How to update a poison centre notification
Update vs new notification, the update reasons in the PCN format, the timing rules, and why every update must pass the current format's validation.
Published
A poison centre notification is not a filing you make once. Products get new trade names, enter new markets, change classification, gain new toxicology data, get withdrawn, come back. Annex VIII to CLP obliges you to keep the submitted record aligned with the product on the shelf — and the PCN system distinguishes sharply between an update of an existing notification and a new notification after a significant change of composition. Choosing the wrong one breaks the record chain that appointed bodies rely on.
Update or new notification?
The dividing line is the composition. If the mixture’s composition is unchanged — or has moved only within the declared ranges and tolerances — you submit an update: a revised version of the dossier under the same PCN number, with the update flag set and a reason selected. If the composition changed beyond the Annex VIII limits, the product is legally a different mixture. You then submit a new notification after a significant change of composition, carrying a new UFI; the system generates a new PCN number and stores the old one on the record as a related identifier, so the lineage survives. Both the old and new records stay live, because product with the old UFI may remain on the market for years.
From your side both look like “updating the notification”. From the poison centre’s side they are opposites: an update replaces or extends information about one mixture; a composition change creates a second mixture whose record must coexist with the first.
The update reasons in the PCN format
An update dossier must declare why it exists. The format provides a fixed justification list — the wording below is the picklist in ECHA’s Guide to the PCN format — plus a free-text “other update reason” for anything the list misses:
| Update reason | Typical scenario |
|---|---|
| Change in mixture composition without requiring a new UFI | Exact concentration revised within the Table 4 tolerance; component swapped inside an interchangeable component group |
| Change in the mixture classification | Reclassification after new data or revised CLP criteria |
| New toxicological information available | New study results feeding Section 11 of the SDS |
| Change in the product identifier | Product renamed; voluntary UFI change on a rebrand |
| Correction/deletion of trade name | Fixing a misspelled name; retiring a discontinued variant name |
| Correction of error | Wrong EuPCS category, packaging entry or contact detail in the original dossier |
| Expansion of market area | Entering additional member states with the same product |
| Cease product from market | Withdrawal from one or all notified markets |
| Re-place product on market | Reintroducing a previously ceased product |
Two frequent cases ride on this list rather than appearing in it by name. A new trade name for a product still sold under the old one is an additionof information — both names stay valid, since stock with either label may be in circulation. And changes that Annex VIII does not enumerate but that matter for emergency response — a new packaging type or size, a changed product category, updated submitter contact details, revised component classifications — are updates too, per Section 7.4.3 of ECHA’s guidance, typically filed as a correction or with the free-text reason.
Timing rules
Annex VIII sets two clocks. For the changes listed in Part B Section 4.1 — the product identifier or UFI, the health or physical hazard classification, relevant new toxicological information, and any qualifying composition change — the update must be submitted before the mixture, as changed, is placed on the market. That is a hard sequencing rule: reformulated or reclassified product cannot legally ship ahead of its updated record. Part A Section 3.5 adds the general obligation to update without undue delay once the conditions are met — you cannot sit on a known change just because the changed product has not shipped yet.
For administrative changes outside the Section 4.1 list, the guidance applies the same logic: update as soon as the information changes, and in any event before changed product reaches the market. Ceasing a product has no statutory deadline, but the format expects market presence to be kept current — and a record that still claims eleven markets you exited complicates every later update and any inspection.
Updates and format versions
Updates are prepared and validated in the PCN format that is current when you submit the update, not the format you originally notified in. ECHA revises the format roughly annually with IUCLID releases — version 8 has been current since April 2026 — and each revision can add fields and tighten validation rules. The practical consequence: a dossier submitted under an older format can fail today’s validation the moment you touch it, for reasons unrelated to your change. A one-line trade-name correction can surface a missing field that did not exist when you first notified. Budget update work accordingly, and revalidate early rather than at the deadline.
A clean update workflow
- Classify the change. Composition beyond the declared limits → new UFI and new-composition notification. Anything else → update under the same PCN number. The triggers are enumerated in when does a UFI change.
- Start from the last submitted dossier, not from an internal draft — the update must be a revision of what the appointed bodies actually hold.
- Set the update flag and reason. Mark the dossier as an update and pick the justification from the list above; use the remarks field for anything the picklist cannot express.
- Revalidate against current rules.Expect the current format’s checks, including ones added since your original submission.
- Submit before the changed product ships, and archive the submission report with the change record — the confirmation, not the intention, is what closes the loop. The submission mechanics are the same as for an initial dossier; see how to submit a PCN.
Submitting updates through ECHA’s portal is free; only a few member states levy national fees on notifications. The cost of updates is almost entirely internal — tracking what changed, mapping it to the right mechanism, and re-passing validation in whatever format is current that quarter. That bookkeeping is precisely what Ufi Number automates: it keeps each mixture’s submission history, and dossier changes are built in the current required format rather than the one you happened to start with.
Frequently asked questions
When is an update enough and when do I need a new notification?
If the composition is unchanged — or changed within the declared ranges and tolerances — you submit an update under the same PCN number. If the composition changed beyond the Annex VIII limits, you submit a new notification after a significant change of composition, carrying a new UFI, and the system links it to the previous PCN number.
How quickly do I have to submit a PCN update?
For the changes listed in Annex VIII Part B Section 4.1 — composition, classification, product identifier, UFI, or relevant new toxicological information — the update must be submitted before the changed mixture is placed on the market. Part A Section 3.5 requires updates without undue delay once the conditions are met.
Do I have to update my PCN when I withdraw a product from the market?
The PCN format provides a dedicated update reason, cease product from market, and a matching re-place product on market reason if you bring it back. Keeping market presence current matters: appointed bodies use it, and stale records complicate later updates and inspections.
Does a PCN update cost anything?
Submitting through ECHA's portal is free, including updates. A few member states charge national fees on notifications — Belgium, Hungary and Italy as of the May 2026 member state overview — so check the markets you notify in.
Does an update have to use the latest PCN format?
Yes in effect. An update dossier is validated against the rules in force when you submit it — version 8 of the PCN format since April 2026 — not the rules from your original submission. Fields added since your first notification can therefore become mandatory the moment you update.
Sources
- Commission Delegated Regulation (EU) 2020/1677 — Annex VIII, Part B Section 4 — EUR-Lex, OJ L 379, 13 November 2020.
- Guide to the PCN format — ECHA, accessed July 2026.
- Poison centres notification format — ECHA, v8, April 2026.
- Guidance on Annex VIII to CLP — ECHA, v6.0, October 2025.
Related guides
- When does a UFI change? The composition triggers under Annex VIIIThe Annex VIII Part B 4.1 triggers that force a new UFI, the changes that do not, and how to keep formulation versions under control.Read the guide
- PCN format versions: v8, the annual cycle, and what changesPCN format v8 has been current since April 2026, replacing v7. What changes between versions, what it means for existing notifications, and how to stay current.Read the guide
- How to submit a PCN: the full process, step by stepThe PCN submission process end to end: confirming the duty, gathering data, choosing between IUCLID Cloud, IUCLID 6 and S2S, and reading the submission report.Read the guide