Poison Centre Notifications

Poison Centre Notification in European Union

Notifying hazardous mixtures in EU member states and ECHA

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EU Market Regulations: Notification Obligations for Hazardous Mixtures and Duty Holders

Since 1 January 2021, importers and downstream users are obligated to notify their mixtures in a harmonised format . This is an important change for companies placing hazardous mixtures on the EU market.

Duty holders under Article 45. For example are defined as importers and downstream users placing hazardous mixtures on the market. In all cases, the obligation lies with the EU legal entity, which means that a non-EU supplier of the mixture cannot replace the EU-based duty holder. Additionally, one must take into account that the fulfillment of the notification obligation serves as a prerequisite for the placement of the mixture on the market.

Commission Delegated Regulation (EU) 2020/1677 of 31 August 2020 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures in order to improve the workability of information requirements related to emergency health response

PCN

Annex VIII

HARMONISED INFORMATION RELATING TO EMERGENCY HEALTH RESPONSE AND PREVENTATIVE MEASURES

Importers and downstream users introducing mixtures to the market for both consumer and professional applications must ensure compliance starting from 1 January 2021.

Importers and downstream users having submitted information relating to hazardous mixtures to a body appointed in accordance with Article 45(1) before the dates of applicability and which are not in accordance with this Annex, shall for those mixtures not be required to comply with this Annex until 1 January 2025.

The Poison Centre Notification (PCN) format, specifically tailored for organizing information, pertains to hazardous mixtures categorized for health or physical hazards. This format ensures that poison centers within the EU have access to crucial details in the event of poisoning incidents.

Starting from January 1, 2021, there has been an obligation for importers and downstream users to notify their mixtures, all presented in a harmonised format. Furthermore, it requires seamless integration of unique formula identifiers (UFIs) onto the labels of these mixtures. This is an important change for companies placing hazardous mixtures on the market.

New EU PCN format

Annual updates of the format occur in October in line with the IUCLID release schedule.  There is also a data model that shows all relevant fields and their interconnections.
Version 4.0, published on 25 October 2021

Most EU countries are now accepting notifications through the ECHA Submission portal.


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Safety Data Sheet