Government response to the TPD consultation

[nanotm]

well the harmonisation idea seems ot have rather gone out the door on this one given the response, there claiming that the rest of the EU will do what it wants and were going to do it our way, but then lots of noises over the last few weeks have been suggesting that far from chasing better harmony the UK is edging closer to brexit whilst still keeping a toe in the pool, I rather suspect they will permit the selling of equipment "not for use with nicotine products" so long as they give the cover of "must not be sold for use with nicotine products" on the packaging,

the big thing will as you suggest be the refill containers, the proposal suggested they were looking at 10ml nic liquid bottles with a drip tip constructed of PET where the drip tip was not removable rather than the completely sealed tank units, and still allowing consumers to purchase unflavoured nic in the 20mg/10ml bottles at the shop (but I bet a moulded bottle will be a bugger to fill with a syringe) which would suggest there hoping people will stick that into their nic free 50ml juice bottles

[VapingBad]

Jan 8, 2016 15:08:45 GMT nanotm said:

well the harmonisation idea seems ot have rather gone out the door on this one given the response, there claiming that the rest of the EU will do what it wants and were going to do it our way, but then lots of noises over the last few weeks have been suggesting that far from chasing better harmony the UK is edging closer to brexit whilst still keeping a toe in the pool, I rather suspect they will permit the selling of equipment "not for use with nicotine products" so long as they give the cover of "must not be sold for use with nicotine products" on the packaging,

the big thing will as you suggest be the refill containers, the proposal suggested they were looking at 10ml nic liquid bottles with a drip tip constructed of PET where the drip tip was not removable rather than the completely sealed tank units, and still allowing consumers to purchase unflavoured nic in the 20mg/10ml bottles at the shop (but I bet a moulded bottle will be a bugger to fill with a syringe) which would suggest there hoping people will stick that into their nic free 50ml juice bottles

I don't believe that unremovable must mean one piece moulded bottles, they could be ratchet caps like all drinks but without the section the breaks easily.

[nanotm]

Jan 8, 2016 15:00:17 GMT yahoo2u2 said:

ZERO NIC juice will need to be tested FFS

it says notification only, that means you must pay £200 up front with some paperwork detailing your juice and then £60 a year to be allowed to market the stuff, the basic nic free juice only need be submitted for testing once (unless the formula changes) and if you change the formula you have to spend another 100£ on updating the notification page, making it a very cost effective way to get a new "safe" product to the market and have the consumer base know its safe

and the testing side was always going to happen once the FSA/LA figured out who's job it was to fund the testing (so it might be free for small businesses)

[nanotm]

Jan 8, 2016 15:13:48 GMT VapingBad said:

Jan 8, 2016 15:08:45 GMT nanotm said:

well the harmonisation idea seems ot have rather gone out the door on this one given the response, there claiming that the rest of the EU will do what it wants and were going to do it our way, but then lots of noises over the last few weeks have been suggesting that far from chasing better harmony the UK is edging closer to brexit whilst still keeping a toe in the pool, I rather suspect they will permit the selling of equipment "not for use with nicotine products" so long as they give the cover of "must not be sold for use with nicotine products" on the packaging,

the big thing will as you suggest be the refill containers, the proposal suggested they were looking at 10ml nic liquid bottles with a drip tip constructed of PET where the drip tip was not removable rather than the completely sealed tank units, and still allowing consumers to purchase unflavoured nic in the 20mg/10ml bottles at the shop (but I bet a moulded bottle will be a bugger to fill with a syringe) which would suggest there hoping people will stick that into their nic free 50ml juice bottles

I don't believe that unremovable must mean one piece moulded bottles, they could be ratchet caps like all drinks but without the section the breaks easily.

I was just going by the picture I saw on one of the EU tpd pages it had a blow moulded bottle which included the tip as part of its construction and a secondary picture with he push fit button top ones with a red line through them, I suspect that is because a certain pharma company has a patent on that particular bottle not that it will mean anything, as soon as I got it home I'd chop the top off and put it in a decent container ......

but given how much of the regulations they have opted to side step (at least for now) then I expect you could be right

[yahoo2u2]

For EACH juice and variation of that juice.

