How to submit a PCN: the full process, step by step
The PCN submission process end to end: confirming the duty, gathering data, choosing between IUCLID Cloud, IUCLID 6 and S2S, and reading the submission report.
Published
Submitting a poison centre notification (PCN) is a defined, repeatable process: confirm you are in scope, assemble a specific data set, build a dossier in ECHA’s current PCN format, submit it through one of three routes, and read the submission report that comes back. None of it requires a consultant — ECHA charges nothing at any step — but each stage has a failure mode that costs real time if you meet it unprepared. This guide walks the whole path.
Step 1: confirm the duty and the scope
The duty falls on importers and downstream users placing mixtures classified for health or physical hazards on the EU/EEA market — environmental-only classifications are out of scope. All compliance dates have passed (consumer and professional use since 1 January 2021, industrial use since 1 January 2024, the last transition ended 1 January 2025), so the obligation is continuous: notify before the product ships, for every mixture in scope. If you are unsure whether that includes you — rebranders, re-importers and toll manufacturers are the usual edge cases — work through do I need to submit a PCN first.
Step 2: gather the data set
This is the longest step, and almost all of the effort. A PCN needs your submitter identity, the product’s trade names, a UFI, a EuPCS product category, the full composition with exact concentrations or permitted ranges, toxicological information, the CLP classification and label elements, packaging types and sizes, use type, colour, physical state and pH. The complete field-by- field breakdown — including the tighter concentration rules for components of major concern — is in PCN required information. Expect the composition detail to exceed what your SDS contains: section 3.2 of an SDS only lists hazardous components above cut-offs, while a standard PCN wants the whole recipe.
Step 3: choose a submission route
ECHA provides three routes, all free, all producing the same notification:
- ECHA Submission portal with IUCLID Cloud. Everything in the browser: you prepare the dossier online and submit in the same session. The default for SMEs with up to a few dozen mixtures a year.
- IUCLID 6 desktop, then portal upload.You prepare dossiers offline in ECHA’s IUCLID 6 application, export a .i6z dossier file, and upload it to the portal. Fits teams that want local control of data, or that reuse substance datasets across many products.
- System-to-system (S2S).Software builds and submits dossiers directly against ECHA’s API using ECHA-issued S2S keys — no portal clicks at all. This is the route high-volume notifiers and platforms use; it is also how Ufi Number submits on its customers’ behalf.
A fuller decision framework, including group submissions, is in PCN submission options compared.
Step 4: prepare the dossier
Whichever route you choose, the deliverable is the same: a dossier in the current PCN format (v8 since April 2026). You enter substances and their concentrations, link them into a mixture composition, attach the product, packaging and toxicological records, and set the dossier header — including the submission type and, for industrial-only mixtures using the lighter option, the limited-submission flag.
Before submitting, run the built-in validation assistant. The PCN checks run to 130+ business rules in two severities: BR rules block submission, QLT rules warn but let the dossier through — and some member states follow up on ignored warnings. Fixing failures at this stage is cheap; discovering them after a rejected submission is not. Common failures and their fixes are catalogued in PCN validation errors.
Step 5: submit — and get the member-state selection right
At submission you declare the market area: every member state where the mixture will be placed on the market. This selection matters more than it looks. It drives which national requirements bite — language of the submission, national fees (Belgium’s annual tiered fee, fees in Hungary, Italy’s €50 per registrant per year) — and it cannot simply be “everything, to be safe”: each selected country may impose its own conditions. Under-selecting is worse: selling in a country you never notified for is a straightforward breach.
Step 6: read the submission report
After submission the portal returns a report. Read all three parts of it:
- Validation outcome. A pass means the dossier cleared the business rules; any QLT warnings are listed and worth resolving in your next update.
- Submission number. This is your compliance evidence and the reference for every future update or authority query. File it with the product record.
- Per-country reception. The report shows the delivery status for each notified market. For the six confirmation-of-receipt countries, this is the line that determines when you may start selling there.
A successful submission is not an approval — member states do not “accept” PCNs — but a failed or partially received one is a blocked market entry, so treat the report as a gate, not a receipt to file unread.
Step 7: retain records and keep the notification current
Keep the submission report, the dossier snapshot and the underlying data together, per product, for as long as the product is on the market. The notification is a living record: composition changes beyond permitted ranges, a new EuPCS classification, changed hazard classification or new markets all trigger an update — see how to update a PCN. Updates must be made in the format current at the time of the update, which is one of the quiet ongoing costs of doing this in-house: the format moves roughly once a year.
For a one-product company, the whole cycle above is a few days of learning and an afternoon of work. If you notify tens of mixtures a year, the assembly and re-validation loop is exactly the part worth automating — that, not the €0 ECHA fee, is where the cost of PCN compliance actually sits.
Frequently asked questions
How much does it cost to submit a PCN?
ECHA charges nothing: the Submission portal, IUCLID Cloud and S2S access are all free. National fees exist in only three countries — Belgium (annual tiered fee), Hungary (fees set by the appointed body) and Italy (€50 per registrant per year). The real cost of a PCN is the time spent assembling composition and toxicological data.
Where do I submit a poison centre notification?
Through the ECHA Submission portal, which is the central entry point for nearly all EU/EEA markets. You can prepare the dossier online in IUCLID Cloud, upload a .i6z file prepared in IUCLID 6, or have software submit system-to-system via ECHA’s S2S gateway.
Do I need to wait for approval before selling?
There is no approval step — member states do not accept or reject valid notifications. However, in Belgium, France, Germany, Italy, Luxembourg and Spain the notification must show as received by the national body before you place the mixture on that market, so check the per-country status in your submission report.
Can one PCN cover several countries?
Yes. A single notification declares a market area covering every member state where the mixture is sold. Each selected state applies its own language requirements and any national fee, so the selection should match your actual markets — neither padded nor missing any.
What is the submission number for?
It is the unique reference ECHA assigns to your notification and your primary compliance evidence. You will need it for every update, for authority correspondence, and to demonstrate compliance during an inspection, so file it with the product record.
Sources
- Prepare and submit a PCN — ECHA, accessed July 2026.
- Prepare your submission — the three routes — ECHA, accessed July 2026.
- Member States Decisions overview (MSD) — ECHA, v14, May 2026.
- PCN format — annexed validation rules — ECHA, accessed July 2026.
Related guides
- PCN required information: the complete data checklistThe full checklist of what a poison centre notification must contain, from submitter identity to market area, and what a limited submission drops.Read the guide
- PCN submission options compared: portal, consultant, suite or focused toolAn honest comparison of the four ways to submit a poison centre notification: ECHA’s free portal, a consultant, an enterprise EHS suite or a focused tool.Read the guide
- What is an i6z file? The IUCLID PCN dossier, demystifiedWhat a IUCLID .i6z dossier file is: what’s inside the archive, how one gets built, how to inspect one safely, and why you never hand-edit it.Read the guide