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REGULATION (EU) NO. 2017/542

European harmonised notification to Poison Centres

What are toxicological data sheets?

Prior to this regulation’s publication, the procedure for notifying mixtures to poison centres was each state’s responsibility. In Spain, notifications were sent to the Spanish Institute of Toxicology and Forensic Science (INTCF) via “Toxicological data sheets”.

On 22 March 2017, the Regulation (EU) No. 2017/542 was published, which amended the Regulation (EC) No. 1272/2008 (CLP Regulation) by including a new annex: Annex VIII – Harmonised information relating to emergency health response and preventative measures.

Annex VIII was amended on 29 October 2019 by the COMMISSION DELEGATED REGULATION (EU) 2020/11 and later by the COMMISSION DELEGATED REGULATION (EU) 2020/1677 (currently in force).

From toxicological data sheets to sending PCN Format files to the ECHA

  • Notifications made in line with the current procedure – before Annex VIII comes into force – will be valid until January 2025 (except for necessary amendments).

  • According to the new regulation, any affected product must be notified in January 2025.

  • At present, any new communication or update of an existing notification must be made according to Annex VIII of CLP.

Importers and downstream users that have hazardous mixtures on the market are the duty holders according to CLP Regulation. This obligation always lies with the EU legal entity, which means that a non-EU supplier cannot replace the EU-based duty holder.