Poison Centre Notifications

Poison Centre Notification in European Union

Notifying hazardous mixtures in EU member states and ECHA

Ekotox Centers are providing consultancy services and customers support in the area of EU chemicals legislation – EU REACH, CLP and more, Only Representative, REACH Authorisation, Safety Data Sheets, Legal Compliance Services, PCN and UFI services and more.

– just call us +421 2 45943712, send an e-mail on ekotox(at)ekotox.eu or skype ekotox.bratislava

PCN

Since 1 January 2021, importers and downstream users are obligated to notify their mixtures in a harmonised format and unique formula identifiers (UFIs) must be included on mixture labels. This is an important change for companies placing hazardous mixtures on the EU market.

Duty holders under Article 45 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. It is also important to consider that fulfilment of the notification obligation is a pre-condition for placing the mixture on the market – this may be important in cases where placing on the market is not performed by the importer or downstream user.

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

Annex VIII

HARMONISED INFORMATION RELATING TO EMERGENCY HEALTH RESPONSE AND PREVENTATIVE MEASURES

Importers and downstream users placing on the market mixtures for consumer use and professionals, shall comply 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.

Before placing mixtures on the market, submitters shall provide information relating to mixtures classified as hazardous on the basis of their health or physical effects to the bodies appointed under Article 45(1) (“appointed bodies”), in the Member State or Member States where the mixture is placed on the market. The submission shall contain the information laid down in Part B. It shall be submitted by electronic means in an XML format provided by the Agency and made available free of charge.

The Poison Centre Notification (PCN) format aims to structure the information on hazardous mixtures classified for health or physical hazards available to poison centres in cases of poisoning incidents in the EU.

Since 1 January 2021, importers and downstream users are obligated to notify their mixtures in a harmonised format and unique formula identifiers (UFIs) must be included on mixture labels. This is an important change for companies placing hazardous mixtures on the market.

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

advisory

Ekotox Ceneters – support for placing products on the EU market – just contact us by e-mail, social media, or call

Webinars and individual online training:

EKOTOXTRAINING.COM


Safety Data Sheet