0 nic, 3mg, 6mg, 9mg, 12mg, 18mg = £1200 per juice.

If a supplier changes the flavour start again

Unless, I am reading this wrong.

[majorhazzard]

I just received this email...

A public consultation on the proposed introduction of fees to recover the cost of MHRA’s regulatory activity for E-Cigarettes under the revised EU Tobacco Products Directive has been launched today at the following link:


www.gov.uk/government/consultations/regulatory-fees-for-e-cigarettes




The consultation will run for three weeks only and we would be grateful for responses to be sent to [e-mail] by close of business on 29 January 2016 please. Unfortunately due to the very tight timelines we are working to, it will not be possible to entertain any late submissions. A response proforma is contained within the consultation document.

[nanotm]

Jan 8, 2016 15:19:35 GMT yahoo2u2 said:

For EACH juice and variation of that juice.

0 nic, 3mg, 6mg, 9mg, 12mg, 18mg = £1200 per juice.

If a supplier changes the flavour start again

Unless, I am reading this wrong.

only the person mixing the juice has to file the paperwork, if the formula changes due to supplier changes then you submit a variation notice which is £100, exactly how the version definition will be broken down will be divulged later but from the looks of the documents relased this far it would appear you would only need to supply 1 notification per formula and then add the words "various nic levels from zero to 20mg", if for instance your juice is 50/50 then that isn't going to change because you added some nic to it, your juice will just have some nic in it, the concentrate mix will still be the same % the vg and pg will be the same % giving the same total % of each thing regardless of the nic strength (how you mix it up might vary but not by much)

the notification system seems geared directly at making sure SME's can afford it by keeping it cheap and simple

[sydsut]

Jan 8, 2016 15:32:52 GMT nanotm said:

Jan 8, 2016 15:19:35 GMT yahoo2u2 said:

For EACH juice and variation of that juice.

0 nic, 3mg, 6mg, 9mg, 12mg, 18mg = £1200 per juice.

If a supplier changes the flavour start again

Unless, I am reading this wrong.

only the person mixing the juice has to file the paperwork, if the formula changes due to supplier changes then you submit a variation notice which is £100, exactly how the version definition will be broken down will be divulged later but from the looks of the documents relased this far it would appear you would only need to supply 1 notification per formula and then add the words "various nic levels from zero to 20mg", if for instance your juice is 50/50 then that isn't going to change because you added some nic to it, your juice will just have some nic in it, the concentrate mix will still be the same % the vg and pg will be the same % giving the same total % of each thing regardless of the nic strength (how you mix it up might vary but not by much)

the notification system seems geared directly at making sure SME's can afford it by keeping it cheap and simple

How will this affect those companies like Joose Juice who can mix to order, ie different PG/VG ratios and extra flavourings etc.

[robby]

Poll added for interest

[nanotm]

Jan 8, 2016 15:25:17 GMT majorhazzard said:

I just received this email...

A public consultation on the proposed introduction of fees to recover the cost of MHRA’s regulatory activity for E-Cigarettes under the revised EU Tobacco Products Directive has been launched today at the following link:


www.gov.uk/government/consultations/regulatory-fees-for-e-cigarettes




The consultation will run for three weeks only and we would be grateful for responses to be sent to [e-mail] by close of business on 29 January 2016 please. Unfortunately due to the very tight timelines we are working to, it will not be possible to entertain any late submissions. A response proforma is contained within the consultation document.

damn they will require product notifications for all tanks

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

at least there not going to ask for notifications for all the spare parts or indeed for the mod's well that makes it better to a degree, although just exactly how are they planning to get the likes of aspire ismoka or smok or kanger etc to comply it might be a good idea if they were to contact those companies directly to get their input, I suspect this will lead to a contraction in the number of products being marketed and certainly in the number of vape shops that are direct importing gear from overseas if the manufacturers wont fund the registrations.

