From January 1, 2025, all mixtures already placed on the EU market that are classified for human health or physical hazards must be notified using the harmonised Poison Centre Notification (PCN) format prepared with the IUCLID software. Only 10 weeks remain to ensure compliance.
Poison Centre Notification: Transitional period ends December 31, 2024
October 22, 2024
The required information, designed to support medical advice in emergencies, is set out in Annex VIII of Regulation (EC) No 1272/2008 (CLP).
Mixtures for consumer, professional or industrial use, such as biocidal products or plant protection products, previously notified to national poison centres and not compliant with Annex VIII, must be re-notified in the harmonised format via the ECHA Submission portal. No migration from national databases (such as NPIC in Ireland) to the ECHA portal is expected.
Avoid non-compliance
The transitional period ends on December 31, 2024. After this date, any mixtures with human health or physical hazards placed on the market and not notified using the ECHA PCN portal will be non-compliant.
Additionally, by January 1, 2025, the UFI (Unique Formula Identifier) number must be added to the product label and Safety Data Sheet (SDS) for such mixtures.
If neither of these have been done, it’s important to act now. Only 10 weeks remain to complete the ECHA harmonised PCN, as well as update the label and SDS.
Sagentia Regulatory can help
Sagentia Regulatory’s, formerly TSG Consulting’s, regulatory team is experienced in submitting PCNs for various mixtures in accordance with the ECHA harmonised system. For support with PCNs, as well as preparing and updating EU-compliant SDSs and labels, please reach out to us at [email protected]. Our teams are here to help.
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