The Blog

Previously, the European Chemicals Agency’s Forum conducted a large-scale EU/EEA enforcement pilot on Poison Centre Notifications (PCNs) and their consistency with label and SDS. Companies need to plan their actions as the 2026 outcomes have been released. (Source: ECHA – Pilot project on PCN report)

Scope of the Pilot Project:

• 18 EU/EEA countries participated (Belgium, Cyprus, Denmark, Finland, Germany, Greece, Hungary, Ireland, Italy, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Portugal, Romania, Slovenia, Sweden)
• 1,597 mixtures inspected
• 71% of inspected products came from SMEs

Key Findings:

• Overall compliance rate: ~58–59%
• 19% non-compliance where PCN submission was required
• 12% missing mandatory UFI (15% missing on labels)

This represents one of the most coordinated PCN-focused enforcement exercises to date.

This pilot project demonstrates how European Chemicals Agency along with the member states translates regulatory monitoring into concrete enforcement action. The identification of 656 non-compliant cases triggered corrective measures such as written advice, verbal advice, administrative orders including financial penalties and criminal referrals in more serious instances.  

Some of the severe Enforcement Measures imposed include:

Nearly 1 in 10 non-compliant cases led to financial penalties or criminal-level escalation.

Additionally, 222 cases remained under follow-up at the time of reporting, indicating that further measures may still be imposed.

What This Means for Companies

Authorities are actively reviewing PCN and UFI compliance and are willing to take appropriate enforcement action in cases of significant non-compliance.

PCN obligations should not be treated as a purely administrative submission. They form part of broader regulatory risk management and product stewardship strategy.

Targeted compliance audits covering PCN submissions, UFI placement, and alignment between PCN, labels, and SDS supported by experienced regulatory consultancies can help identify gaps early, reduce enforcement exposure, and strengthen compliance confidence across EU/EEA markets.

Why PCN is Required and for Which Mixtures

Poison Centre Notification (PCN) is required under Article 45 and Annex VIII of the CLP Regulation to ensure poison centres have accurate composition data for emergency health response. It applies to hazardous mixtures placed on the EU/EEA market that are classified for health hazards and/or  physical hazards. The obligation ensures that medical professionals can provide appropriate treatment in case of accidental or intentional exposure, making PCN a critical public health and regulatory compliance requirement rather than a purely administrative exercise.

If you require support with PCN compliance assessments, gap analysis, or enforcement risk mitigation, please contact us at sales@reachlaw.fi