[nanotm]

Jan 8, 2016 15:48:03 GMT sydsut said:

Jan 8, 2016 15:32:52 GMT nanotm said:

only the person mixing the juice has to file the paperwork, if the formula changes due to supplier changes then you submit a variation notice which is £100, exactly how the version definition will be broken down will be divulged later but from the looks of the documents relased this far it would appear you would only need to supply 1 notification per formula and then add the words "various nic levels from zero to 20mg", if for instance your juice is 50/50 then that isn't going to change because you added some nic to it, your juice will just have some nic in it, the concentrate mix will still be the same % the vg and pg will be the same % giving the same total % of each thing regardless of the nic strength (how you mix it up might vary but not by much)

the notification system seems geared directly at making sure SME's can afford it by keeping it cheap and simple

How will this affect those companies like Joose Juice who can mix to order, ie different PG/VG ratios and extra flavourings etc.

they will need to fill out the notification consultation to get that clarified, but the current direction would appear to suggest that every fixed % would require a notification page .... utterly ridiculous (the only thing should be the concentrate mix with a vg/pg range from 100/0>0/100% mixes but the pharma companies wont wear that), another option for them would be to make up the concentrate and supply the nic as a flavourless "one shot"

[nanotm]

Jan 8, 2016 15:56:58 GMT nanotm said:

Jan 8, 2016 15:48:03 GMT sydsut said:

How will this affect those companies like Joose Juice who can mix to order, ie different PG/VG ratios and extra flavourings etc.

they will need to fill out the notification consultation to get that clarified, but the current direction would appear to suggest that every fixed % would require a notification page .... utterly ridiculous (the only thing should be the concentrate mix with a vg/pg range from 100/0>0/100% mixes but the pharma companies wont wear that), another option for them would be to make up the concentrate and supply the nic as a flavourless "one shot"

actually there could be another way round this, they could do 1 notification for the flavour mix, one each for vg/nic and pg/nic and none for the vg/pg "filler" then supply an empty bottle of the right size (30ml/50ml/100ml) the filler and the concentrate are "unregulated" in terms of size because of zero nic, the instructions are then supplied with the kit to pour the various parts into the supplied container and leave in the cupboard for a week, that way the % variations don't require new notification filings for each variation supplied and they don't need to stop offering the bespoke service

theres probably rom within the current consultation on the costs and amount of filings to be made though to ensure the simpler approach is taken that allows the formula to specify nothing more than flavour % used with pg/vg ranged from 0/100>100/0 and nic ranged from 0>20mg/ml which will reduce t he workload and staffing costs for the MHRA and still provide the actual service required by uk consumers at a cost the company can bear without massively affecting their operating costs.

[everythingliquid]

Jan 8, 2016 15:00:17 GMT yahoo2u2 said:

ZERO NIC juice will need to be tested FFS

Correct, however this will be to show that the juice contains no nicotine.

Today has been a huge step forward for a lot of manufacturers.  Consider that MHRA fee's were originally estimated between 5 - 10k per flavour this money can now be put towards product testing, meaning that a much larger percentage of SMB's will have a fair crack at getting through the directive.

An extended deadline to sell off old stock will allow suppliers who can't afford to get through more time to budget for testing, shop keepers will have had a huge weight lifted from their shoulders.

For us, the majority of our business is from dealing with SMBs and start ups.  This allows us time to really nail down the finer points and bring more manufacturers past the TPD.

A brilliant start to the year and awesome end to the week!

[yahoo2u2]

Just has a message from a vendor who says that YES all nic variations will need to be tested and paid for. Not sure yet on if its a VAT full of the stuff, if so I can see some making huge vats of juice and paying for one test, but if nic levels are to be tested then that adds another layer to the costs.

The end user will of course pay for it, but I think that many small juice makers may struggle to offer the ranges they do.

[pipeman01]

The upside of this is that there will be better quality control of juice in the marketplace and hopefully this will lead to consistency of flavor as I'm sure that sometimes flavors are tweaked and what you like has had a subtle change and aren't as nice as they used to be (or maybe they are better)