CLP Annex VIII to be adopted in Great Britain: What you need to know and how to comply
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With the UK Department for Health and Social Care adopting the EU Annex VIII to the Classification, Labelling and Packaging (CLP) of Substances and Mixtures Regulation (EC No 1272/2008) into GB CLP, organizations looking to place mixtures on the GB market are required to submit a poison centre notification.
Although ANNEX VIII was thought to be out of scope, the change of the Brexit timeline and the wording of the Withdrawal Act (ie ‘applies from’ date, not submission date) means it came back into force, and the HSE and DEFRA did not notice. Here is some more insight:
All of CLP (which includes Annex VIII) was brought into effect on January 1, 2020
If the original Brexit timeline applied, then Annex VIII would not have applied
Brexit's original date changed from before January 1, 2020, to January 31, 2020
Taking January 31, 2020, as “Brexit day” (which is what happens on the legislation.gov.uk website), Annex VIII did become applicable to Great Britain
As a result, at the moment it looks like Annex VIII legislation appears to now be valid in the GB market.
How does this impact organisations placing mixtures on the market in GB?
For importers and downstream users placing certain hazardous mixtures - for consumer or professional use, on the market in Great Britain, it means:
It's mandatory to submit a poison centre notification - if you chose not to notify previously, you now need to do so to remain compliant
You need to re-submit poison centre notifications made since January 1, 2021, in the Annex VIII harmonised format to be compliant
If you have already submitted safety information for Northern Ireland for an identical product sold in GB, then those will be on the system and are considered as notified
If you notified to another EU country in the Annex VIII format, the files must be amended and submitted to the NPIS
If you operate only in the UK and haven’t notified the product – it will need to be notified and an IUCLID file must be created
If you have only submitted a safety data sheet for industrial use, then you do not need to do anything further at this time, and you can continue to submit SDS up until the industry deadline of 31/12/2024
What now?
The picture is still very unclear, and the NPIS website is currently on hold regarding updated guidance, but to ensure you are meeting your obligations in the UK, please keep informed by their website: www.npis.org. As you wait for an official announcement, we recommend getting prepared by identifying products that meet the relevant definitions and are required to be notified as part of Annex VIII of CLP.
How can Yordas help?
We provide support at every step of the notification process and can help you:
Identify products that meet the relevant definitions and are required to be notified as part of Annex VIII of CLP
Poison Centre dossier preparation
Re-submit your poison centre notifications under GB CLP in the Annex VIII harmonised format
Manage all formal communication with regulating entities with respect of Poison Centre Notifications
Monitoring guidance on CLP Annex VIII and advising on matters relating to Poison Centre Notification activities
Maintaining all records and data on products covered by the service agreement and required by the regulators
You can get in touch with our Poison Centre experts today by sending us a message here.