Label

UFI code and poison centre notification: a guide for exporters and importers

CLP Article 45 and Annex VIII: who notifies, compliance dates by use, the 16-character UFI on the label, update triggers, and the GB and Northern Ireland rules.

Updated: 8 min read

Contents
  1. Who carries the obligation
  2. Compliance dates by intended use
  3. What the UFI is and how it is made
  4. Preparing and submitting the notification
  5. When a new notification or a new UFI is needed
  6. Great Britain and Northern Ireland
  7. Checklist for exporters
  8. Frequently asked questions
  9. Sources

In short: A hazardous mixture placed on the EU market needs a poison centre notification (PCN) under CLP Article 45 and Annex VIII, and its label must carry a 16-character Unique Formula Identifier (UFI) that links the product to that notification. The duty sits with the EU importer or downstream user, not with the non-EU manufacturer, and from 1 January 2027 certain distributors join them. Great Britain has no Annex VIII: notifying the National Poisons Information Service (NPIS) is voluntary there, while Northern Ireland still follows the EU rules.

Who carries the obligation

Article 45 requires each Member State to appoint a body that receives "harmonised information relating to emergency health response and preventative measures, in accordance with Annex VIII". Annex VIII Part A, Section 3.1 then places the submission duty on the submitters: importers and downstream users who place on the market mixtures "classified as hazardous on the basis of their health or physical effects". Mixtures classified only for environmental hazards are outside the scope, and so are mixtures classified only as gases under pressure or as explosives (Section 2.2).

For an exporter outside the EU this has a practical consequence. The legal duty belongs to the EU company that first places the mixture on the EU market, usually your importer. You cannot discharge that duty for them, but you hold the information they need: the full composition, the classification of each component and Section 11 toxicology data. In practice exporters either share the composition with the importer under a confidentiality agreement, or supply a ready UFI and enough data for the importer to file the notification. Either way, the label you print must carry a UFI that matches a notification someone in the EU has actually submitted.

Regulation (EU) 2024/2865, the CLP revision, adds a new paragraph 1c to Article 45: distributors must also submit when they distribute a hazardous mixture in other Member States or when they rebrand or relabel it, unless they can show that the appointed body already received the same information. Under Article 2(3) of that regulation, as amended by the "stop-the-clock" Regulation (EU) 2025/2439, this applies from 1 January 2027. If your EU partner rebrands your product, ask now who will notify.

Compliance dates by intended use

Annex VIII was phased in by end use. The dates in Part A, Section 1 are all in the past, so every in-scope mixture should already be covered:

Use category (Annex VIII Part A, 2.4)Comply fromNotes
Consumer use1 January 2021Full submission; UFI on the label
Professional use (not at industrial sites)1 January 2021Full submission; UFI on the label
Industrial use only, or end use not subject to notification1 January 2024Limited submission allowed if rapid access to detailed product information is available (Section 2.3); UFI may be given in the SDS instead of the label (Section 5.3)
Mixtures notified under older national systemsUntil 1 January 2025Transitional period of Section 1.4 has ended; a changed mixture had to comply earlier (Section 1.5)

Where a mixture has more than one use, the requirements for every relevant category apply.

What the UFI is and how it is made

Section 5.1 of Part A defines the UFI as "a unique alphanumeric code that unambiguously links the submitted information on the composition of a mixture" to that mixture or group of mixtures. It is generated free of charge with ECHA's UFI Generator. According to ECHA's UFI Generator user guide, the code has 16 upper-case alphanumeric characters, built from the company's VAT number (optional but recommended) and an internal formulation number, with the last character serving as a checksum.

On the label the code appears as UFI: followed by the 16 characters, "clearly visible, legible and indelibly marked" (Section 5.2). Article 25(7) puts it in the supplemental information on the label. Section 5.3 allows alternatives:

  • on the inner packaging next to the other label elements;
  • on the outer packaging, if the inner packaging is too small or awkwardly shaped;
  • in the SDS, for unpackaged mixtures or for packaged mixtures supplied for use at an industrial site.

Under REACH Annex II as amended by Regulation (EU) 2020/878, a UFI that is shown on the SDS goes into subsection 1.1. See the 16 SDS sections explained for the rest of Section 1.

