F E AT U R E
Note that all ingredients in the product
should be listed on the label where
they are used in quantities of 0.1%
or more of the final formulation of
the e-liquid.
0.1% in my opinion is a bit of a joke
due to levels of statistical significance,
but then the commission and
subsequent twisted interpretations
have made best attempts at making
a mock of the lengths companies need
to go through to obtain regulatory
status as this potentially reduces big
tobacco competition in this sector.
Where a flavour ingredient contains
several component chemicals, the
MHRA considered it acceptable to
describe the ingredient on the label
by the name of the flavour, for
example ‘strawberry flavour’.
For confidentiality reasons companies
may choose to describe individual
ingredients used in quantities
below 0.1% of the final formulation
by category, for example ‘other
flavourings’.
This advice only applies to product
labels, and a full list of ingredients
in the flavouring must be included
in notifications through the EU-CEG.
Can I take my flavour house to
court? They are not releasing CAS
numbers to me and I am legally
obliged to provide profile details, as
you know. What is your best advice?
Also if this is a magazine question
can I remain anonymous?
Mr Anonymous, Somewhere overseas
Well Mr Anonymous, I suppose you
could get a legal team involved,
76 ISSUE 07 VAPOUROUND MAGAZINE
especially if the lack of information
stops your company from notification
and producing product after November
20th for the European market.
I would maybe broach the subject
with your flavour house and establish
if they own the IP on the formulation
you manufacture and sell.
Some flavour houses have opened up
and started to disclose to us the CAS
% levels of inclusion under NDA and
transferring via secure FTP upload
so do not despair, although slow,
things are starting to move and
company attitudes are starting to
change too.
I’ve heard that if you have a tobacco
flavour it now needs a new test
for TSNA’s, however when we
completed notification this test was
not included, do we have to amend
our notification?
Mr G Green, London
In a nut shell, yes, and this TSNA test
has only recently been included as an
MHRA requirement. I am almost fearful
of by how much these goal posts
can keep changing so close to the
deadline. I’m not the only one thinking
that these changes and requests are
not legal at this late stage based on
our clear deadline of November 20th.
The labs are full or filling up at a rate
nobody expected and if you were
unlucky enough to notify early then
these changes in requirement do need
to be addressed.
I am struggling to understand what
is required for notification regarding
Toxicological information, can you
summarise what is required for
liquids and why?
Mr J Shah, Manchester
Toxicology is the most important part of
the process in my opinion, it basically
dictates whether a product is safe for
human use and consumption, straight
forward when it comes to hardware
and extremely complex when we look
at liquid formulations.
You first need your formulation broken
down into its individual component
parts and to provide CAS numbers
for every ingredient as a start including
% levels of inclusion.
Once your emissions tests come back
from the lab the toxicological research
can be completed and signed off per
flavour profile.
If any red flags are identified, our Tox
team will help re-formulate in order
to provide an amendment to any
notification previously submitted.
Hope this helps!
Now having answered a few of your
questions, I am back with the nose on
the grindstone, the next two months will
fly past, I have very little time to myself
as it is and I think come Christmas I will
be feet up looking at the next round of
challenges that face this industry.
Keep your questions coming in,
I answer all of them even if they’re
not included in print so do not be shy.
I look forward to writing my next
Vaporound feature.
[email protected]