For those who are unaware, an important deadline has recently passed, and you may be affected. As of the 1st of January 2025, a Poison Centre Notification (PCN) in accordance with Annex VIII (CLP Regulation (EC) No 1272/2008) is required to be submitted for chemical mixtures that are physically hazardous to human health. If your company has notified hazardous chemical mixtures directly to the National Poisons Information Centre of Ireland (NPIC) before this and you intend to keep placing the same mixtures on the market after the 1st of January 2025, you must submit a new poison centre notification (PCN) via the ECHA PCN portal, and include the unique formula identifier (UFI) on the label.
As of the 1st of January 2025, ‘old’ submissions sent directly to the NPIC are considered ‘archived’ and not compliant with regard to Annex VIII. If your product remains on the market prior to the 1st of January 2025 and is unchanged, you must make a new submission in the harmonised format via the PCN portal, as no migration of data from the NPIC database has occurred. If your product was discontinued before the end of 2024, you do not need to make a new submission.
Please note that the PCNs submitted through ECHAs portal can take some time to prepare, validate, and submit. You must compile all relevant information on the mixture and fill out the appropriate sections in the IUCLID database, before downloading the product dossier and submitting through ECHAs submission portal.
Please also note that the NPIC charges an annual retainer for use of its telephone number on the SDS of chemical products placed on the market in Ireland. The annual retainer is €650 per company (or €200 if notifying less than 10 products). Further information on this procedure can be found at https://poisons.ie/industry-manufacturers/safety-data-sheets/. To be able to use this number on the SDS you must also provide the UFI codes for any notified products, thus the need to submit a PCN.
Finally, inspectors from ECHA’s Enforcement Forum will be checking that your PCNs are submitted to national authorities. They will also verify labels and where needed, safety data sheets.
If you need support in the preparation and submission of Poison Centre Notifications for Ireland or the rest of the EU, please do not hesitate to contact the regulatory team at info@kerona.ie