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Guest Post: Everything you need to know about TPD

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Hello folks,

This is an interesting article around Tobacco Product Directive (TPD) which was shared with me by one of the biggest eliquid manufacturer in UK. The company’s name is ChillOhm. I request everyone to go through this article as it has some really good revelations which we all have to understand and keep in mind whether we are doing DIY or buying juices locally. A bad or contaminated juice is as good as smoking a cigarette. Feel free to ask you vendor about the questions related to their lab or unit where juices are being made. You should be mindful of the juices that goes inside your body.

Tobacco Product Directive (UK & EU 2016)

This new law came into effect on 20th May, 2016, with huge implications for the e-cigarette industry. The driving force behind introduction of the Law was increasing use of e-cigarettes among the population and consecutively reduction is traditional forms of tobacco smoking.

Astronomical rise in use of E-Cigarettes in a very short span of time across Europe & UK have highlighted many issues of quality and safety which the new law aims to address. A detailed study was conducted to identify the potential ways in which the liquid used in E-Cigarettes could be harmful for human consumption and ways in which these can be minimised or eliminated completely altogether. Based on these results and after lengthy & copious discussion with the industry, the final TPD Act was formulated.

THE PRIMARY REQUIREMENTS OF THE TPD ARTICLE 20 ARE SUMMARISED BELOW:

  • Manufacturers and importers must submit a technical dossier to the relevant authorities (the MHRA in the UK) for each product.
  • A nicotine-containing liquid will have a maximum strength of 20 mg/mL.
  • Additives are highly restricted.
  • Refill bottles are limited to 10 mL, and pre-filled refill tanks and cartridges are limited to 2 mL.
  • Advertising is heavily restricted.
  • There are some restrictions on cross-border sales.
  • Retailers and manufacturers are required to share market data and trends with the competent authority.

Where sufficient robust data becomes available, member states may effectively ban individual products.

So how does the advent of legislation impact the e-liquid manufacturing industry:

Toxicology Testing:

To comply with the TPD-2016, all E-Liquids manufacturers in UK & EU after May, 2016 will have to submit a detailed Toxicology report to the authorities at least 6 months prior to product going out for sale. The Tobacco Products Directive (TPD) requires that the emissions resulting from the use of electronic cigarettes are quantified. Every batch of e-liquid manufactured will have to be tested for Carbonyls and Nicotine Emissions. The MHRA (the authority regulating TPD in the UK) have issued guidance requesting Acetaldehyde, Acrolein and Formaldehyde to be assessed, however at Dr Nain Laboratories (UK), our testing package for e-liquid also tests for Crotonaldehyde, Propionaldehyde and Butyraldehyde, as these are commonly found in the aerosol and there is potential for other EU member states to ask for these to be quantified.

Myth buster: The common notion of “The more, The Better” does not hold true in E-Liquids. You don’t need to be a scientist to work out that more chemicals that you will heat; it will ultimately result in more toxic residue (in case of e-liquid, vapours).

To protect against this harmful emission the TPD aims to address both “The Quality and The Quantity” of the flavours used in E-Liquid manufacturing process. The detailed testing of the product will ensure that the product is within safety limits. Invariably that will mean that manufactures will have to reformulate their Liquids by altering the amount of flavours and the combination in which they are used in production.

Heavy Metals Testing:

Many metals can be present in the device and potentially could enter into the aerosol, exposing the consumer to these metals. Standard testing of metals includes quantification of Hg, Ar, C, Pb, Cu, Sb, Mo, Co, V, Si, in addition to the five metals stated by the MHRA (Al, Cr, Fe, Ni, Sn). This approach targets all of the metals which are likely to be in the aerosol of most devices.

Nicotine testing:

This has been introduced to quality check the Nicotine used in the process at two stages, one from supplier (to check if Nicotine sold is fit for Human consumption) and Second from manufacture (to ensure that the correct amount is added to the final solution)

This is the most important ingredient of any E-Liquid and if not used correctly, potentially the most harmful. Unfortunately, there are many unscrupulous suppliers in the market who have been selling various forms of pesticides (that do contain certain amount of Nicotine) as Nicotine for human consumption. Needless to say, this had potentially deadly consequences.

Also manufactures will have increased responsibility on them to ensure that the correct amount has been added in every formulation to make sure that it reflects the potency claimed on the sales packaging.

TPD will address both the issues by having only licensed organisations selling wholesale Nicotine fit for human consumption and via detailed testing of final manufactured E-Liquid.

Manufacturing Conditions:

Like everything else that is manufactured for human consumption which has to adhere to strict hygiene conditions, E-Liquids are no different. Even more so in this case as the Vapours produced by them enter directly into the person’s lungs. Given that, the Sterilisation and the Sanitation of the environment where they are manufactured is of crucial importance. As any formulation is Liquid in nature, it’s is highly susceptible to absorb “Free Radicals” from its environment. It is of crucial and potentially life saving importance that E-Liquids are free from any such contaminants. Hence a laboratory of certain minimum ISO certification must be used in both manufacturing and bottling process.

This is a very important safety measure given the nature of the product. Anything we “Eat”, is processed by our body through our stomach which produces a very complex cocktail of enzymes to break down our food and digest it in the most efficient manner. But our Lungs and not designed to do so, they have very sensitive micro filters that may take very long time to get rid of any “outside” bodies that might enter them. Hence what we Vape has to be much safer and easy on lungs then compared to what we eat!

To Summarise:

The future of entire E-Cigarette depends on the premise that “Vaping is safer than Smoking” but in alarmingly high number of instances, it’s been found that this is not the case! Upon testing many liquids have been found to be extremely corrosive and harmful compared to traditional cigarettes or cigars!

As it directly impacts the public health, it’s a moral duty upon the Vaping industry to make sure they produce products that are safe and pose no harm to human health, TDP goes a long way in ensuring this.

At CHILLOHM UK, our genesis lies in pharmaceutical research and developments so we understand all the technicalities pose by TPD. All the Liquids manufactured by us are now TPD compliant and we can safely claim that they are fit for Human Consumption.

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