Are Poison Centre Notifications to Become Mandatory in the UK?
The poison centre for Great Britain and Northern Ireland — the National Poisons Information Service (NPIS), announced in February, that despite previous contradictory advice from the government, Annex VIII of EU/GB CLP 1272/2008 ACTUALLY APPLIED IN THE WHOLE OF THE UK FROM 1st January 2021.
During the EU Withdrawal discussions, we were advised that Great Britain would not be implementing this as the entry into force date was after the UK left the EU. We were informed that the existing poison centre notification process in Great Britain would remain voluntary, and that you would only need to send a copy of your safety data sheets to the NPIS.
However, the NPIS has already started to reject voluntary submission of safety data sheets and have advised that all notifications must now be in accordance with Annex VIII.
Confusion
It was discovered that Annex VIII was accidentally copied across, and inadvertently implemented, into UK law by the Department of Health and Social Care (who run NPIS).
The confusion seems to arise from the fact that Annex VIII was out of scope based on the original Brexit timeline (as communicated to industry). However, the change of the Brexit timeline, and the wording of the Withdrawal Act (ie ‘applies from’ date, not submission date) means that it came back into force, and the Department of Health did not notice.
It appears that someone at the Department for Health has now realised, and have informed NPIS that they need to act. NPIS has withdrawn their guidance, started rejecting SDSs, and are asking for harmonised files to comply with the actual law.
So, at the moment it looks like Annex VIII legislation appears to be valid, unless officially repealed.
How would this impact organisations placing mixtures on the market in Great Britain?
If Annex VIII were to be implemented, it would mean that for importers and downstream users, submitting a poison centre notification would now be mandatory.
Which would mean:
- The addition of the UFI on the label, and SDS, as part of the Poison Centre Notification.
- Hazardous mixtures with physical and health GHS hazards require Poison Centre Notification.
- Consumer, professional and industrial mixtures are all required to be notified.
The NPIS is, at the moment, asking for any product notifications made since Jan 1st 2021 to be resubmitted in the I6Z format.
If you have already submitted safety information for Northern Ireland for an identical product sold in GB, then those will already be on the system, can be considered as notified, and no further action is required.
If you operate only in the UK and haven’t notified the product – it will need to be notified and a IUCLID file must be created.
You will need to re-submit any poison centre notifications made since 1 January 2021 in the Annex VIII harmonised format to be compliant.
What Next?
It is still unclear if Annex VIII will be removed from UK law, but as it stands, the NPIS are viewing this through the lens of compliance, and as such, expect companies to act in compliance with this regulation.
The HSE has confirmed that they will look at any enforcement decisions on a case-by-case basis. They will consider the efforts made by duty holders to achieve compliance as well as the level of risk when making enforcement decisions.
The Government is now launching a public consultation on whether to revoke Annex VIII from UK law. This 12-week consultation period will allow all interested parties to provide evidence in support of, or against, the revocation and will be published in due course.
The situation is still very uncertain, and the NPIS website is currently on hold regarding updated guidance, but industry experts are advising that it is looking more and more likely that the Annex will be retained.
To ensure you are meeting your obligations in the UK please keep informed by the NPIS website: www.npis.org
How can Hibiscus Help?
For further information regarding chemical label and safety data sheet compliance contact us on 0113 242 4272.
Email: enquiries@hibiscus-plc.com or visit Prometheus at Hibiscus
If you print your own labels, we can also provide the appropriate substrates and printers with Managed Print Solutions to enable you to keep abreast of the latest regulations and produce labels that are fully BS5609-compliant.