We've recently posted a blog post on the TPD regulations. I'm not able to post links here so I've no other choice than to copy and paste it here. You can find similar information relating to e-cigarettes on our Ashtray Blog.
The EU Tobacco Products Directive: What Retailers and Shop Owners need to know
A few retailers have asked me how the EU regulations on e-cigs will affect them.
If you’re not heard of the TPD before, it’s part of the Tobacco Products Directive (article 20). 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. Only last week I was told menthol e-liquid is going to be banned. (It’s not!)
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!
Do note that legislation in the UK has not yet been finalised. The information here represents what we know now.
We’ll keep this post updated, so feel free to send questions through (contact detailshere!) or leave a comment under this post.
(Protest is still continuing against the TPD. If you want to get involved, details of the next even can be foundhere.)
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.
2. As a retailer, will my shop need any form of Special Licence or Insurance under the TPD?
No. 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
additionalproduct 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 restrictionshere, and an illustrated guide to battery safetyhere.
4. What is going to happen with imported liquids – can we still sell them?
E-Liquid now has to be made with EU or USA pharma grade nicotine. At present this excludes Chinese manufacturers, and until recently we have not seen any making efforts to comply.
In addition, e-liquids will need to undergo testing, including emissions testing, with a submission being made 6 months before sale is allowed.
It’s possible that some of the larger USA e-liquid companies will be prepared to fork out for compliance, notifications and emissions testing. However, the majority of companies we’ve spoken to know little about the TPD.
5. So, the new regulations stipulates 2ml Cartridge, does that then now include Refiller/Rebuildable/Dripper Tanks?
Unfortunately so. One government document appeared to suggest tanks would be excluded, however the restriction on tanks was clarified in the2015 ECig Summit. However, we’re not sure to what extent it will affect parts for rebuildable clearomisers.
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 to the MHRA. 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. Why is the MHRA consulting about costs? Will I now have pay a fee to sell e-cigs?
The MHRA plans to charge manufacturers and importers fees to cover the costs of receiving and reviewing submissions.
The proposed fees are:
- Submitting a new product: £220 per sku
- Service fee: £60
- Modification fee: £110
These are not set in stone. The MHRA are currently consulting on the costs. We believe they have underestimated the revenue likely to be generated by submissions, and there is the potential to have these costs reduced.
These costs will only affect you if you are a manufacturer or an importer.
8. What is going to happen with batteries, box mods, variable voltage and wattage devices?
Batteries and mods will not be affected by the legislation.
9. What about clearomisers and rebuildable devices?
All clearomisers 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. Companies like Japan Tobacco are assuming that these existing standards will be applied.
However, there are additional requirements:
- E-liquids must have a 1cm long nozzle, and emit no more than 20 drops of refill liquid per minute when placed vertically
- There needs to be a docking mechanism for the refill mechanism.
Our current understanding is these requirements are an either/or.
However, there is still uncertainty around the implementation of the leak free refilling part of the TPD. There are also rumours that the UK government is challenging the need for a docking mechanism.
10. Do you know of any particular signage I need to display in my store from May 20h 2016?
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 on our blog. Get in touch to request posters and logs.
11. After May 20th 2016, how long do we have to implement the TPD?
You can continue to sell existing products until October 20th. If you submit notifications for existing products, you can continue to sell them until May 20th.
Vaping products after May 20 will have to be compliant with the EU TPD, and have been notified 6 months prior to selling.
12. 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.
13. What other restrictions will there be on e-liquid?
Glass bottles will no longer be allowed. E-liquid will be restricted to 10ml bottles, and 2% will be the maximum strength allowed.
13. How will we advertise?
Advertising will be severely restricted, although again the UK has taken a very minimalist approach to implementing the TPD. We’ll be covering the restrictions (and how to thrive under them) in a later post, but here’s a quick summary:
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
- marketing emails
- online promotions
- social media marketing
Keep Your Chin Up!
The EU TPD isvery 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. As a result, we are likely to have one of the most liberal interpretations of the TPD in the EU.
While the restrictions will increase costs and choice, and reduce the pace of innovation, it’s NOT the end of the British e-cig industry.
More Information
We’ll update the post as:
- information becomes clarified
- as more questions come through
Do let us know any unanswered questions you have!
