For the Record: ECITA’s Breakdown of the TPD Proposals on Electronic Cigarettes

Let’s examine this ‘final text’ of the TPD which came out of COREPER on 17th December 2013; what do we have?

Art 18 1

‘Nicotine containing products’ has now been replaced by Electronic Cigarettes, which is an improvement and a problem all at the same time. (There are many conflicts and contradictions in this ‘final text’, so buckle up for the ride….)

OK, so it’s great that Electronic Cigarettes have finally been recognised as the real issue here, but in doing that, hasn’t it now become obvious that a separate regulatory instrument is required? As in, a properly researched legislative proposal to examine what would be the best way to regulate electronic cigarettes specifically? Perhaps a bespoke framework, such as was done with the Cosmetics Directive?

Unfortunately, the downside to this recognition is that it leaves a rather dangerous loophole, if we assume that the EU doesn’t recognise its own Directives which already apply to ecigs and nicotine containing products (and every other product which is now or may ever be on the market!): it leaves nicotine containing products which are not ecigs, or medicinal or tobacco products, outside of the regulation. And they do exist.

The upside is that now non-nicotine containing electronic cigarette products would be covered. But covered in what? (Covered in…. Feel free to add your own ideas! ;) )

Art 18 2

Since this Directive conflicts with a lot of “other relevant Union legislation” as well as various international treaty obligations, it is hard to imagine how this made it into the final text.

Of course it does appear – at first blush – to confirm that electronic cigarettes do not have to be reclassified as medicinal products, but since many Member States are in the habit of ‘gold-plating’ EU Directives, and they do have the ability to add extra requirements if they choose to, this is cold comfort. (Fortunately, the Courts have been looking at the real evidence, so no doubt, unwarranted medicalisation of these consumer products will continue to be successfully headed off.)

Art 18 3.JPG

This seems to be some sort of strange hybrid between a Marketing Authorisation for a medicinal product and the notification requirements for tobacco products – plus a bit! Don’t believe me? Check out the detail!

Art 18 4.JPG

Well, (a) above is already largely covered by various existing Directives, but (b) is a step too far. Ingredients? Yes, obviously. That makes sense and is already required, but emissions? These are not tobacco products. We would support emissions testing, but only once enough research has been conducted to be able to form a meaningful standard for such testing. In the absence of a meaningful standard, emissions data is largely irrelevant. There is already sufficient data about the contents of the vapour produced by electronic cigarettes to know that there is a practically negligible risk associated with them. So where is the proportionate justification for demanding such a burdensome, and unclear requirement?

Art 18 5.JPG

(c) sounds like tobacco regulations, but these are not tobacco products.

(d) sounds like medicinal regulations, since it is medicines which have doses, and these are not medicinal products. (How many courts have to rule on this before they will listen?? We are up to 7 rulings now, with the recent one from Hungary. It beggars belief!)

(e) this would be the “refill mechanism” which the Commission hasn’t invented yet. No. Just no.

(f) err… already required by various Directives for compliance with them, and since the “requirements in this article” either don’t apply, are illegal, or are just plain daft, again, no. Just no.

Art 18 6.JPG

Again, this is already enshrined in the legal obligations of manufacturers, together with very clear definitions of who is considered a ‘manufacturer’ (and ‘importer’, ‘distributor’, or any other kind of ‘economic operator’), so it seems a bit pointless to ask for a declaration of what is already a legal obligation under at least 4 other Directives, specifically concerned with product quality and safety. Indeed, a specific Declaration of Conformity is required under the RoHS Directive anyway.

This is yet another indication of the EU Institutions’ total ignorance of the existing regulations – which is all the more shocking, because we have personally introduced them to their own Directives on more than one occasion, to more than one Institution, over several years now!

“Proportionate fees” wouldn’t be a problem, but if only we could have proportionate proposals!

