Our UFI and PCN services

Every engagement runs through the same stages, in the same order, whether the mixture is new to the market or has been sold for years without ever being notified. We do not hand off any of these partway through — the work carries through to submission, including acting on whatever validation feedback ECHA raises, not a set of files for your team to finish.

Composition review

We check the formulation against Annex VIII: which components have to be declared, which concentration range applies to each one, and where an exact percentage is required instead of a range. Most of the corrections we make at this stage are hazardous components a safety data sheet has left without a CAS or EC number attached. See composition disclosure and concentration ranges for how the ranges themselves work.

UFI assignment

Once the composition is settled, we generate the UFI, using your VAT number alongside a formulation number for that exact composition, and check it against any UFIs your company has already issued so the same formulation is never assigned twice. See how a UFI is created for the mechanics.

EuPCS categorisation

We select the European Product Categorisation System code the dossier needs, based on what the product is used for rather than what it contains. A category chosen for convenience rather than accuracy is one of the more common reasons a dossier passes validation but still gives a poison centre the wrong picture in an emergency — see EuPCS categorisation for the categories most often picked wrongly.

IUCLID dossier build and validation

All eight dossier sections are built in IUCLID 6, exported in the current PCN format, and run against ECHA's own validation rules before we submit anything. Errors are caught and fixed here, before submission, rather than after a rejection. See IUCLID 6 and the PCN format for what the validator checks.

Submission through the ECHA Submission Portal

We file the dossier through the Submission Portal to every member state your product reaches, and handle whatever that country adds on top of the harmonised data — a language requirement, a national fee, a different appointed body. See submitting through the ECHA Submission Portal for the portal side of this.

Updates and maintenance

A dossier is not a one-time filing. When a reformulation, a new trade name or a classification change puts your product outside what the dossier already declares, we update the existing filing rather than starting over, and track which of your dossiers is affected when a formulation changes. See when a PCN update is required for the specific triggers.

What we need from you

To start, we ask for:

• The current safety data sheet for the mixture
• The full composition, including components below the label threshold
• Your company's VAT number
• The trade name, and any UFI already on the label
• The member states the product is placed on the market in

Missing toxicological data or an incomplete composition does not stop us from starting — it is usually the first gap we flag back to you.

How long it takes

The timeline is set mostly by how complete the composition and toxicological information are when we receive them, and by how many member states the submission covers: a single-country filing with a clean safety data sheet moves faster than a group submission across several markets with a component still missing test data. We give a specific estimate once we have seen your safety data sheet, rather than quoting a fixed turnaround that would not hold for every mixture.