Compliance and Your Vape Business. How the Tobacco Products Directive Affects You

 

Choose the Right Eliquid Producer

The vaping world is having to adjust fast to article 20 of the Tobacco Product Directive (TPD), which tightens regulations on the selling of vaping products.

TPD actually entered into force in May 2014 and, following a transition period, the upshot is that all products sold from 20th May 2017 must be compliant. From that date they can no longer be sold legally in the UK, nor can they be sold to any other EU member country that allows for distance selling of vape products.

And if you’re found selling a non-compliant product you risk hefty fines, or more serious measures.

TPD sets out minimum standards for the safety and quality of all e-cigarettes and refill containers, or eliquids, and to provide consistent information to consumers so that they can make informed choices.

And TPD also aims to provide an environment that protects children from starting to vape.

As a vape retailer you’ll want reassurance that your supplier or producer is compliant. Has your supplier or producer submitted the eliquid ingredients correctly? Is the packaging and labelling compliant?  At Eliquid Solutions we sell eliquids, as well as test them, so we are also bound by the directive as a retailer.

If you run a vape business you’ll need to make sure that your manufacturer or producer has submitted their product details to the MHRA.

In the UK all vape product details must now be submitted to the Medicines and Health products Regulatory Authority (MHRA), which is implementing the TPD.  Submissions need to be made 6 months in advance of the product being sold in the market. And then listed on the MHRA website.

If your usual supplier can’t prove compliance with this, you’re at risk.  As a retailer your successful transition to TPD compliance begins by choosing a trusted producer from the start.

If You Run a Vape Business that Relabels Eliquid Will You Need to Submit Details to the MHRA?

Under the rules a ‘retailer’ sells e-cigarettes 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 notification of those products to the MHRA as long as the manufacturer or producer of the relabelled goods has already notified the MHRA of the product details.  For example all Eliquid Solutions’ products have been submitted to the MHRA and our customers that relabel these are fully compliant.

So, if you’re looking for new suppliers or materials make sure they are TPD compliant and can prove it. 

There are some other notable changes under the TPD too:

  • Refill bottles can only be a maximum 10ml and must be leak-free
  • Tanks will have a maximum 2ml capacity
  • Dripper bottles will be discontinued
  • A maximum nicotine content of 20mg/per ml (2.0%)

You can reassure your end consumer that the TPD rules won’t apply to them using older devices or liquids as personal use – no-one will be guilty vaping ‘illegally’ in the street…

Check Your Labels Are Compliant

Labels need to have the ingredients listed, and a batch number.  Packaging needs a nicotine warning message in the same way cigarettes currently do.

‘Non Permitted Text’ – Descriptions and Labels Under TPD

TPD has also changed the way you can promote vape products.

For example ‘Tastes like mum’s custard …’ is not allowed under the new rules.

TPD labelling regulations state that you can’t say it’s ‘the cheapest’, or that it offers health benefits, is less harmful, is energising…

The rules cross a fine line between the allowed mentioning of flavours, and implying something like a home-made taste, considered erroneous by the directive, as in the example above.

When it comes to the promotion of vaping, think tobacco advertising. The rules are now similar.  Stick to the facts.

Custom Made – What About New Flavours?

Under 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.

But also any product which has been ‘substantially modified’ will count as a new product and must also follow the new process. This 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.

If your supplier cannot meet all these provisions you will be unable to sell those products on to consumers.  Choosing the right producer is so important.

Eliquid Solutions

Eliquid Solutions manufactures and tests eliquid for vape businesses across the UK.

Our production and testing facility is UK-based and ISO 9001, 14001 and OHSAS 18001 certified, with the capability to test and analyse all eliquids.

We also have first-hand experience of the Tobacco Products Directive submission process through our consumer facing brand Vapemate.  We use the same expertise to assist other eliquid manufacturers with TPD compliance testing, reporting and regulatory advice.

Eliquid Solutions uses BP/Food Grade Vegetable Glycerine and Propylene Glycol and Pharma Grade nicotine.

Measuring Ingredients and Vapour in Eliquids

Utilising a combination of Thermal Desorption, Gas Chromatography, High Performance Liquid Chromatography, Inductively Coupled Plasma Mass Spectrometry we separate, identify and quantify complex combinations of eliquids and eliquid emissions.

This allows us to accurately detect the ingredients in our eliquids and their vapour. We can give accurate quantities of detected target compounds, and offer corresponding Chemical Abstracts Service (CAS) numbers, if required.

 

As part of TPD compliance we detect emission compounds in three areas:

– aldehydes (measured to the lower levels of nanograms/puff)

– heavy metals (measured to the lower levels of nanograms/puff)

– the rest of the undesirable compounds as per the MHRA emission guidance (including 2, 3 pentanedione, benzene and toluene – measured to very low concentrations)

Nicotine Dose Consistency Testing and Stability

Eliquid Solutions test nicotine stability for samples stored in normal conditions at 1 month, 3 months and 6 months (this will increase to 1 year and 2 years).  All our e-liquid Solutions nicotine content meets the consistency test, as per the MHRA guidelines.

We can also test the nicotine quantity of your products to ensure you are not exceeding the legal limits.

 

Eliquid Solutions – A Complete Eliquid Business Service

  • TPD complaint including packaging – all in one place
  • ISO 9001, 14001 certified production facility
  • OHSAS 18001 certified production facility
  • 250 compliant flavour concentrates
  • 0-100% VG concentration available
  • Range of 0, 3, 6, 12, 18 MG Nicotine strengths
  • Product personalisation: branding, packaging, labelling

 

You can get recommendations for packaging to make your product TPD-compliant, and give you the option of preparing and submitting your final proposal on your behalf.

 

Contact Eliquid Solutions

If you want to discuss TPD for your business or just want some advice we’ll happily talk it through with you.  Just contact us using the details below.

www.elquidsolutions.co.uk
phone: 0844 351 1028
email: business@eliquidsolutions.co.uk