Nicotine Analysis

With the TPD in full force now alongside the PMTA we deliver the following nicotine analysis services helping to ensure your product is compliant.

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How Our Nicotine Analysis Services Can Help You

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Eliquid TPD Analysis & Reporting (Four weeks)

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Regulatory Submission (Eliquid & Hardware) (Two weeks)

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Monograph/Toxicology Writing

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Eliquid PMTA Analysis & Reporting (Four weeks)

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SDS Writing

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MHRA Submission Preparation (Two weeks)

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CLP Guidance

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The Tobacco Products Directive (TPD) at a Glance

MHRA Submissions

All eliquids have to be submitted to the Medicines and Health Products Regulatory Agency (MHRA) for approval before going on sale.

Refil Bottles

Refill bottles can only be a maximum 10ml and must be leak-free

Nicotine

Refills can have a maximum nicotine content of 20mg/per ml (2.0%)

Tanks

Tanks must have a maximum 2ml capacity

Packaging

Packaging must also be compliant – following similar rules to tobacco packaging

Advertising

Advertising, marketing and promotion is restricted

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Further guidance on TPD regulation is available on the UK Government website.

Submissions to the MHRA

All eliquids and the resulting vapour have to be analysed and the results submitted to the MHRA for approval before they can be sold. The MHRA has published a list of undesirables and has advised submitting eliquids 6-months prior to sale, although it may take less time. Submissions are also listed on the MHRA website.

As part of TPD compliance we test both eliquids and the vapour produced during vaping to detect and quantify all substances of concern according to the MHRA guidelines.

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We Test Eliquids:

to screen for any substances that shouldn’t be in the liquid including tobacco specific nitrosamines (TSNAs) for tobacco related flavours
to determine ingredient composition and quantity

We also test the nicotine quantity of your products to ensure you are not exceeding the legal limits, as well as testing for the dose consistency.

Eos Scientific analyses emission compounds in three areas:

aldehydes (measured to the lower levels of nanograms/puff)
heavy metals (measured to the lower levels of naonogrms/puff)
the rest of the undesirable compounds as per the MHRA emission guidance (including 2, 3 pentanedione, diacetyl, benzene, toluene…, – measured to very low concentrations)

Nicotine Dose Consistency Testing and Stability

Eos Scientific also tests eliquid ingredient stability for samples stored in normal conditions at 1 month, 3 months, 6 months and 12 months. This will help to predict the shelf life of your product.

Producers, Manufacturers and Retailers

Producers and manufacturers are required to notify their eliquids to the MHRA (by submitting the required documentation and information through the TPD submission portal). Under the rules a ‘retailer’ sells ecigarettes and/or eliquids by retail to the general public. If you sell relabelled products you’re also defined as a ‘Producer’. Technically, a ‘Producer’ must notify the MHRA about their products.

But if you sell relabelled products, you won’t need to submit those as long as the manufacturer or producer of the relabelled goods has already notified the MHRA of the product details.

Custom Made Eliquid and New Flavours

Under the TPD any new products are subject to the submission process with the MHRA and of course are required to be submitted 6 months prior to going on the market.

Any product which has been ‘substantially modified’ need to be resubmitted the process includes:

any change to the qualitative or quantitative composition of the nicotine-containing liquid
any change to the volume of a refill container, tank or cartridge
any change to the composition or power output of a device which would be likely to affect emissions

For further information on the requirements for TPD submission is found at the following MHRA link.

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