Are Your Shortfills Complying With All the Required Legislation?

The Legislatory Environment Beyond TPD

Quality Control & Safety Assessment of Shortfill Products

Testing Eliquids for TPD Submission

Eos Scientific - Who We AreEos Scientific is uniquely positioned as a

UK-based scientific service provider.We

help eliquid manufacturers with eliquid

analysis and preparatory services for

compliance within the industry.

We also provide a wide range of

scientific services including:

• Chemical Testing

• Toxicology Data Research

• Regulatory Guidance

• Formulation of Vaping and CBD

Products

• SDS Writing and CLP Advice

Nick Ridgment

0800 009 6771

nick.ridgement@eosscientific.co.uk

www.eosscientific.co.uk

Shortfills Are Dominating Eliquid Markets...

The Importance of Testing and Quality Control of an ‘Unregulated’ Product

Shortfills are now the leading vape product for

many businesses.

They aren’t regulated under Tobacco Products

Directive. And while consumers might be una-

ware of the of the ingredients and without proper

labelling a consumer cannot make an informed

choice…

…more seriously the product could contain harm-

ful elements. And that could be a serious and

costly problem for any eliquid business.

The Tobacco Products Directive Strengthened the Rules on How Eliquids are Manufactured, Produced and Presented

The governing agency in the UK, the MHRA, said

that certain products are outside of the scope of

the TPD and do not have to meet its requirements.

This includes 0% nicotine eliquids – and this was

the very reason for the invention of the shortfill.

They could be bigger, by-passing the TPD regu-

lations of the standard nicotine-containing 10ml

bottles.

But any products being placed on the market are

still regulated under the General Product Safety

Regulations 2005 (GPSR). Including eliquids.

GPSR requires that only safe products are sold

on the market. It also imposes certain controls

to ensure the safety of goods sold to consumers.

Shortfills may not be regulated under the TPD but

businesses making shortfills still have a legal re-

sponsibility under the GPSR.

Under the GPSR the producer, or legally defined

representative of the producer, commits a crim-

inal offence if an unsafe product is placed on the market.

And with the TPD rules now embraced by the in-

dustry, and testing so easily available a defence

of ‘Due Diligence’ on an untested product is highly

risky.

Testing with Eos Scientific not only makes sure

that you supply safe and quality products but

gives you an edge in this competitive market.

Services at Eos ScientificOur modern labs analyse eliquids, giving you a very clear and easy to understand report.

Eos Scientific experts can help interpreting the test results too.

Eos Scientific analyse eliquid, test-

ing for safety and consistency in

compliance with the requirements

of Article 20 of the EU’s Tobacco

Products Directive (TPD) and the

equivalent legislation in the UK, the

Tobacco and Related Products Reg-

ulations (TRPR).

To be compliant, nicotine-containing

liquid in ecigarettes and refill con-

tainers must not contain additives

(these are listed in article 7(6) of the

regulations) and, except for nicotine,

must only include ingredients that

do not pose a risk to human health

in heated or unheated form.

We’ll also test to see if any reaction

or thermal degradation has pro-

duced compounds that pose sig-

nificant risk to consumers, or if any

contamination has occurred during

the manufacturing, bottling and

storage conditions.

We also fully understand the sub-

mission process, helping you achieve

success in getting a product to mar-

ket. For example:

• The submission must include a

list of all ingredients in the noti-

fiable products.

• The information should include

identifying details, the quantity

and function of ingredients and

further information about its

classifications and various as-

pects of its toxicity.

• Details of all available toxicolog-

ical studies of the ingredients in

unheated and heated form and

emissions should also be submit-

ted.

Our scientists help you reformulate

your product too, should that be

necessary.

More guidance on the flavourings

and the ingredients in eliquids can

be found on the MHRA website at

https://www.gov.uk/guidance/e-cig-

arettes-regulations-for-consum-

er-products.

TPD Testing

CBD Product Testing

PMTA Testing

Thanks to its reported medicinal

properties, the manufacture and

retail of products containing canna-

bidiol (CBD) is a fast-growing market.

But to be compliant these products

must have the Tetrahydrocannabi-

nol element removed to legally-ac-

ceptable levels. THC is the psycho-

active element in cannabis and is a

controlled substance under UK law.

Ensuring your CBD products contain

no more than the legally allowed

amounts of THC is crucial.

Eos Scientific offers a full CBD test-

ing service and a speedy turnaround

time. For example CBD content/po-

tency, heavy metal, terpenes, resid-

ual solvent and pesticide analysis

and following the tests we provide a

detailed certificate of analysis.

In the US, all manufacturers of ENDS

products, both liquids and devices,

must complete Premarket Tobacco

Product Applications for Electron-

ic Nicotine Delivery Systems (PMTA)

submissions.

Testing is laid down by the FDA. It’s

rigorous and often confusing...

Our scientific consultancy ensures

you are supported during every step

of the project, from initial quality

testing through storage testing and

beyond. We offer ingredient, toxi-cology, stability and emissions test-

ing and on-site storage and repeat

sample testing if required.

All documentation is delivered in an

FDA approved format, making your

submission even easier. Our labs

tests eliquids efficiently as well, to help quicker analysis, submission

and FDA compliance.

