EU Poison Centre Notification In Brief
Article 45 of CLP requires importers and downstream users to notify hazardous mixtures to the appointed bodies (i.e., poison centers) using the harmonized format (Annex VIII) before placing the mixtures on the market in the EU-27.
Adoption of New Annex VIII (Harmonized format) took place in March 2017, before which different Member States have different formats, fees, portals and requirements.
Deadline & ECHA Inspection 2025:
All Deadlines specific to each end user category including professional, consumer and industrial have been passed. With provided transition time, authorities have given to companies to perform timely notifications, it is now time where enforcement authorities have decided to perform inspection on the notifications performed. Inspection will begin from January 2025 & will continue for six (6) months. Although the full key scope of the inspection is yet to be defined in coming months however below are some key agenda
- Analyze PCN notifications performed qualitatively & quantitatively.
- Verify Labels of mixtures and – where needed – Safety Data Sheets (SDS).
- UFI related compliance and SDS update.
Deciding tree for PCN
Unsure if your mixtures fall under PCN requirements? Use the decision tree below as a guide to determine your obligations.
Confidentiality provisions in PCN
Limited submission: This term applies specifically to industrial-use mixtures, allowing companies to withhold certain information related to composition or formula—particularly the composition details found in Section 3 of the Safety Data Sheet (SDS). However, full composition disclosure becomes mandatory if the mixture is intended for consumer or professional use.
Role of Non-EU manufacturers/formulators and Commercial Representation
A non-European Union (EU) entity is not obligated to perform the Poison Centre Notification (PCN) under the Classification, Labelling and Packaging (CLP) regulation. However, they may provide the necessary information to an EU-based DU/importer to carry out the notification process.
If the non-EU entity wishes to keep the information confidential, they can assign an EU-based entity to perform a voluntary submission by generating a Unique Formula Identifier (UFI) by appointing a commercial representative in EU. The The EU-based entity can then make the mandatory submission, referencing this UFI in relation to the compositional information.
Take a look at the following graphic for further clarity:
Tips to consider when preparing your PCN notifications
Please keep the following points in mind while handling hazardous mixtures:
- Determine the correct category for the intended use of the mixture.
- Accurately identify your role in the process.
- Ensure the accuracy of the data submitted. If limited submission is required, ensure that the SDS is compliant with CLP.
- Manage the UFI (Unique Formula Identifier) efficiently.
- Comply with the deadline specified for the submission.
- Consider notification updates to adopt changes.
REACHLaw Services
- Regulatory consultation on PCN (role in supply chain, duty holder, complex scenario evaluation)
- Data checklist preparation & collection from the supply chain
- PCN Dossier preparation, submission (grouping) & dossier maintenance
- Commercial Representative Service to Non-EU Manufacturers
- Generate Unique Formula Identifier (UFI) & Management
- EU CLP classification for hazardous mixtures
- EU Safety Data Sheet (SDS) authoring
- Local emergency contact support for limited submission