Updated 7 February 2014 to include related fiasco over smokeless tobacco flavours.
Updated 17 February 2014 to reflect correction of anomaly for e-cigarettes in lawyer linguist editing of the text (based on leaked unpublished work in progress document)
Whoops! A comment left by ‘godek’ spotted the following in the text of the text of the Tobacco Products Directive as it applies to e-cigarettes:
Article 18 – paragraph 4
4. Member States shall require manufacturers and importers to ensure that:
(a)[…]
(b) unit packets and any outside packaging of electronic cigarettes and refill containers:
i. include a list of all ingredients contained in the product in descending order, and an indication of nicotine content and delivery per dose, the batch number and a recommendation to keep out of reach of children;
ii. do not include elements or features referred to in Article 12, with the exception of paragraph 1(a) of Article 12 concerning the nicotine content;
Then cross reference to Article 12, which controls description on tobacco products – and is written to support the ban on flavours in tobacco products.
Article 12
Product presentation
1. The labelling of a unit packet and any outside packaging and the tobacco product itself shall not include any element or feature that:
(a) promotes a tobacco product or encourages its consumption by creating an erroneous impression about its characteristics, health effects, hazards or emissions; labels shall not include any information about nicotine, tar or carbon monoxide content;
(b) […]
(c) refers to taste, smell, any flavourings or other additives or the absence thereof;
Oh dear. As 12.1(c) is not exempted in the reference from 18.4(b)ii it looks like it will be illegal to add any ‘element or feature’ to e-cigarette or refill container packaging that refers to flavourings – even though flavourings will be permitted (unless banned by members states). But recital 13 establishes the following worthy and sensible aim:
The greatest possible transparency of product information should be ensured for the general public…
…but not to the point of saying what the flavour is? How will producers of flavoured electronic cigarettes and refill containers label their these products? How will users know what they are buying, storing and using…? How will vendors know which product is which at the point of sale and when in stock? Or does it amount to a de facto ban through chaos and confusion?
Update 17 February 2014: looks like they’ve fixed this – key changes are highlighted. I think they noticed that the requirement to list the ingredients (i) was inconsistent with not saying what the flavour is (ii) so the text has been amended during the ‘lawyer-linguist’ polishing of the sacred steaming turd:
Article 18.4 updated
4. Member States shall require manufacturers and importers to ensure that:
(a)[…]
(b) unit packets and any outside packaging of electronic cigarettes and refill containers:
i. include a list of all ingredients contained in the product in descending order of the weight, and an indication of the nicotine content of the product and the delivery per dose, the batch number and a recommendation to keep the product out of reach of children;
ii. without prejudice to point b(i), do not include elements or features referred to in Article 12, with the exception of Article 12(1)(a) and (c) concerning information on the nicotine content and flavourings;
iii. […]
Smokeless (and some other) tobacco products
Updated 7/2/14 This mess also applied to tobacco products , including smokeless tobacco… update 17/2/14 and this has not been fixed in the lawyer linguist exercise so far. Again smokeless tobacco products are far safer alternatives to smoking, but rely for their appeal in part on flavours. It is good that flavours will be allowed, but ridiculous that saying so on the packaging will be banned. The construction of Article 6 allows for flavours in tobacco products other than cigarettes and roll-your own tobacco (ie. including smokeless, pipe tobacco, cigars etc):
Article 6
6.1. Member States shall prohibit the placing on the market of tobacco products with a characterising flavour.
6. 10.Tobacco products other than cigarettes and roll-your-own tobacco shall be exempted from the prohibitions laid down in paragraphs 1 and 5.
But then Article 12, which bans descriptions that include flavours, refers to all tobacco products:
Article 12
Product presentation
1. The labelling of a unit packet and any outside packaging and the tobacco product itself shall not include any element or feature that:
…(c) refers to taste, smell, any flavourings or other additives or the absence thereof;
I doubt this is deliberate – it would be unbelievably stupid or cynical if it was. It is more likely a consequence of making rushed legislation and using the short-cut of cross-referencing to provisions that were designed for entirely different products. It’s very hard for anyone to hold all of those different article in their head simultaneous, but writing legislation in this way makes the negotiators more vulnerable to such crass errors.
But we are where we are, and the text is the text: I think this would need an amendment to fix it, but I hear this is now impossible without going to second reading. The process from here is quite convoluted and doesn’t welcome amendments – see the excellent explanation by Martin Callanan MEP. I simply don’t know what this will mean. I wonder if anyone does? It may be trivial. It may be serious. But it’s definitely a fiasco. Mistakes like this support the case for taking time to do a proper job, and to have proposals open to consultation, justification, impact assessment and scrutiny.
