PCN scope — which mixtures must be notified

The scope test in Annex VIII is narrower than it first looks, and it turns on two things: what the product is — a mixture, not a single substance — and what it is classified for under CLP. Both conditions have to hold before a PCN dossier is required at all.

Mixtures classified for health or physical hazards

The obligation applies to a mixture placed on the EU market that is classified for a health hazard or a physical hazard under CLP — categories such as acute toxicity, skin corrosion or irritation, serious eye damage or irritation, sensitisation, specific target organ toxicity, aspiration hazard, or physical hazards like flammability or corrosivity to metals. If the mixture's classification touches one of these hazard classes, at any category, a PCN dossier is required before it is placed on the market, regardless of how small the company selling it is or how limited its distribution.

Classification drives the obligation, not intended use, brand size, or how the product is marketed. A mixture with a hazard classification does not become exempt because it is sold in small volumes, through a single retailer, or under a private label rather than the manufacturer's own name.

What is outside Annex VIII

A mixture classified only for an environmental hazard — with no health or physical hazard classification alongside it — falls outside Annex VIII entirely. The regulation was built around emergency response to human exposure, and a purely environmental classification does not trigger that scenario, so it does not trigger the notification duty either.

Several other product categories sit outside Annex VIII regardless of classification, because they are already covered by their own regulatory regime with its own reporting channel to poison centres or an equivalent body:

• Medicinal products for human or veterinary use, regulated under separate pharmaceutical legislation.
• Cosmetic products, which report through the Cosmetic Products Notification Portal instead.
• Food and feed, including additives, which fall under food and feed law rather than CLP.
• Medical devices, covered by their own device regulation.
• Radioactive mixtures, subject to radiation protection legislation.
• Mixtures for scientific research and development that are not placed on the market as a product in their own right.

None of these exclusions depend on hazard classification — a cosmetic product with an irritant classification is still out of scope for a PCN, because the exclusion is about which regulatory channel applies, not about how hazardous the product is.

Industrial use mixtures and limited submission

Mixtures supplied exclusively for industrial use are inside Annex VIII's scope — the 1 January 2024 deadline brought them in on the same basis as consumer and professional mixtures — but Annex VIII gives this category one option the others do not have. Instead of the full composition and toxicological data set, a notifier can file a limited submission built from the information already in the safety data sheet, provided the dossier also names a contact who can supply the complete composition to a poison centre at any hour if an incident occurs.

Limited submission is a lighter route through the same obligation, not an exemption from it. A mixture using it still needs a UFI, still needs a dossier on file before it reaches the market, and still needs that dossier updated when the composition or classification changes — the reduced data set is the only thing that differs. If your product's use profile changes, from purely industrial to something a consumer could also buy, the limited submission basis no longer applies and a full dossier is needed instead.

Substances are not mixtures

Annex VIII applies to mixtures. A single substance placed on the market on its own — not combined with anything else — is outside its scope entirely, no matter how hazardous that substance is classified. This is a common point of confusion, because CLP itself covers substances and mixtures together, and companies used to thinking in CLP terms sometimes assume the notification duty follows the same pattern. It does not: there is no PCN dossier, and no UFI, for a neat substance.

The distinction that matters in practice is where a substance stops being sold on its own and starts being one component of something else. A solvent sold as itself needs no notification. The moment that same solvent is blended with even one other ingredient — a stabiliser, a colourant, a second solvent — the result is a mixture, and if it carries a health or physical hazard classification, Annex VIII applies to it from that point. Repackaging or diluting a substance with only water, where the classification and composition otherwise stay identical, is a case worth checking carefully rather than assuming either way, since the answer depends on the specifics of what changed.