In the Lab:

GC-MS - Gas Chromatography Mass Spectrometry

TD-GC-MS - Thermal Desorption Gas Chromatography Mass Spectrometry

HPLC - High Performance Liquid Chromatography

ICP-MS - Inductively Coupled Plasma Mass Spectrometry

LC-MS - Liquid Chromatography Mass Spectrometry

Safety Data Sheets

Shortfill Testing

At Eos Scientific, shortfill products are tested in the liquid phase, and if

requested in the vapour phase, to the same requirements as the TPD.

We’ll provide a safety assessment of the formulation to highlight non-

TPD compliant ingredients. This helps towards ensuring any non-TPD

compliant ingredients are not present.

An SDS is a technical document

listing the identity of a substance

or mixture, the Classification, La-

belling and Packaging legislation

(CLP) hazards of the product, and

any obligatory supplementary

statements on the label.

This includes the physical and

chemical properties of the prod-

uct the physical, health and envi-

ronmental hazards of the product

and advice on disposal, and what

to do in an emergency.

A person or company who places

a product on the market is respon-

sible for producing the SDS (and

also the product’s classification

and labelling).

Eos Scientific SDS Services

1. Analysis of eliquids (in the ab-

sence of a breakdown list from

your flavour supplier).

a. Chemical content screen-

ing of e-liquids using GC-

MS for identifying the

presence of flavouring

compounds.

2. Classification of eliquids ac-

cording to CLP Regulation.

3. SDS authoring against CLP

Regulation requirements.

Eliquid containing nicotine of 20

mg/ml or less is classified as haz-

ardous under CLP legislation and

it is sold to the general public with

a safety leaflet as per the TPD

regulation. SDS need not be sup-

plied unless requested by a down-

stream user or distributor.

Nicotine-free eliquid is generally

not classified as hazardous, SDS

is supplied upon request as it con-

tains propylene glycol and glycer-

in, which hold Workplace Exposure

Limits (WELs) in the UK. However, e

liquid usually contains flavouring

components and the hazardous

nature of flavouring components

should also be considered when

preparing SDS, as this may also

trigger a requirement for appro-

priate CLP classification and la-

belling.

The Tobacco Products Directive 2014

In Feb 2014, the EU agreed a revised TPD which strengthened the legislation on

how tobacco products are manufactured, produced and presented in the EU. It also included regulations regarding electronic cigarettes, herbal products for smoking

and smokeless tobacco products.

-

Under Article 20, ecigarettes which contain less than or is equal to 20 mg/

ml nicotine are regulated by the TPD as consumer products.

-

Disposable ecigarettes that do not contain nicotine and 0% nicotine eliquids are out of scope of the TPD and do not have to meet its requirements. These products will continue to be regulated

under the General Product Safety Regulations 2005 (GPSR).

General Product Safety Regulations

2015

GPSR requires that only safe products are sold on the market

and imposes certain controls. These controls are set out to ensure that all products

intended for or likely to be used by consumers under normal or reasonably foreseeable

conditions are safe.

-

Under the GPSR the producer, or legally defined representative of the producer, commits a criminal

offence if an unsafe product is placed on the market.

-

The current maximum penalty is a fine of up to £20,000 and imprisonment for up to three

months.

-

The company and/or the individual directors are liable.

-

Due Diligence is the only defence to putting an unsafe product on the market. Due Diligence only

applies only where a defendant can show that all reasonable

steps and diligence was taken to prevent committing an offence.

Classification, Labelling, Packaging Regulations

The EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of substances and mixtures (CLP) came into force on 20th January 2009. From 1 June

2017, mixtures placed on the market must be labelled according to CLP.

Legislation: At a Glance

Your TPD Submission and Quality Control Safety Assessment with Eos Scientific

We have a seamless process from the receipt of your samples to delivering your reports on time.

Having your products tested not only makes sure that you supply safe and quality products but

gives you an edge in this competitive market.

We give you a very clear and easy to understand report and our experts are easily available if

you need assistance in interpreting the test results.

Eliquid AnalysisThis series of tests screens out the com-

ponents of your eliquid, including nicotine

percentage, PG/VG percentage, and uncov-

ers any undesirable compounds such as

diacetyl, acetylpropinoyl, acetoin, or diethyl-

ene glycol. It also detects any Tobacco-Spe-

cific Nicotine Nitrosamines (TSNAs)

Vapour Emission Testing

This uncovers any undesirable compounds in

your eliquid vapour, such as:

Aldehydes - including formaldehyde, acetal-

dehyde and acrolein, even in low parts per

million quantities.

Heavy Metals - to parts per billion quantities.

Our tests also detect any Tobacco-Specific

Nicotine Nitrosamines (TSNAs).

Nicotine Dose Consistency Test

This procedure determines if the eliquid nico-

tine dose is consistent.

Regulatory and Toxicology Advice

• As a follow-on from each analytical ser-

vice, we prepare reports, including toxi-

cology monographs, for your eliquid. The

final reports are presented in a manner

that is ready to submit to regulatory bod-

ies for approval. If your eliquid is found

not in compliance we can help design a

reformulation that’s more likely to pass.

• Optional submission to regulatory bodies:

we can prepare your submission to the

Medicines and Healthcare products Reg-

ulatory Agency.

• We also offer recommendations for TPD-compliant packaging.

Testing Through Eos Scientific

It would be reasonable for a consumer (and potentially the courts) to expect the same

standards when it comes to nicotine-containing and non-nicotine containing eliquids, such as

shortfills. Using Eos Scientific for testing and analysis is easy and helps protect your business.

www.eosscientific.co.uk

www.eosscientific.co.uk