Thats why, additionnal to many other reasons, the e-cig must be removed from the TPD !!!
Another good example of unworkable text in this document. Add it to leak free filling, consistent nicotine dosage etc.
TPD – totally unreasonable!
It’s not just stupid mistakes like this that support the case for doing the job properly ! The taxpayers of Europe deserve that politicians with vested interests do not rush any new legislation. They misinterpreted the research, and have been told by the researchers that they did this, but have ignored them. And they can’t even get the procedures right, the whole thing must leave a gaping hole for manufacturers and retailers to challenge in court, and what of the poor end user who is only interested in a healthier alternative? They are left in total confusion, maybe this was the strategy ?
I can assure you manufacturers are noting all of the inconsistancies along with their lawyers becasue if this is challenged in the European court and its overturned there will be a lot of heads rolling….heads that many might like to see roll and some are biding their time to make that happen. ;)
Consider that the EU elections are coming up fast, and the average MEP will look pretty stupid appearing in a courtroom losing a battle they themselves initiated at the behest of their own government when they need to be knocking on doors looking for their seat.
I wouldn’t worry about you eliquid supplies, they won’t be stopping the critcal mass for the eliquid industry was gained last year not this year…. its too late to close the doors, the horse has already bolted.
hmm, I wonder if that leaves the door wide open in other areas though, every shred of that information can be held in a QR code which, if implemented on an eliquid bottle would not show any of the aforementioned details.
I do wonder about the removal of hazard labels though as they are already law – that would in itself create a legal loop that surely would have to give in one direction or another? This is particularly interesting as it seems Royal Mail are happy to ship eliquid providing it falls under their strength classification restrictions providing that there are no hazard or toxic warnings on the label.
Mr Bates.
If I was to tell you that you must give me £1,000, you would ask me why, wouldn’t you? If I then gave you a long list of jobs which I state that I have done at your home, would you then give the the £1,000 that I asked for? You would not, because you would know that I had not done those jobs. In fact, you would know that I had done no jobs at your home at all. If I then reduced my demand to £800, would you then pay me? You would not. You would tell me to sod off. Suppose that I then reduced my demand to £50, would you still refuse?
What I have described is the ‘de facto’ process which has occurred. It points to the obvious and only course of action for MEPs: Reject the whole directive, lock, stock and barrel.
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what about Title III?
Is it still changed from “Non tobacco Products” to “Electronic Cigarettes” implying that the herbal smokes from article 19 are “electronic”?
BTW: What a bunch of hypoc rats! Burning those “tasty” herbal things delivers smoke comparable to tobacco. So it contains all the nice carcinogens and other toxins with one exception: nicotine. Where is the complete ingredients list, emissions mesurements and blah requirements for them?
WHO knows what other toxins may develop in burning herbs?
But WHO cares about health …
No conflicting monetary interests to report that would require any further “regulation”.
They are just a bunch of charlatans and clearly not fit for purpose! They’re making it up as they go along and how can they be allowed to place a product in the TPD when it contains no tobacco? Why aren’t NRTs, containing more ingredients than ecigs, in there? As for dosing, we know NRT inhalers are inconsistent as they are affected by temperature. Blatantly ignoring consumers, purposely misrepresenting solid scientific evidence proving the safety of ecigs, ignoring invitations to meet with pro ecig experts and vapers and enforcing ridiculous and unnecessary regulations in order to sabotage superior and much more effective products is, in my book, negligence. It ensures the only one that can survive is yet another inferior, high waste producing and largely ineffective product that a huge number
of informed consumers don’t want. They are supposed to protect our health but their actions thus far prove their agenda is, as we all know, money and protecting Big T’s and Big P’s interests. To invoke the
precautionary principle using over regulation, by international and EU law, they must provide clear scientific evidence of risks to warrant it and I guarantee they don’t have it. When vapers are forced to
crowd fund to take them to court, they will waste our own tax payments against us on a known futile fight. Futile based on failed attempts by at least five European countries and the FDA to enforce unnecessary overregulation. It should not be allowed to go this far; enough taxpayers’ money is already mismanaged.
