PCN enforcement: what the EU-wide inspection pilot found

For years, poison centre notification lived in an enforcement grey zone: a clear legal duty, but little public evidence that anyone checked. That ended on 11 February 2026, when ECHA published the results of the Enforcement Forum’s pilot project on PCN enforcement (news item ECHA/NR/26/08). For the first time there are EU-wide numbers on how many companies actually comply, who the non-compliant ones are, and what inspectors do about it. This article sets out those numbers precisely, adds the national penalty frameworks the report does not spell out, and separates the pilot from REF-14 — the larger enforcement project running through 2026.

The pilot in numbers

Between January and June 2025, inspectors in 18 EU/EEA countries — almost two-thirds of member states — checked 1,597 mixtures against the Article 45 and Annex VIII duties. The headline finding: 19% of the mixtures that required a poison centre notification had none. The rate is calculated on the 1,432 mixtures where a PCN was actually required, so it is not diluted by out-of-scope products — roughly one hazardous mixture in five, invisible to the poison centres that are supposed to answer emergency calls about it.

The second measure was the label itself: where a UFI was required on the label, it was missing in 15% of checked mixtures. That is the cheapest possible finding for an inspector — it takes seconds and no database access — and it often signals deeper problems, since a missing code correlates with a missing or unlinked dossier (the relationship between the two artefacts is unpacked in UFI vs PCN).

Two structural findings matter for reading the rest. First, 71% of inspected mixtures came from SMEs — this is an SME-shaped compliance problem largely because the EU mixture market is SME-shaped. Second, size was no predictor: the compliance rate was essentially identical for SMEs (59%) and large companies (58%). Bigger regulatory departments did not buy better outcomes; the failure mode is unawareness of a specific duty, not lack of resources.

Chris Van den hole, chair of the pilot’s working group, put the stakes plainly: “Missing notifications of the necessary information to the poison centres undermine the effectiveness of emergency response.” The quote continues — inspectors “take these findings very seriously and initiated numerous enforcement actions to bring companies to compliance.”

The 656 enforcement actions

Inspectors took measures in 656 reported non-compliant cases, scaled to severity:

Read this table both ways. The reassuring reading: 83% of measures were advice, written or verbal — a first finding is far more likely to produce a deadline than a penalty. The sober reading: in a six-month pilot never designed to punish, inspectors still issued 72 binding orders, 30 fines and put 29 files in front of prosecutors. The escalation path exists and was used. Advice is also not a free pass — it comes with rectification expected, and an ignored written advice is the classic route to the order and the fine.

What penalties look like nationally

CLP leaves penalties to member states, so the downside of the same missing notification varies by market. Three concrete frameworks:

• Germany (country guide): breaches of chemicals-law duties are administrative offences under § 26 of the Chemikaliengesetz, with fines up to €50,000in the statute’s top administrative tier (lesser infringements carry a lower ceiling).
• France (country guide): the Code de l’environnement provides administrative fines up to €15,000 plus a daily penalty of €1,500 until compliance (Art. L521-18), and a separate criminal track — up to two years’ imprisonment and €75,000 — for knowingly providing false information or withholding required data (Art. L521-21).
• Lithuania (country guide): the Code of Administrative Offences (ANK) Art. 308 fines the responsible individuals personally — €150–1,450 under Art. 308(5), rising to €340–4,300under Art. 308(16) — a reminder that in some states the name on the fine is a manager’s, not the company’s.

Set these numbers against the cost of just doing the work — a few hundred euro per mixture even at consultant rates, far less with tooling (see what a PCN costs) — and the risk-reward of ignoring the duty collapses. A single French daily penalty outruns the cost of notifying a whole product line within weeks.

REF-14: the separate, ongoing 2026 project

The pilot is finished; enforcement is not. REF-14is the Enforcement Forum’s next coordinated project — a distinct and larger exercise, prepared with inspector training through the end of 2025, with inspections running through 2026and a report expected in 2027. Its scope is broader than the pilot’s: classification, labelling and packaging of mixtures (including child-resistant fastenings), poison centre notifications, and safety data sheets of hazardous mixtures in consumer products — plus checks under REACH restrictions and the POPs Regulation.

Before an inspector calls

The pilot report doubles as a checklist of what gets found. Working through it proactively:

1. List every hazardous mixture on the market and confirm which require notification — the scope walk-through is in do I need to submit a PCN.
2. Reconcile labels against notifications: every required UFI on the label, every UFI backed by an accepted dossier covering the markets you actually sell in.
3. Close the gaps now. All deadlines have passed and the duty is continuous, so late notification is the only remaining option — and a far better look than discovery (see PCN deadlines for how to sequence a backlog).
4. Keep proof. Submission numbers, acknowledgements and dates, retrievable in minutes — the difference between a five-minute inspection and a written advice letter.

The pilot’s quiet lesson is that most non-compliance was not defiance but ignorance of a specific, checkable duty — and that inspectors respond accordingly, once. Companies that fix the gap before the second knock rarely appear in the fines column. If the obstacle is the hours per dossier rather than the will, that is the part Ufi Number automates: dossier, submission and the acknowledgement number that answers an inspector’s first question, at €20 per mixture.