Post Brexit TPD and Electronic Cigarette Regulation
Now the news is full of talk of Brexit and the UKs exit from the European Union, now there are a number of implications of this for the UK vape industry and it’s not all bad, so regardless of your political leaning on the topic lets have a look at some of the potential rule and business changes that could affect electronic cigarette regulation.
Will TPD still apply?
Yes TPD will still apply, but how its implemented will change. Despite the TPD being a European Directive, it has been implemented into UK law, in statutory instrument 2016, No 507. So regardless of the outcome of Brexit it will still be a legally binding piece of legislation in the UK.
There will be some changes to the legislation to cover for the fact that we are no longer part of the EU and hence have no access to EU portal to upload product files and make notifications. The other interesting component is that the UK will also be free to make changes to the legislation as we feel we need to do and recent parliamentary debates have indicated an appetite to make these changes.
So we will make the distinction between regulatory changes and process changes, changes to the rules vs. changes to the way we comply with the rules.
So what might change from a regulatory standpoint, changes to the rules?
Mark Pawsey, MP for Rugby stood up in parliament on the 7th January 2019 and said the following.
‘There are three issues that are of concern to users in particular. The first is the cap on nicotine strength in vaping liquids. In many cases, it is too low to encourage heavy smokers to switch to e-cigarettes, which we know are far better for their health and which we want to encourage. There are restrictions on both the size of bottle in which vaping liquids can be sold and the tank size of vaping devices, both of which appear to be completely arbitrary, with no basis to them.
Both users of e-cigarettes and the manufacturing sector are hoping that this may be an opportunity for the Minister to rectify the regulations, which, frankly, are nonsensical. I look forward to the Minister’s response on those points.’
Mark who heads up the All Party Policy Group for vaping and has been instrumental in looking at the vaping industry and how regulations can impact on then will be pressing for regulatory changes post Brexit when the UK will no longer be required to follow EU directives on these issues. Of course any product that is exported to Europe will have to obey the rules there.
Cross boarder sales may be an area where we could face difficulty though, currently companies based in the UK can sell directly to consumers in other EU countries without registering there products, (some countries have opted out of this; Finland have opted out and Slovenia, Turkey, Iceland and Croatia have not confirmed if they will allow it), the rules require EEA or third countries to pre-register to allow cross boarder sales, this may not be allowed either following Brexit or if we make changes to our product rules.
For the moment, the technical rules for selling nicotine containing eliquids in the UK will not change following Brexit, but there is a strong possibility that it will change sometime after we leave the EU.
What might change from a processes perspective?
There are three main areas of concern that are immediately obvious, firstly it’s the local representative, under EU rules whilst you can import eliquids from outside the EU and can be registered by companies outside of the EU, it is a requirement to have a representative inside the EU that takes responsibility as the manufacture, for UK companies selling into Europe they will need to add a local company as the manufacture and provide contact details on the notifications.
The other key component and probably the most important component is the notification process, as indicated above we will no longer be able to use the EU portal to notify products for the UK market. Several things are going to happen and the MHRA are working in the background to develop a solution. But to the best of our knowledge this is what it is likely to look like: (please note this is open to change)
- The MHRA will develop their own portal for handling notifications.
- All companies will have to re-apply for submitter accounts on this new system
- Products will be sent up to the MHRAs portal
We have seen a schematic of the new proposed system and we have to say it does looks like a well thought out process and should not present much difficulty for companies used to using the EU portal moving over to using the new one. It also offers a system for small companies to do their own notifications.However, we are unable to share any details of what it will look like as its currently under embargo. As soon as the details are available we will publish a detailed guide for you.
What is the impact of these changes on companies? Well there are two key questions that we need to answer – will companies need to re-notify existing products (we are guessing no, as the logistics of this would cause the MHRA considerable concern in terms of data management) and will companies be able to update existing products through the new system (we are guessing yes, the alternative give the industry huge cause for concern)
Assuming the above the most obvious impact is that companies with products in both the UK and the EU will have to use two submission processing simultaneously, and that will raise some logistical obstacles. For those of us that have our own XML generator software, basic tweaks to the software will make this manageable, and should not raise costs too much, but its not un-forceable that companies will face additional burden and hence additional costs.
The next big issue is what happens when the EU and UK rules on electronic cigarettes start to diverge, which as discussed above is not only possible is likely, then companies will have a much increased burden, this is unavoidable, this is the fall out from Brexit, however the proposed changes we feel will be of benefit to the UK industry for its domestic products.
Also companies in Europe who wish to sell products in the UK will also face the same divergence.