Do I need to submit a PCN? A decision guide to scope and exemptions

If your company places chemical mixtures on the EU or EEA market, the question “do we need to submit a poison centre notification?” has a short answer: yes, if the mixture is classified as hazardous for health or physical effects, and you are the one placing it on the market. The longer answer — the one you need to apply that rule to a real product list — is working out what “classified”, “placing on the market” and the handful of exemptions actually mean for each SKU.

The duty comes from Article 45 of the CLP Regulation ((EC) No 1272/2008) and its Annex VIII, and it attaches per mixture and per member state where the product is sold. What the notification itself contains is covered in our guide to the poison centre notification; this page is only about the decision that comes first.

The trigger is classification, nothing else

Whether you owe a notification is decided by your mixture’s CLP classification — not by sales volume, not by sales channel, not by whether the customer is a consumer or a factory. If the classification includes at least one health hazard class (acute toxicity, skin corrosion or irritation, serious eye damage, sensitisation, STOT, carcinogenicity and the rest) or at least one physical hazard class (flammable liquids, oxidisers, corrosive to metals and so on), the mixture is in scope. The fastest place to check is section 2 of your own safety data sheet.

Use type — consumer, professional or industrial — once determined when the duty started, but all three phase-in dates have now passed (the last on 1 January 2024, with the final transition ending 1 January 2025 — see PCN deadlines). Use type still affects what you submit, because industrial-only mixtures qualify for a limited submission; the differences are set out in consumer, professional and industrial use.

One honest caveat: the scope decision is only as good as the classification behind it. No notification tool — Ufi Number included — performs CLP classification for you. If a product’s classification is wrong, the answer this page gives you will be wrong with it.

What is out of scope

The exemptions are narrow and specific:

• Environmental-only classification. A mixture classified solely for environmental hazards — hazardous to the aquatic environment and nothing else — carries no notification duty.
• Gases under pressure. Mixtures whose only classification is as gases under pressure are exempt.
• Certain explosives. Unstable explosives and explosives of Divisions 1.1 to 1.6 are exempt.
• Scientific research and development.Mixtures used in scientific R&D that are not placed on the market fall outside the duty entirely.
• Products outside CLP altogether. Medicinal and veterinary products, cosmetics, medical devices and food or feed in their end-use state are governed by their own frameworks and never reach Annex VIII.

Read the first three exemptions with the word only in mind. A degreaser classified for aquatic toxicity and skin irritation is in scope — the environmental exemption applies solely when no health or physical hazard class is present. The same logic applies to gases under pressure: an aerosol that is also classified as a flammable aerosol does not escape.

Also note that Annex VIII is not the whole map. A few member states keep national schemes with wider nets — Germany and Italy, for example, require all detergents to be notified regardless of classification. Check the rules for each market in our country-by-country guide.

Voluntary notification: allowed, sometimes useful

Mixtures outside the mandatory scope can still be notified voluntarily. Why would anyone volunteer? Three practical reasons come up. Large retail and tender customers increasingly ask for UFIs across an entire range and do not distinguish between mandatory and exempt lines. Running one process for the whole portfolio is often cheaper than maintaining a scope spreadsheet with per-SKU justifications. And for borderline products that drift in and out of scope with each reformulation, notifying once removes the re-assessment cycle.

The caution: a voluntary notification is not a lighter notification. It must follow the same harmonised format, and once it is in the poison centres’ database it should be kept as current as any mandatory record — an outdated composition on file misleads exactly the people the system exists to inform.

The private-label trap

The most commonly missed case is not an exotic formulation — it is buying a finished mixture from an EU supplier and selling it under your own brand. The intuition says the supplier already notified, so the product is covered. The regulation says otherwise: the moment your name and branding go on the label, you are placing the mixture on the market as a duty holder, and you need your own notification — normally with your own UFI. The supplier’s UFI can still do useful work inside your dossier as a mixture-in-mixture component, sparing you the fight for their full formula, but it does not replace your submission.

A decision sequence you can apply

Run each product on your list through these questions, in order. The sequence is designed so you can stop at the first “no”.

1. Is it a mixture? Pure substances and articles are outside Annex VIII (substances have their own regimes under REACH and CLP).
2. Do you place it on the EU/EEA market? Production purely for export outside the EU/EEA does not trigger the duty.
3. Is the product inside CLP scope at all? If it reaches the user as a medicine, cosmetic, medical device or food, stop here.
4. Does the CLP classification include any health or physical hazard? Check SDS section 2. No qualifying hazard class, no duty — though voluntary notification remains open.
5. Does a narrow exemption apply?Environmental-only, gases under pressure only, the listed explosives, or R&D material never placed on the market.
6. Are you the duty holder for this product?Importer, formulator, or re-brander — if you merely distribute another company’s product unchanged, the duty sits upstream. The full role-by-role breakdown is in who must submit a PCN.
7. If you got this far: notify before placing on the market. One notification covering every member state where the product is sold, and a UFI on the label that matches it.

Two habits make the exercise stick. First, run it per SKU, not per product family — variants with different fragrances or concentrations can classify differently. Second, record the answer and the classification version it was based on, because reformulation and classification updates reopen the question.

If the audit ends with a list of mixtures that need notifying, the mechanics — UFI generation, dossier building in the current PCN format, submission and the acknowledgement to file — are what Ufi Number automates at €20 per mixture. ECHA’s own portal handles the same steps for free; the difference is the time you spend inside it.