Art 18 8.JPG

Tut tut! Flagrant disregard for international, binding obligations on environmental protection, such as:

“The overarching objective of the Basel Convention is to protect human health and the environment against the adverse effects of hazardous wastes. Its scope of application covers a wide range of wastes defined as “hazardous wastes” based on their origin and/or composition and their characteristics (article 1 and annexes I, III, VIII and IX), as well as two types of wastes defined as “other wastes” (household waste and incinerator ash; article 1 and annex II). The provisions of the Convention center around the following principal aims: (i) the reduction of hazardous waste generation and promotion of environmentally sound management of hazardous wastes, wherever the place of disposal…”

And

“The Bali Declaration on Waste Management for Human Health and Livelihood, adopted by COP 9 in 2008, has affirmed at the political level that waste, if not managed in a safe and environmentally sound manner, may have serious consequences for the environment, human health and sustainable livelihood.”

How can the EU suggest that it would rather see disposable products than the infinitely more environmentally-friendly refillable and rechargeable ones? And obviously, the bigger the tank (or cartridge), the bigger the reduction in waste products. Surely that one is a no-brainer – particularly in the context of the total absence of evidence of harm caused to anyone over the past 8 years by ecig cartridges or tanks.

Art 18 39

Obviously, this cannot be an acceptable level, if this is truly about helping smokers make the switch away from tobacco smoking. This is also an egregious and apparently deliberate misinterpretation of the fine work of Drs Farsalinos and Dawkins, and others.

Art 18 40

And in paragraph 4 of Article 6, for tobacco products it says:

Art 18 11.JPGPossibly makes sense for tobacco products, and obviously, we wouldn’t want to see vitamins (or god forbid, Viagra – which doesn’t even vapourise! Doh!) included in eliquid, but since no-one is producing such a product, is this really necessary? As for caffeine, where’s the problem? There are caffeinated eliquids out there, and if people want to vape their caffeine as well as drinking it, then why the hell not? Again, where is the evidence that caffeinated liquids cause health problems? It doesn’t exist.

(c) sounds like a purely tobacco measure, relating to additives for making the smoke look less deadly (perhaps), but certainly doesn’t apply to ecigs. No one is producing eliquid with green vapour. (And yes, that does sound rather appealing, doesn’t it?) Since it’s not smoke, where would the problem be with that? Seriously, though, we would not tolerate such additives under our standard for eliquid manufacturing anyway.

(d) is the anti-menthol cigarettes bit, and is really not appropriate for ecigs, particularly when what is actually needed is improvements in nicotine uptake from ecigs (although we’re not doing too badly for that with the better devices).

(e) Well, everything ecig is “unburnt”, and of course we don’t want to see “additives that are carcinogenic, mutagenic or toxic to reproduction”, but there is plenty of protection against such things in the existing consumer regulations.

This just goes to show why it is daft to try to apply tobacco regulations to non-tobacco products.

OK, so back to Article 18, para 3:

Art 18 12.JPGYes, obviously, and already part of the existing requirements.

Art 18 13.JPGAgain, yes, obviously, and already part of the existing requirements.

Art 18 41

No, because ecigs aren’t medicines. (And yes, I’m as sick of saying it as you are of hearing it!)

Art 18 42

Child-proof already required by CLP, and tamper-evident eliquid bottles is good practice. (‘Tamperproof’ would mean ‘unopenable’, so presumably they mean tamper evident.) However, if tamper evident ‘refill containers’ is to include hardware, such as the tanks on refillables, then this would be hugely problematic, resulting in no rebuildables, no changeable atomising heads, etc.

Art 18 16.JPGShades of Professor Branestawm here. I can’t wait to see what the Commission invents for this. Trouble is, it won’t be an ecig is we know and love them, so no. (Also, as Tom pointed out, since eliquid bottles have to be child-proof, and children aren’t supposed to have these products, children shouldn’t be refilling them, so why would they need “leakage free refilling”? ;) )

Art 18 17.JPGThis is a blend of medicinal, tobacco and consumer regulations. Ends up being a predictable and unnecessary mess. The existing requirements are more than sufficient to protect consumers. (And with a nod to the irony, considering the length of this post, who wants to have to have War and Peace accompanying their ecig?? I mean, there’s quite a bit of information that’s already required under the existing regs. Add this lot and it’ll be a weighty tome!)

