It usually starts with a message from your EU distributor.
Something like: “We need a UFI for your products before we can continue placing them on the market.” If you’ve never come across the term before, it can feel like it came out of nowhere. The pressure is real, the timelines are often short, and the first question is almost always: “Do we really have to disclose our full formulation?”
The short answer is: not necessarily.
This guide explains what UFI and PCN actually are, what role you play as a non-EU manufacturer, and how to handle it in a way that protects your confidential know-how.
What are UFI and PCN?
UFI stands for Unique Formula Identifier. This is a 16-character alphanumeric code that appears on the label (or sometimes the SDS) of certain hazardous mixtures sold in the EU.
PCN stands for Poison Centre Notification. It refers to the regulatory submission of product information to appointed bodies (poison centres) via ECHA's system, as required under Annex VIII to the CLP Regulation.
Think of it this way: the UFI is the key, and the PCN is the file it unlocks. When someone calls a poison centre after an incident involving your product, they use the UFI to immediately retrieve the composition and toxicological data they need to respond.
A PCN is generally required for mixtures classified as hazardous for health or physical effects — covering consumer, professional, and some industrial uses — placed on the EU market.
Can I just register the UFI myself?
This is one of the most common misconceptions. A non-EU manufacturer cannot simply “register the UFI in Europe.”
Under CLP Annex VIII, the legal duty to submit a PCN sits with the EU-based actor placing the mixture on the market. That's typically:
- The importer (an EU-based company bringing the mixture into the EU)
- A downstream user who is formulating or rebranding and placing the product on the market
- A distributor, in certain scenarios (e.g. if they place the product on the market under their own name)
If you're established outside the EU, you're not the legally valid "submitter" because you're not the entity placing the mixture on the EU market.
That said, you play a very important role. How well you support your EU partners often determines how smoothly this goes for everyone. They typically need an UFI to print on labels before placing products on the market, confidence that the product information is submission-ready, and clear documentation to submit across relevant member states.
What actually gets disclosed and to whom?
If your competitive advantage lies in your formulation, the idea of disclosing it to meet a regulatory requirement is genuinely uncomfortable. But it's important to distinguish between two very different types of disclosure:
- Public disclosure on the Safety Data Sheet or label, visible to the market
- Regulatory disclosure within a PCN submission, shared only with appointed bodies for medical purposes
A PCN submission contains detailed composition information that poison centres need for emergency health response. It is not published to the market. With the right approach — NDAs, controlled information flows, and careful PCN preparation — you can protect what matters while still meeting your obligations.
Two practical pathways for non-EU manufacturers
Non-EU manufacturers generally use one of two approaches. Which one fits depends on your supply chain structure, how many products are involved, and how many EU entities you work with.
Pathway A: Voluntary preparation of a UFI/PCN package
In this approach, you as the non-EU manufacturer work with a consultant to voluntarily prepare the data your EU partners will need: composition mapping, product categorisation, toxicological information, label elements, and UFI generation. Crucially, you do this without sharing your full formulation directly with your distributors.
This pathway is especially useful when:
- You have many similar mixtures and want a consistent, repeatable process
- Multiple EU distributors need the same underlying information
- You want to minimise what is shared widely and keep sensitive work under confidentiality controls
One important caveat: voluntary preparation is not the same as a legally valid PCN. The submission must ultimately be made by an EU-based entity. Think of it as a compliance enabler. It makes your EU partner's submission much easier, but it doesn't replace their legal duty.
Pathway B: Full PCN through your EU importer or distributor (recommended)
The most legally robust route is for the EU-based entity placing your product on the market to submit the PCN. To make this work, they need full composition details from you, however, this doesn't mean sharing everything uncontrolled with your distributor.
In practice, a consultant working with you can:
- Collect and validate full composition details from you under NDA
- Check classification and consistency with your SDS and label
- Prepare the PCN dossier(s) in the correct harmonised format
- Support your EU partner with submission in the ECHA PCN portal
- Set up a change management process so formulation or SDS updates are handled promptly
This approach puts responsibility where it legally belongs, while keeping you in control of your proprietary information. Your EU distributor receives what they need to submit, but the full formulation detail is handled through a trusted, confidential channel.
What you'll need to prepare and where SDSs typically fall short?
Here's a common assumption I hear over and over again: "Our SDS should cover it." In reality, PCN usually requires more precision than Section 3 of an SDS provides. Particularly for confidential ingredients. You'll typically need:
- Mixture identification: trade names, product codes, intended uses
- Full composition: all hazardous components with exact concentrations or PCN-accepted ranges
- Substance identifiers: CAS/EC numbers, or appropriate identifiers for UVCBs
- Classification and labelling: CLP classification, hazard and precautionary statements
- Product category: EuPCS categorisation (European Product Categorisation System)
- Toxicological information: aligned with SDS Section 11
- Packaging information: type and size ranges as required by Annex VIII
- UFI management: clear mapping between formulation, UFI, and market labels
Common SDS issues that create PCN delays include concentration ranges that are too broad, generic 'trade secret' entries with no mechanism to provide identity to the submitter, inconsistent CAS/EC identifiers, and classification misalignment between the SDS and the actual composition.
How confidentiality can work in practice?
Here's a scenario that illustrates how this can work. A manufacturer exporting multiple formulated mixtures to separate EU distributors provides full composition details to a single trusted consultant under NDA. That consultant:
- Creates a controlled “PCN-ready” dataset per formulation
- Ensures each EU partner receives only what they need to act as submitter
- Sets up a process so any formulation change triggers a review of whether a new UFI and updated PCN are needed
The result: the manufacturer never shares its full formulations directly with distributors, the EU partners can submit compliantly, and there's a clear process in place for the future.
Key takeaways
- UFI is not a standalone registration — it is linked to a PCN submission under CLP Annex VIII
- As a non-EU supplier, you are typically not the legally valid submitter, but you play a critical role in making compliance possible
- Trade secret concerns can be managed — through NDAs, controlled information flows, and structured preparation
- Your SDS is likely not enough on its own — PCN requires more detailed, more consistent composition data
- Starting early with a product inventory and formulation mapping avoids last-minute label changes, UFI rework, and repeated submissions
For companies supplying multiple mixtures into the EU, the most efficient approach is a coordinated programme: PCN readiness assessment, SDS alignment, UFI governance, and a repeatable submission workflow for each EU partner. Done well, it protects your confidential know-how and gives you a sustainable process for EU market access. If you'd like to talk through where your products stand, we're happy to help.
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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