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PCN Obligation Tree

  1. Are you placing a substance or a mixture on the market?

    The PCN duty under Annex VIII applies to mixtures. A single substance on its own is outside its scope.

  2. Is the mixture placed on the EU or EEA market?

    Placing on the market means supplying or making available to a third party in the EU/EEA — including free samples.

  3. Is the mixture a finished medicine, veterinary product, cosmetic, medical device, or food/feed?

    Medicinal and veterinary products, cosmetics, medical devices, and food/feed in the finished state are outside CLP scope, so no PCN applies. Note: biocidal products and plant-protection products are not on this list — they stay in scope.

  4. Is the mixture used only for scientific research and development (SR&D) or PPORD?

    Annex VIII exempts mixtures used for scientific research and development and for product- and process-orientated research and development. The exemption ends once the mixture is otherwise placed on the market, including distributing samples.

  5. Is the mixture classified as hazardous for a health or physical hazard under CLP?

    Annex VIII is triggered by health or physical hazard classification. A mixture that is unclassified, or classified only for environmental hazards, is outside its scope. Check Section 2 of the SDS if unsure.

  6. Is the mixture classified ONLY for gases under pressure and/or explosives?

    Annex VIII does not apply to mixtures classified only for (1) gases under pressure, or (2) explosives (unstable explosives and Divisions 1.1–1.6). If the mixture also carries any other health or physical hazard, it stays in scope.

  7. What is the intended use category of the mixture?

    All three categories are now in force (consumer and professional since 1 January 2021, industrial since 1 January 2024; the transitional period ended 1 January 2025).

  8. Likely no notification duty

    No PCN duty for the substance itself

    Annex VIII applies to mixtures, so a single substance placed on the market on its own does not trigger a Poison Centre Notification. If you later place a hazardous mixture containing it on the market, assess that mixture separately.

    Basis: CLP Art. 45 + Annex VIII (mixtures)

  9. Likely no notification duty

    No PCN duty while it is not placed on the market

    The obligation is triggered by placing the mixture on the EU/EEA market. Revisit this before you supply it — including before sending samples — as the duty can arise at that point.

    Basis: CLP Annex VIII (placing on the market)

  10. Likely no notification duty

    Outside CLP scope — no PCN

    Finished medicines, veterinary products, cosmetics, medical devices, and food/feed are outside CLP scope, so Annex VIII does not apply. Your product's own regime still governs it.

    Basis: CLP Art. 1(5) product exclusions

  11. Likely no notification duty

    Exempt as SR&D / PPORD

    Mixtures used only for scientific R&D or PPORD are exempt from Annex VIII. Treat this as conditional: if the mixture is later placed on the market in any other way — including sample distribution — re-run this check.

    Basis: CLP Annex VIII (SR&D / PPORD exemption)

  12. Likely no notification duty

    No PCN duty on these hazards

    A mixture that is unclassified, or classified only for environmental hazards, is outside the Annex VIII trigger. If its classification changes to include a health or physical hazard, reassess.

    Basis: CLP Annex VIII §1.1 (health / physical hazards)

  13. Likely no notification duty

    No PCN duty — excluded hazard classes only

    A mixture classified only for gases under pressure and/or explosives (unstable explosives and Divisions 1.1–1.6) is expressly excluded from Annex VIII, so no Poison Centre Notification is due. If its classification later adds any other health or physical hazard, reassess — the exclusion no longer applies.

    Basis: CLP Annex VIII §2.2 (excluded hazard classes)

  14. Notification likely required

    A Poison Centre Notification is likely required

    A hazardous mixture for consumer or professional use placed on the EU/EEA market generally requires a PCN before it is placed on the market. A UFI must be generated and shown on the label.

    Generate one with our UFI Generator, then submit through the ECHA Poison Centres portal.

    Basis: CLP Art. 45 + Annex VIII (consumer / professional use)

  15. Notification likely required

    A PCN is likely required (industrial use)

    Industrial-use-only hazardous mixtures have required a PCN since 1 January 2024, with a UFIon the label. A reduced "limited submission" option can apply for industrial use — confirm the current conditions with ECHA.

    Create a UFI with our UFI Generator and check requirements on the ECHA Poison Centres portal.

    Basis: CLP Annex VIII (industrial use, in force 1 Jan 2024)

  16. Notification likely required

    A PCN is likely required (limited submission may apply)

    A mixture with an end use not subject to notification — one incorporated into a downstream mixture that is not itself notifiable — has been in scope of Annex VIII since 1 January 2024, so a Poison Centre Notification is generally required before it is placed on the market. A reduced "limited submission" option can apply to this category; confirm the current conditions with ECHA.

    A UFI is still required — generate one with our UFI Generator, then submit through the ECHA Poison Centres portal.

    Basis: CLP Annex VIII §1.3, §2.3 & §2.4(4) (end use not subject to notification; limited submission)

  17. Check with the authority

    Determine the CLP classification first

    Whether a PCN is required turns on the mixture's CLP classification. Establish it (Section 2 of the SDS is the usual starting point), then re-run this check. If it carries any health or physical hazard, a PCN is likely due.

    Basis: CLP Annex VIII §1.1 (classification-dependent)

  18. Check with the authority

    Check the specifics with ECHA

    Biocidal products and plant-protection products are generally not exempt — a PCN can be required in addition to their own regime — and distributor duties can differ. Because these carve-outs are fact-dependent, confirm your case against the ECHA Poison Centres guidance rather than relying on a yes/no here.

    Basis: CLP Annex VIII + ECHA guidance (regime-specific)

Reference only. Not legal or regulatory advice. Verify against the primary source before you act.

How it works

A Poison Centre Notification (PCN) is the harmonised submission of a hazardous mixture's composition and toxicological information to the appointed bodies (poison centres) in the EU/EEA, under CLP Annex VIII and Article 45. In an emergency, a poison centre uses it — retrieved via the UFI printed on the label — to advise on treatment.

The duty falls on the party placing the mixture on the market — typically the importer or a downstream user (such as a formulator or re-brander); distributors can also be caught in some cases, for example when they change the label or the language. Only mixtures classified for health or physical hazards are in scope; a UFI links the label to the submitted formulation, which is why the UFI Generator is the usual companion to this step.

This tree walks the main Annex VIII branches to indicate whether a PCN is likely due. It is guidance, not a legal determination — verify your case against the official ECHA Poison Centres guidance .

Worked example

A cleaning liquid classified Skin Corr. 1B (a health hazard), sold to consumers across the EU:

mixture → placed on the market → not a medicine/cosmetic/device/food → not SR&D → classified for a health hazard → consumer use. The tree lands on PCN likely required, with a UFI generated and shown on the label.

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last updated 2026-07-03