TPD Compliant

WHAT IS TPD?

 

 

On the 20th May 2016, the Tobacco and Related Products Regulations implemented TPD2 (Tobacco Products Directive).
This regulation set out the requirements for nicotine-containing e-cigarettes and refill containers (e-liquids). There has been a transitional period of 12 months where manufacturers and retailers can prepare for the regulation to come into full effect (See timeline below).

Realistically, the vape industry had to be regulated at some stage, in order to protect consumers from bad vape products, as well as e-liquids containing substances that could potentially cause harm. The TPD legislation does do this, unfortunately, it also goes beyond just consumer protection and restricts products at a level that makes it difficult and confusing to sell e-cigarettes.
Thus leaving many consumers falsely disillusioned as to whether they should be taking the proven 95% safer alternative to smoking. With this said there is little gained from kicking and screaming, let’s look at the positives and hope that we can achieve a sensible, unbiased approach on any future regulation.

 

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WHAT DO THE NEW TPD RULES ENFORCE?

• A minimum standard for the safety and quality of e-cigarettes and e-liquids.

• The availability of information for the customer so that they can make an informed decision.

• Fostering an environment that looks to discourage children from starting to use these products.

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TPD TIMELINE

20th May 2016

• Advertisement for vape related products is illegal.

• Sales to other EU countries are prohibited without necessary registration.

• Non-compliant stock can still be manufactured, bought and sold.

• Most retailers will still be selling non-compliant products as usual, so consumers will be largely unaffected. However, some small producers will close down as they realise that TPD compliance is not viable.

20th November 2016

• Retailers have six months to clear their shelves of non-compliant stock

• New non-compliant stock cannot be manufactured, purchased or sold.

20th May 2017

• It is now illegal to sell any non-compliant product. Only products tested and MHRA notified up to six months earlier can be sold with correct CLP (Classification, Labelling and Packaging).

• With the sell-through period coming to an end on 19th May 2017, failure to meet these requirements has consequences for retailers and producers.

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REGULATIONS FOR TPD RETAILERS

• As a retailer, you do not need to submit information for any products you sell, unless you qualify as a producer.

• You have until 19th May 2017 to sell any stock of products that do not comply with the labelling and product composition requirements of the TPD. After this date, it is your responsibility to ensure any new products you purchase are compliant with the TPD. The MHRA will publish a link to a web page where you can check for all products which are compliant.

REGULATIONS FOR TPD PRODUCERS

The regulations define a producer as:

“Anyone who manufactures or imports these products or who re-brands any product as their own.”

• If you are a producer, you are required to submit information about your products to the MHRA through the EU-CEG (European Common Entry Gate) notification portal.

• The MHRA has uploaded the first products which have been submitted. However, they are keen to stress they have not checked each notification for completeness or that these products are TPD compliant.

WHAT ABOUT THE CONSUMER?

There will inevitably be some changes to the products we see in stores, initially, there will be less available, as retailers sell off the existing non-compliant
stock and convert to compliant stock. Some liquids will also cease to exist on the market as manufacturers decide whether to proceed with testing and compliance.

E-liquid will only be available in 10ml bottles moving forward, with a maximum strength of 20mg (realistically, manufacturers aren’t likely to produce liquids over 18mg,to allow some margin for error). E-liquid with no nicotine (0mg) does not need to be tested and is unaffected by the TPD. So we may see an increase in 0mg lines where nicotine can be added ‘optionally’.

Only tanks with a capacity of 2ml and below will be available. Tanks must also be ‘leak proof’ at the point of refilling’ and deliver a ‘consistent dose of nicotine’.

Thankfully, the TPD has focused on the e-liquid bottle, rather than the tank, when defining what ‘leak proof’ refilling’ means. New tanks designed to fill via a small hole that the nozzle of an e-liquid bottle fits snugly into should suffice.

Manufacturers are just starting to release these ‘top-hole’ tanks that should satisfy the TPD’s criteria. At the moment they are only addressing the higher end sub-ohm type market. However, over the coming months, we are confident that we will see a diverse range of tanks available.
On the ‘consistent dose of nicotine’ issue, it looks as if there will be some leniency in interpretation. As long as the tanks deliver a reasonably consistent nicotine dose in lab conditions (which sidesteps un-quantifiable, real-world variables, such as how hard or long a user inhales),they will be fine.

As far as we can see, batteries, mods and RDA’s sold ‘without a tank’ should be unaffected by the TPD. This is because they are not capable, in isolation, of vapourising e-liquid. However, if a battery and tank are sold together as a kit, the whole kit would need to be compliant.

After May 20 we will likely see a lot ‘TPD compliant’ kits as well as new versions of the tanks we know already,
adapted (Probably reduced capacity, with an “optional glass”) in order to be compliant at the point of sale.

Let’s take a closer look at how the TPD will affect vaping.

ECIDs:
Every e-cigarette kit, tank, cartridge and nicotine containing e-liquid will need an ECID number to be placed on the market within the European Union. To get an ECID, products must be tested and analyzed to make sure they comply with article 20 of the TPD and are safe to use. ECIDs will be issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.

E-Liquid with Nicotine:
All nicotine containing e-liquid will be limited to 10ml bottles and 20mg nicotine strength. Also, it is predicted that the cost of nicotine containing e-liquid will rise following the implementation of the TPD. This is because all e-liquid manufacturers will have to get an ECID for every flavour in every strength. The cost of getting one e-liquid ECID is predicted to be between £3000 and £10000. This additional cost is likely to be passed onto the consumer.

