During the discussions for the UK’s withdraw from the EU, the UK authorities indicated that the UK Poison Centre Notifications would remain Voluntary and only require submission of an SDS to the National Poisons Information Service (NPIS). This was continuously communicated to business throughout and even after the end of the transition period by both DEFRA and the HSE that Annex VIII was not being brought into UK law on Brexit. However, it has recently come to light that the Annex VIII of the EU CPL 1272/2008 is in fact part of UK Law and has been so since the 1st of January 2021.
How this Happened?
It was discovered that Annex VIII was accidentally copied across into UK law by the Department of Health and Social Care (who run NPIS, the National Poisons Information Service). So, it's not DEFRA or the HSE's fault, nor is it NPIS's responsibility, as they simply operate their service. This means that the UK have inadvertently implemented Annex VIII into UK law.
What is Next?
Since the accidental inclusion of Annex VIII into UK Law was discovered, the NPIS have begun enforcing this aspect of the regulation, meaning that many companies have been out of compliance with this regulation since the 1st of January 2021. Additionally, the NPIS has already begun rejecting voluntary submission of SDS and have advised that all notifications must now be in accordance with Annex VIII. It is still unclear if there will be moves to remove Annex VIII from UK law but as it stands the NPIS are viewing this through the lens of compliance and as such many companies will need to become compliant with this regulation.
How to Become Compliant?
All of the Annex VIII requirements are in UK law this includes,
- Mandatory Poison Centre Notification.
- Use of the UFI on the label and as part of the PCN.
- Hazardous mixtures with physical and health GHS hazards require PCN.
- Consumer, professional and industrial mixtures are all required to be notified
Currently it is not clear if the deadlines in Annex VIII will be the same and as for EU-CLP Northern Ireland PCNs made by sending your IUCLID6 .i6z file to NPIS will count for the rest of the UK. The method of notification is the same as Northern Ireland, that is you send your IUCLID6 .i6z file via email (or multiples on a memory stick) to email@example.com
You don't need to act if you've notified all your hazardous mixtures for Northern Ireland by submitting an i6z file to NPIS. This will be deemed as being notified for the rest of the UK.
You do need to act if you've not notified to Northern Ireland and have hazardous consumer or professional mixtures. If you have hazardous industrial mixtures, according to the timelines in Annex VIII, you have until 2024 to do this.
CIRS can offer a full UK-PCN service in tandem with our Harmonised EU PCN service for both Non-UK and UK based companies. Our service includes,
- Dossier Preparation/Evaluation
- Dossier Submission
- SDS Preparation/Review and updates
- UFI Code Generation
If you have any questions or would like to enquire about any of the services we can offer your business, please feel free to contact us as we would be happy to help.
Senior Regulatory Consultant, CIRS Europe
Phone: +00 353 (1) 477 3706