The EU Tobacco Products Directive (TPD): What Vape Retailers and Shop Owners Need To Know
A few retailers have asked me how EU e-cig regulations will affect them.
If you've not heard of TPD II before, it's refers to the Tobacco Products Directive (article 20 being the section that affects e-cigarettes). Although designed for cigarettes, e-cigarettes were included in the badly written and designed article 20.
Numerous rumours are swirling around - many of them hopelessly wrong. One week I was told menthol e-liquid is going to be banned. (It's not, although we'll need to watch that doesn't happen in TPD III!)
Last week one of our resellers sent us through a comprehensive list of questions, which both spurred me into action and steered the format of this post!
We’ll keep this post updated, so feel free to send questions through (contact details here!) or leave a comment under this post.
1. Are e-cigs now medicalised?
No. Thanks to the efforts of dedicated vaping activists, the EU’s attempt to medicalise e-cigs was defeated.While companies have the option to go for a medical license, this is not mandatory. In any case, the costs are beyond the resources of small to medium sized companies, and daunting even for larger companies, with only BAT achieving a medical e-cig so far.
2. As an e-cig retailer, will my shop need any form of Special Licence or Insurance under the TPD?
No license is or will be required to sell e-cigs, vape pens or e-liquid. However, we always recommend you have insurance, and buy from suppliers which have product liability insurance.
3. Besides product knowledge, would I or my staff need any extra training to sell e-cigs?
You do not need any additional product knowledge or training. However, you should already have a knowledge of General Products Safety Regulations (2005). Do be careful to follow age restriction guidelines. Failure to do so could lead to a ban on selling nicotine. We’d also advise a good knowledge of battery safety info. We have put together a guide to compliance with age restrictions here, and an illustrated guide to battery safety here.
4. What is going to happen with imported liquids - can we still sell them?
It was our original understanding that E-Liquid now has to be made with EU or USA pharma grade nicotine. We haven't seen any mention of that in UK government legislation, and are seeking clarification.
E-liquids will need to undergo testing, including emissions testing, with a submission being made 6 months before sale is allowed. This is likely to lead to a massive slow down in the rate of innovation of nicotine containing e-liquids. However, zero nicotine e-liquids will not be affected.
As of March 2017 we are seeing a number of compliant e-liquids coming through from the USA. The TPD does mean there is likely to be continued consolidation in the e-liquid market, with larger, more established e-liquids becoming more dominant.
5. So, the new regulations stipulates 2ml Cartridge, does that then now include Refill/Rebuildable/Dripper Tanks?
Unfortunately so, at least in the UK. One government document originally appeared to suggest tanks would be excluded, however the restriction on tanks was clarified in the 2015 ECig Summit.
However, we’re not sure to what extent it will affect parts for rebuildable tanks. This isn't universal. In France, the regulations have been interpreted as applying only to single use e-cigs and disposable cartridges. Unfortunately, the UK government sought clarification on this from the EU and was told categorically that this is not allowed.
6. As a retailer, do I need to carry out testing and submit notifications?
The onus for testing and submissions falls on the manufacturer and the importer. If you are importing the devices, you will need to conduct the tests and submit notifications - see here for details.
Do note that submissions should be made 6 months before going to market. Given the costs of both testing and notification, this is not likely to be feasible for smaller retailers, especially those carrying a wide range of stock.
If you are not importing or manufacturing, you will not have to conduct tests or notify products.
7. Will I now have pay a fee to sell e-cigs?
The MHRA charges manufacturers and importers fees to cover the costs of receiving and reviewing submissions.
The fees (per sku) are:
- Notification Fee: £150
- Annual Fee: £60
- Substantial Modification Fee: £80
There may be a reduction in costs, as the MHRA has received many more applications than anticipated, potentially allowing it to employ economies of scale.
If that seems expensive, consider that in Belgium the authorities are charging £4,000 a sku.
8. What is going to happen with batteries, box mods, variable voltage and wattage devices?
Batteries and vape mods will not be affected by the legislation. However, it will be frustrating to use powerful mods with new tanks because of the constant refilling needed.(We've tried sub-ohming with new, TPD compliant tanks. While the vape is excellent, it does entail frequent refilling!)
9. What about vape tanks?
All vape tanks will have to undergo emissions testing. Manufacturers and importers will need to submit them to the MHRA 6 months before being put on the market.
There is also a leak free refilling requirement.
Existing standards for leak free refilling are fairly simple. For example, to check if a container has leaked, you simply wipe the container and see if there is liquid on the outside.
However, E-liquids must have a 1cm long nozzle, and emit no more than 20 drops of refill liquid per minute when placed vertically have has a docking mechanism. (See Tobacco and Electronic Cigarettes Product Regulations: Part 6 for details).