E-Liquid without Nicotine:
Nicotine free e-liquid is not affected by the TPD.

Flavour Concentrates:
Flavour concentrates are not affected by the TPD.

Propylene Glycol and Vegetable Glycerine:
PG and VG are not affected by the TPD.

Nicotine Concentrate:
The TPD rules clearly state that nicotine containing liquid can only be sold to consumers in 10ml bottles and can be no stronger than 20mg. However, this does not apply to trade sales. We are planning on setting up a wholesale area of our website that will allow those wanting to purchase nicotine concentrate at 72mg for commercial purposes to do so. This means that we will stop selling our 50ml, 100ml and 250ml bottles of nicotine concentrate and only provide 72mg nicotine concentrate to trade customers in bottle sizes of 500ml and above. For end users, we will soon start to provide 'Nicotine Shots' for those vaping at 6mg or less, and 'Just Add Flavour' bottles of nicotine base liquid for those who vape e liquid at above 6mg. We plan to sell these nicotine solutions at the lowest price possible so that the cost benefits of DIY e liquid can still be maintained. If you are worried about the future of DIY e liquid - don't be! We have looked extensively into the TPD and its effects on DIY e liquid and we feel that the future is bright. Pre-mixed e liquid will become more standardised and there will be a lot less choice for vapers. This is because testing is very expensive and a lot of small e liquid manufactures will simply not be able to afford it. Instead, we expect to see a lot of current e liquid manufactures moving into making flavour concentrates so that their products can remain on the market, meaning that DIY vapers can experience many more exciting flavours and still save a whole load of cash!

E-Cigarette Kits:
Any e-cigarette kit containing a tank and/or e-liquid will need to be tested and receive an ECID as a kit. It is likely that kits will become less common and individual items will be sold separately.

Batteries and Mods:
Batteries and mods do not need ECIDs unless they are part of a kit. However, the advertising of batteries and mods is restricted.

Cartridges:
Pre-filled cartridges will still be available as long as they hold no more than 2ml of e-liquid.

Tanks:
Like cartridges, tanks will be limited to a 2ml e-liquid capacity. Also, they will need to have a ‘leak free’ filling system. This issue of ‘leak free’ filling systems was a concern to vapers and manufacturers when first announced, but it appears that many top-fill tanks will be compliant with this regulation.

Coil Heads:
Coil heads will be tested as part of the tank. If the tank meets the TPD requirements then the coil heads for that tank will be available for sale. If a tank has coil heads in multiple resistances, then each resistance will need to be tested.

RTAs:
RTAs as we know them are likely to disappear from the market as it is impossible to test a tank that has no coil and wick installed. However, it is likely that RTAs will start to be manufactured with rebuildable coil heads. This allows the products to be tested and vapers to make their own coils.

RDAs:
Unfortunately, RDAs are unlikely to meet the requirements of the TPD as they do not have leak free filling systems. It appears that RDAs will no longer be legally available in the EU after May 2017.

Battery Cells:
High drain battery cells are not affected by the TPD.

Wicks and Wire:
All types of wire and wicking materials are not affected by the TPD.

Advertising:
Vaping products affected by the TPD will no longer be able to be promoted from May 2016. This restriction does not apply to posters or billboard advertising. Sponsorship by e-cigarette companies is also prohibited. However, the UK Government has drawn a line between promotional and information material. Example: ELFC will still be able to promote our flavour concentrates in any way we wish as they are not affected by the TPD, but we will only be able to inform you about the strength, bottle size, directions of use etc. of our nicotine concentrate. Customers should still receive emails from their favourite e-liquid and hardware retailers regarding new products.

As with any piece of legislation, the TPD could be changed or updated in the future. ELFC will always try to keep our customers informed about any regulation change that could affect our services or the vaping industry. If you have any further questions about the TPD, feel free to get in touch at 

 

There are also TPD rules regarding e-liquid compliance. Manufacturers must adhere to the following rules for their merchandise to remain TPD compliant:

• The capacity of the bottle mustn’t be greater than 10ml

• The strength of the nicotine mustn’t be greater than 20mg/ml

• All bottles need childproof caps as well as nozzles which limit the liquid flow

• Nicotine warning stickers must be displayed on all bottles

• Boxes of e-liquids have to include informational and warning leaflets

From the customer’s point of view, only the first two of these rules are relevant, since they restrict the strength and size of e-liquid bottles.

 

These restrictions outlined here are those which have a direct effect on vapers, however, there are more regulations which impact on vape manufacturers.

Some key changes that vaping companies need to know:

• A 6-month notification is required for all new products. Companies must notify the regulatory agencies in their country 6 months before being permitted to sell new products. Many countries don’t enforce this rule, however, it has slowed down innovation within the industry while also reducing the products which are available for vapers to buy.

• E-liquid emission testing. For manufacturers, this may be an extra hassle however for consumers, it’s quite a good thing. While it’s costly, it has increased confidence in e-juice quality and has helped to combat the argument about not knowing what goes into e-liquid.

• Advertising restrictions. Many countries have outlawed advertising on radio and TV, with social media and online promotions, product placement deals and newspaper advertisements also prohibited.