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Damian Bové, Adact Medical’s Chief Regulatory Officer, discusses
changes across Europe to poison centres notification processes,
short-fill regulation and preparing your products for sale in the UAE.
New European legislation has come into force recently, after a delay
due to IT issues. But it is here now and it will affect e-liquids, TPD
and short-fills.
It’s a requirement to centrally register all products with a hazard
classification with the Central European Poisons Centre. We have
until December to be compliant and whilst at the moment it does not
affect UK businesses, the UK has yet to bring the required legislation
into force. It is in place across Europe and Germany in particular are
requiring it. If in the UK Brexit does not happen, this will affect all UK
businesses as well.
The measures require you to register your products with the central
European portal where you will be issued with a Unique Formulation
Identification code (one for each product). This code is then put
on your packaging typically via the barcode. The idea being that
if there is a poison incidence, a poison centre can enter the code
into their system and immediately see a breakdown of the product’s
formulation. This is going to be disruptive in many ways.
Firstly, there is the administration and the logistics of getting things
registered. Like the TPD, it requires you to have access to your
full formulation and CAS numbers, which can be challenging. This
regulation does not apply to foods, so it may come as a surprise
when you ask your flavour house about it. The full formulation is
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required however ranged data can be given. It’s not enough to just
put the information from the MSDS sheet into it.
The key issue that has to be tackled: It’s not clear how confidential
the data will remain in the system, so I expect quite a lot of activity
in this area over the next few months and into next year. There is
discussion of extending the deadline for compliance and this may
be needed. If you have notified your products to a national poisons
centre you’re exempt from compliance until 2022.
Short-fill regulation comes to Europe
There is a misconception that short-fill vaping products are not
regulated when they are in fact covered by the GPSR 2005, which
to cut a long story short means TPD without the notification applies
to short-fill products.
Holland, Austria and Greece, have gone all official with short-
fill regulation. These are now regulated as TPD products, which
means you have to do a full TPD notification of the products and file
them through the EU portal. You can put the larger bottles through,
you’re not limited to 50ml but they want them notifying and where
appropriate notification fees will be payable.
This trend looks set to spread to other European states. At the
moment there is no sign that the UK will ask the same. However, we
should watch this space.