They constantly state that ecigs could be a gateway to tobacco, that they are very worried about
children taking them up, despite no evidence of either and are extremely concerned about the risks of
long term use, despite no-one dying as a result of such use in the 10 years they’ve been actively
available and voluntarily regulated for 18+ only. At the same time as shouting about these trumped up fears, they want to ultimately licence them as medicines, at an impossible cost of £millions to smaller businesses carrying in demand, innovative and diverse ranges and where child smokers from 12 years old could obtain prescriptions for them. Failing med regs, they will allow the only ones still standing as long as they can tax them to hell as tobacco products, even though they aren’t, which will mean off-putting hugely inflated prices. These two regulatory options strongly suggest that their “fears” can only be empty words with no substance, or propaganda by another name. They can’t have it both ways when they so clearly massively contradict themselves! Either way, with so many restrictions, the
vendors and vapers who’ve brought ecigs this far are facing the defacto ban, will be put out of business and we’ll be left without the superior and more efficient 2nd and 3rd generation products we really need and with a little experience, prefer, together with ineffective nicotine levels for many. Sheer outrageous bullying and amounts to being given a ten year old Escort when we desperately need a fuel efficient up to date model.
The fact that ecigs can and will save millions, even billions, of lives by cutting out tobacco use is so vitally important, it’s imperative to give proper time and consideration to their light regulation but, what do we get ……. this complete and utter, obviously rushed, shambles. Ar*e and elbow are words that spring to mind! These regulations are clearly designed to only benefit the lightest of smokers to come who won’t know there was once a much better alternative, the revenue streams of Big T, Big P, governments and anyone else whose business/university/charity depends on smoking. We know via a leak that they are protecting Pharma in “creating a level playing field”, due to their rapidly dropping NRT sales, by enforcing a ceiling of 20mg and messing about with flavours but, in the process, they are also aiding jumped on the bandwagon Big T and gifting both almost the entire ecig market to make as
boring and ineffective as they desire, or they may even phase them out A low nicotine level of 20mg/ml equates to a third of a cigarette and therefore excludes >30% of heavier smokers who need them most. They won’t successfully make the switch as, in order to replicate the nicotine from their cigarette use, many need to begin with up to 55mg/ml and then we self titrate down as we desire – discrimination I’d say; so much for looking after our health! They completely ignore the fact that nicotine is legal and not a medicine, together with the whole point and intended use of ecigs being primarily to enable smokers to continue enjoying recreational nicotine by means of a far safer alternative to smoking tobacco and we shouldn’t need anyone’s permission to do so, or for the right to protect our own health as we see fit. No vendors market ecigs as quit aids and yet legislators continually refer to them this way in order to try and enforce their ridiculous and unnecessary regulations.
The joke of it is that smokers can kipper themselves to death with absolutely no restriction or permission needed. This current intentional farce can only result, for those faced once again with no viable alternative, in a continuation of/or return to smoking, 50% of whom will die early; 50% of those <60. Premeditated murder? Collateral damage for revenue? The other result will be those in the know being forced to break the law buying from one extremely enormous, sometimes dangerous, no revenue generating black market.
“When vapers are forced to
crowd fund to take them to court, they will waste our own tax payments against us on a known futile fight.”
Not a bad idea… and one that would result in a lot of heads rolling. Wheres the project? have you iploaded one? are you thinking of doing it? Hpw much money is needed? any more info?
I am with you!!!
They are treating e cigs as they do tobacco cigarettes. Like hiding tobacco behind closed shutters. It just vexes the smokers and I wonder if that’s the purpose of hiding tobacco. Since smoking isn’t illegal, it sounds awfully a lot like spite. The same must apply to information about e cigs. What possible reason could they have for hiding flavours.
Surely it’s better to vape a higher nicotine level than to smoke. My first e cig was a cig a like, and I still smoked because it wasn’t satisfying enough.
This link goes back to 2005 and is/was supported by the government, drafted by the MHRA.. A close read shows that they supported the very things that are being suppressed in the article 18 proposal, but then e-cigs were not a threat! It even goes on to promoting /supporting use of NRT with cardiac patients, adolescents and use during pregnancy. (thus widening the customer base for pharma’) Clearly a contradiction! http://www.mhra.gov.uk/home/groups/pl-a/documents/websiteresources/con2023239.pdf
I should have added, the 2005 version looks more like an argument that we’d put forward for THR.
It’s also on public record that the MHRA’s Working Group on NCPs in justifying the Govt’s EU TPD stance on medical regulation of NCPs concluded that any nicotine triggers would be detrimental to public health – the primary focus of having e-cigs within the TPD. In other words their scientific conclusion was e-cigs had to be either 100% medical products or 100% consumer products as anything else would create consumer confusion and nicotine level triggers would increase this confusion which would not be to the advantage of public health.
Logically, its totally correct as taking the current TPD proposals how can half an aspirin be classified as being any different to a full aspirin tablet? So a 19mg/ml e-cig isn’t a medicine, but a 21 mg/ml e-cig is. Crazy ill thought out and totally illogical.