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

Yes, if the mixture is classified for a health or physical hazard and you’re the one placing it on the EU/EEA market. That’s the short answer. The longer one, the one you need for a real product list, is what “classified”, “placing on the market” and the handful of exemptions 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.

The scope decision is only as good as the classification behind it. No notification tool, UFI Number included, classifies a mixture for you. If a product’s classification is wrong, the answer this page gives you is 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.

Annex VIII isn’t the whole map either. A few member states run national schemes with wider nets: Germany and Italy, for example, require all detergents to be notified regardless of classification. Check each market in our country-by-country guide.

Voluntary notification: allowed, sometimes useful

Mixtures outside the mandatory scope can still be notified voluntarily. The reasons are practical. A retail or tender customer asks for UFIs across the whole range and doesn’t distinguish mandatory from exempt lines. One process for the whole portfolio can be simpler than a scope spreadsheet with a justification per SKU. And a borderline product that drifts in and out of scope with each reformulation stops needing re-assessment once it’s notified.

A voluntary notification isn’t a lighter notification. It follows the same harmonised format, and once it’s in the poison centres’ database it has to 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 case that gets missed is an ordinary one: buying a finished mixture from an EU supplier and selling it under your own brand. It’s an understandable reading, because the supplier has already notified, so the product looks covered. The regulation reads it differently. The moment your name goes on the label, you’re 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. It doesn’t replace your submission.

A decision sequence you can apply

Run each product on your list through these questions, in order. 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 to notify, the work from there is the UFI, the notification in the current PCN format, the submission and the submission number to file. You can do all of it in ECHA’s portal, and it’s free. UFI Number is built for the same steps when they come back product after product. It’s in private beta.