Guidance Holes Filled

Paul
General

In a not too unsurprising move, the MHRA has recently updated its E-Cigarettes: regulations for consumer products guidance. This latest update has provoked a fair amount of discussion along with theories as to who (or whom) have been badgering either the Commission or the MHRA for “clarification”.

Let’s just say I have my suspicions on that and leave it there.

The update, rather innocuously, is in the “Further Information” section of the guidance page which seem intent on clarifying some definitions.

‘Electronic cigarette’ means a product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. E-cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges.

Seems straightforward enough so far. Though the term “electronic cigarette” – while a term used by many – isn’t the only term for the product. Unfortunately, in the eyes of the MHRA it’s the only term that is used.

Products that require a notification are limited to the e-cigarette product and component elements sold separately that specifically contain, or could contain, nicotine in the form of e-liquid. Therefore e-cigarette products such as disposable units and tanks will require a notification; however e-cigarette equipment such as mouthpieces, batteries and other elements that would qualify as an individual component will not.

Well this is interesting. On the face of that statement, any component part that specifically contains or could contain e-liquid as its intended use must now be notified. That would therefore include the Aspire Cleito extension glass (for the original Cleito) among other such clever solutions imposed by the 2ml (by volume) restriction.

It’s also clear in the Product Type guidance paper:

Individual parts of the electronic cigarette sold separately also fall within the scope of the TPD. These only need to be notified if these are essential elements of the electronic 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.

It could also, in theory apply to the Cleito skinny coils that can be used with the new Cleito EXO, which has a chunky coil as standard, but swap that for a skinny one and presto, you have a 4ml tank.

Replacement e-cigarette parts that could contain nicotine only require notification if they have not already been notified as part of a device or e-cigarette kit. Identical replacement parts that have already been notified as part of another notified e-cigarette product do not need to be separately re-notified if it is clear on the labelling what notified product the part is for. Any non-identical replacement part, particularly one that alters the consumer safety profile of a product (for example by changing its refill capacity), would require a separate notification.

Using the Cleito EXO and the original Cleito as my examples here, the coils for the original Cleito would not need to be notified twice as long as it is clear what product it is for (which it is), however the Cleito “Fat Boy” glass would need a notification as there isn’t an identical product that it can be used for (as far as I know).

But note the specific example the MHRA cite – for example by changing its refill capacity – which is exactly what the Cleito “Fat Boy” does. Same with the Nautilus X extension glass. There are other unique solutions out there that will now fall foul of this amended guidance

Someone, somewhere has “requested clarification” on these unique workarounds to the 2ml problem, and this is the result.

For those of you that use drippers or RTA’s exclusively, you haven’t been left out either:

Rebuildable devices come within the definition above and require notification.

Naturally, now that the implementation transition period is done, any new product now has to meet the stringent guidelines in the TRPR, so I suspect you can see parts for your drippers and RTA’s slowly but surely disappear from the authorised market.

Interestingly, on the guidance page is this snippet:

Products that do not meet the definition (such as disposable e-cigarettes that do not contain nicotine and 0% nicotine e-liquids) are out of scope of the TPD and do not have to meet its requirements.

We already knew that no-nic liquids were exempt from the TRPR, but the inclusion of no-nic disposables is fairly recent (as far as I am aware).

It would seem that there are active, ongoing discussions between various entities and as a result, the UK implementation of the TPD is becoming more restrictive.

So much for “light touch” regulation.

Quite.

(image credit TheBlackRhino/shutterstock.com)