10. Do rebuildable electronic cigarettes fill under the TPD/TPPR?
Originally there was some confusion over this, and the situation remains unclear. In an email forwarded to me, the MHRA recently stated that:
"Individual parts of the electronic cigarette sold separately also fall under the scope of the TPD. These only need to be notified if these are essential elements of the e-cigarette and capable of containing nicotine. This would include the tank, atomiser or cartridge but would exclude other components such as replacement batteries or mouthpieces."
This contradicts information given to us elsewhere.
11. Why are some shops still selling larger tanks/ e-liquid bottles?
IF the tanks are over 2ml they are breaking the law. TPD II does not apply to nicotine-free e-liquid, so larger bottles such as shortfills, which do not contain nicotine, can still be sold.
12. What are the penalties for non-compliance?
Penalties include stiff fines, confiscation of products and up to 6 months in prison.
13. Do you know of any particular signage I need to display in my store from May 20th 2017?
No.However, you already need to comply with age restrictions guidelines, which includes a requirement to display age posters. You can find a guide to compliance here, and you can also request posters and log books by emailing [email protected].
14. How long do we have to implement the TPD?
If you have submitted notifications for existing products, you can continue to sell them until May 20th 2017.Vaping products after May 20th 2017 will have to be compliant with the EU TPD, and have been notified 6 months prior to selling.
15. I've also heard only Tobacco flavours can be sold, and there will be no more "Flavours".
Countries have the option to ban flavours other than tobacco. However, the UK has chosen not to take these options.
16. What other restrictions will there be on e-liquid under the TPD?
Glass bottles will probably no longer be feasible. E-liquid will be restricted to 10ml bottles, and 2% will be the maximum strength allowed. E-liquid must be supplied with a warning that nicotine is highly addictive, and with an information leaflet.Ironically, the warning must also be applied to tanks which do not contain nicotine. Trading Standards has insisted on an additional line underneath the warning. This clarifies that the warning only applies when used with nicotine containing liquids.
17. How will the vape industry advertise?
Advertising will be severely restricted, although again the UK has taken a very minimalist approach to implementing the TPD.
What’s allowed:
- online tutorials and information
- trade shows
- trade magazines
- leaflets/posters
- billboards
What’s not allowed:
- tv/radio advertising
- product placement
- newspapers/periodicals/magazines
- 'cold' marketing emails
- online promotions
- social media marketing (but tutorials, blog posts e.t.c. are allowed)
18. What other regulations are there on e-cigarette advertising?
Even when you can advertise, there are plenty of regulations on what you can and can't do.
- E-cigarette advertising can not make any health claims (but this rule is under review and likely to change.) As of November 2018, health claims can be made for vaping, but with some severe caveats. See UK Allows Health Claims For Vaping for details
- E-cigarette advertising must not be associated in any way with a tobacco brand or be seen to be promoting a tobacco product or showing tobacco products in a positive light.
- Advertising must be socially responsible.
- Adverts must make it clear the product is an e-cigarette, not a tobacco product.
- Adverts may not quote health professionals.
- Adverts must state if the product contains nicotine.
- Adverts may not encourage non-smokers/non-nicotine users to use e-cigs or be designed to appeal to people under the age of 18.
- People who have a major role/are using an e-cigarette in an e-cig advert must not appear to be under the age of 25.
19. Can retailers still run special offers and promotions under article 20 of the TPD?
The TPD appears to be focussed on the language of marketing rather than prohibiting offers. Specifically, it states that that retailers should avoid "highlighting price promotion", but it does not state you should not run price promotions. Information can be shared, and some retailers will argue that price drops are information.
20. Can I still advertise my shop?
Some media outlets have taken the view that the restrictions only apply to e-cigarettes - not to vape shops. However, it's worth noting that the restrictions call for a ban on advertising that lead to direct or indirect promotion of electronic cigarettes or refill containers.
So the situation is currently confused. But it's worth noting that in their recent consultation on e-cig advertising, CAP wrote:
"...e-cigarette businesses may, all other factors being equal, lawfully advertise their existence in media where they cannot lawfully advertise products."
Source: Changes to the regulations of e-cigarette advertising.
Don't give up!
These may seem like draconian regulations, but you can still thrive! See our post below for tips from experts...https://www.ecigarettedirect.co.uk/ashtray-blog/2016/05/e-cig-store-marketing-tips.html
Keep Your Chin Up!
The EU TPD is very poor legislation.
It was so badly conceived that the scientists quoted by the commission wrote en masse that their studies had been misinterpreted.
Fortunately, the UK government has been understanding. In fact, one government minister has promised e-cig regulation will be more 'Italian' than traditionally British. As a result, we have one of the most liberal interpretations of the TPD in the EU.
While the restrictions will increase costs and decrease choice, and reduce the pace of innovation, it's NOT the end of the British e-cig industry.
More Information
We’ll update this post as:
- information becomes clarified
- as more questions come through
Do let us know any unanswered questions you have!
