companies only discover these requirements when Amazon requests compliance documentation, or a distributor asks for regulatory confirmation.
At that point, things often become urgent.
The practical takeaway
Voluntary PCN can protect your formulation, but it cannot replace the importer’s legal obligation.
Chemical regulations are challenging, time-consuming and they can cost you money and, worst of all, have a hard-earned reputation. If you need help with them, you can write to ma at simona.miklavcic@bens-consulting.eu.
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