NEWS
Why Your E-liquid Needs To Be
Tested, Approved and Awarded
A Technical Dossier
There are two main reasons why the
e-liquids sold to customers as vaping
products need to be tested:
because your customers have the right to
know that the product is not harmful and
because the law says it must be tested.
We dealt with the first part in the
accompanying article about e-liquid testing
laboratory EL Science which extensively
quoted the views of its Technical Director
Shaun Wedgwood.
In a nutshell, customers have the right
to be reassured that the vaping products
sold to them are not going to be unsafe
for them to use. That alone is a very good
reason why the vaping industry as a
whole should welcome, encourage and
actively promote the testing of e-liquids.
As far as the law is concerned, if anyone
wants to sell e-liquid within Europe then
they must comply with the Tobacco
Products Directive (TPD) which came into
force on May 20 this year.
The primary requirement of the TPD
as it applies to e-liquid testing is that
manufacturers and importers must submit
a ‘technical dossier’ to the relevant
authorities for each product sold.
In the UK the relevant authority is the
Medical Health Regulatory Authority
(MHRA) and a technical dossier for every
e-liquid flavour sold must be provided to
them by November at the latest.
The technical dossier must:
• Contain administrative information
such as addresses, descriptions and
declarations.
• Detail the full chemical composition.
• Provide a complete set of toxicological
data for each chemical component.
• Have an associated Toxicological Risk
Assessment (TRA) prepared using the
accumulated data for each end product.
EL Science has been working closely with
the MHRA and wants to be able to set
the ‘gold standard’ for e-liquid testing to
ensure that not only is the law complied
28 ISSUE 05 VAPOUROUND MAGAZINE
with but that customers can feel confident
that the products they will vape have been
thoroughly and rigorously tested by highly
competent experts.
When EL Science carries out a full
Toxicological Risk Assessment, the
process can be split into five main stages.
Stage One – Toxicological
Determination
EL Science works with specialist, fully
registered toxicological companies to
determine the toxicological profiles of
over 300 individual chemical components,
which form the base components of the
vast majority of flavour concentrates.
Each chemical is individually assessed for
potential adverse effects, and components
of concern will be further investigated to
achieve effective threshold limits.
Stage Two – Compositional
Determination
The chemical composition of an e-liquid
must be determined through a combination
of supplier information and analytical
determination and confirmation. The
EL Science laboratory contains the
very latest high specification GCMS,
Thermal Desorption, Atomic Absorption
equipment and a whole range of smaller
laboratory instrumentation which has been
specifically chosen and commissioned to
allow for chemical compositional analysis
of e-liquid and e-liquid vapour.
Stage Three – Thermal Degradation
Profiling
While no direct combustion occurs
during the usage of e-cigarettes, the
atomiser coil may elevate temperatures
to above 300 degrees celsius. At such
high temperat ures, certain chemicals can
degrade so it is important to investigate
these potential degradation pathways. This
investigation work is then confirmed by
GC/MS Thermal Desorption technology.
Stage Four – Toxicological Risk
Assessment
Where appropriate, utilising the data
generated in the previous stages, a
full TPD compliant Toxicological Risk
Assessment (TRA) is compiled for the
specific e-liquid flavour under examination
for inclusion in the Technical Dossier.
Stage Five – Compilation and
Submission
The EL Science team of organic chemists
ensure that each Technical Dossier is
correctly compiled and compliant with
submission requirements. Only when the
team is fully satisfied that the Technical
Dossier contains all the required data do
they submit the notification directly to the
MHRA.
It can be seen that the vaping industry
has come a long way since the early days
when people would just mix flavours
together in the hope of finding ones which
tasted good.
Now we have developed as an industry to
the point where we can use the very best
that science and chemical analysis can
provide to provide great flavours which
have also been shown to be free from
harmful compounds.
As EL Science’s Shaun Wedgwood
put it: “We can no longer develop new
flavours based solely on taste - flavour
development has now become a merging
of art and science.
“In our new post-TPD world, flavour
development is something which will take
months, not weeks, and putting a new
flavour onto the market is going to take
a significant investment and become a
significant business decision.”
* To find out more on being TPD compliant,
you can contact Shaun Wedgwood at
[email protected] or call 01733
352553.