Preparing and submitting the notification

The submission follows Annex VIII Part B. It must be made electronically in the XML format provided by ECHA (Part A, Section 3.1) and in the official language(s) of each Member State where the mixture is placed on the market, unless that Member State provides otherwise (Section 3.3). The intended use is described with ECHA's harmonised product categorisation system, the EuPCS (Section 3.4). A notification contains, in outline:

  • product identification, including trade names, the UFI and contact details of the submitter;
  • hazard identification: classification, label elements and toxicological information;
  • the composition, with concentrations or ranges as set out in Part B, Section 3.4;
  • for each component, its classification for health and physical hazards (Section 3.8);
  • where a component is itself a mixture (a "mixture in mixture"), either its own UFI or the supplier's SDS composition and contact details.

ECHA maintains a Union-level poison centres notification portal, and Article 45(1a), inserted by Regulation 2024/2865, lets Member States appoint ECHA itself as the receiving body. Confirm with the appointed body of each target country how it accepts submissions and whether it charges a fee before you rely on a single filing. The composition data must match the classification of the mixture. Our guide to mixture classification under CLP shows how the summation method produces that classification.

When a new notification or a new UFI is needed

Part B, Section 4.1 requires a submission update before the changed mixture is placed on the market when:

  • the product identifier or the UFI changes;
  • the classification for health or physical hazards changes;
  • relevant new toxicological information required in SDS Section 11 becomes available;
  • a component that must be reported is added, substituted or removed, or a concentration moves outside the reported range or beyond the tolerance in Table 4 (for example ±5 % for a component above 25 %).

Composition changes of the last type also require a new UFI (Part A, Section 5.1), with narrow exceptions for perfume changes in group submissions and for interchangeable component groups. Link formulation change control to label artwork. Our free label tool shows where the UFI sits among the other label elements.

Great Britain and Northern Ireland

GB CLP does not contain Annex VIII. GOV.UK guidance on NPIS states that there is "no obligation to generate or submit a unique formula identifier (UFI) code in Great Britain". GB importers and downstream users are encouraged to send information voluntarily, as a safety data sheet e-mailed to NPIS, and NPIS will register an existing UFI with the product.

Northern Ireland is different. EU CLP continues to apply there under the Windsor Framework, so Annex VIII applies in full. Because NPIS has no access to ECHA's notification tools, the same guidance says submissions for Northern Ireland "must be provided in the form of a PCN" and sent directly to NPIS Birmingham as the appointed body. For the wider differences between the markets, see SDS requirements in the EU, UK and US.

Checklist for exporters

  1. Confirm whether the mixture is classified for a health or physical hazard. If it is, Annex VIII applies.
  2. Agree in writing who submits in each Member State: the importer, a downstream user, or, from 2027, a distributor that rebrands.
  3. Generate the UFI before the label is finalised and keep a register of UFI, formulation number and label version.
  4. Provide complete composition data, including the components of any "mixture in mixture".
  5. Review every formulation change against Part B, Section 4.1 before production.
  6. For Northern Ireland, plan a PCN to NPIS; for Great Britain, decide whether to send an SDS voluntarily.

Frequently asked questions

Can a company outside the EU submit the poison centre notification itself?

The legal obligation rests on the EU importer, downstream user or, from 1 January 2027 in certain cases, distributor. A non-EU manufacturer supports that company with data and the UFI, but it does not take over the EU company's legal responsibility.

Does every hazardous mixture need a UFI?

Mixtures classified for health or physical hazards and within the scope of Annex VIII do. Mixtures classified only for environmental hazards, only as gases under pressure or only as explosives, and research and development mixtures, are outside the scope.

Is a UFI required on labels in Great Britain?

No. GB has no Annex VIII and no UFI duty. A UFI already printed on a label for the EU can stay, and NPIS will register it if you send them the SDS.

This article summarises legal texts for orientation only; it is not legal advice. Check the current consolidated text and the appointed body of each Member State before relying on it.

Sources

  • CLP, Regulation (EC) No 1272/2008, Article 25(7), Article 45 and Annex VIII (consolidated text) — CELEX:02008R1272.
  • Commission Regulation (EU) 2017/542 adding Annex VIII to CLP — CELEX:32017R0542.
  • Regulation (EU) 2024/2865 amending CLP, Article 1(24) and Article 2 — CELEX:32024R2865.
  • Regulation (EU) 2025/2439 amending the application dates of Regulation 2024/2865 — CELEX:32025R2439.
  • ECHA, UFI Generator application user guide — poisoncentres.echa.europa.eu.
  • GOV.UK, Submitting chemicals information to the National Poisons Information Service — gov.uk.

Related codes

H and P statements related to this topic; each is explained in the glossary with its full wording, thresholds and label use.

Related articles