Art 18 18.JPGIngredients, nicotine content, and batch number already required. ‘Keep out of reach of children’ has been replaced with ‘Store locked up’ for nicotine products by the CLP Directive, which applies an internationally-binding new system for Globally Harmonized System labelling, which the EU has signed up to. It is interesting to note that ‘keep out of the reach…’ is hazard class 3, whilst ‘store locked up’ is hazard class 4. 4 is more hazardous than 3, so the GHS has strengthened CHIP (which was replaced by CLP under the GHS). No doubt, once the toxicity of nicotine is properly recognised as being far lower than currently assumed, this will change back to hazard class 3, and ‘keep out of the reach of children’ can be properly reintroduced. “Delivery per dose” is a medicinal concept, and doesn’t apply to non-medicinal ecigs.

Art 18 19.JPGArticle 12, paragraph 1(a) is a fairly bizarre proposition, considering it’s in the tobacco products bit:

Art 18 20.JPGTotally and utterly irrelevant to ecigs, which categorically do not promote or encourage smoking – precisely the opposite! And bear in mind that this is increasingly well-supported in the academic literature.

Also, in Article 12, paragraph 1(c), it reads:

Capture 1Capture 2

So, in direct contravention to the regulations surrounding Misleading Marketing and product descriptions, we would no longer be allowed to describe the flavour of the products! Ridiculous!

Article 18 goes on:

Art 18 21.JPGIt’s bad enough that we can’t tell the full truth about the products now, but the notion of putting these misleading warnings on ecigs is anathema. Talk about contrary to the “high level of public health” obligation!

Art 18 22.JPGAnd paragraph 2 of Article 11 (for tobacco products) refers to Article 8(4):

Art 18 23.JPGwhich sets out the requirements for those distinctive tobacco warnings:

Art 18 24.JPGSurely, it would be dangerously misleading for consumers to see tobacco-style health warnings on a safer, non-tobacco product??? What can the EU be thinking?

And back we go to Article 18, paragraph 5 (they do like to send you all over the document, don’t they?):

Art 18 25.JPGOh dear, oh dear. So that’s no VTTV, no RY4 Radio, no forums which allow vendors to post (so that includes all of them) – but fortunately, this is a totally illegal infringement of Treaty obligations under the TFEU (amongst other reasons), so cannot survive to the end game.

Art 18 26.JPGNo.

Art 18 27.JPGSo no multi-state Vapemeets then. Like that could be stopped! They’re deluded if they think this can work!

Art 18 28.JPGFortunately, the ASA is working on sensible, sector-specific guidance, so this should be easy enough to overcome.

Art 18 29.JPGAnd yup, you guessed it: Article 16 describes the ban on cross-border sales of tobacco products. They can just about get away with this contravention of the Treaty obligations, because of the WHO FCTC, but that’s for tobacco products, not ecigs. Not a chance!

Art 18 30.JPGCan you think of a single other consumer product for which manufacturers are expected to undertake such a burdensome procedure, in addition to the legal compliance they already have to achieve? No, neither can I.

Art 18 31.JPGThat’ll be like watching paint dry then, but fair enough. No doubt no news will go on being good news in that respect.

Art 18 32.JPG… as they are obliged to do, yes.

Art 18 33.JPG

“Adverse effects” is a medicinal concept. Consumer products are either ‘safe under reasonably foreseeable conditions of use’, or they are not, and if they are not, they are graded by how dangerous they are. This is a good system. It works. There’s even a well-coordinated EU-wide system for reporting dangerous consumer products: RAPEX.

So let’s just put this hysterical fear of possible (and as yet, undocumented) “risk to health and safety” in context, shall we? For the whole of 2013, there were 6 RAPEX alerts recorded under the search term “electronic cigarette”, and 1 further one recorded under the search term “e-cigarette”, all of which were either for non-compliance with the Low Voltage Directive, or non-compliance with CHIP/CLP for labelling. (In other words, if those vendors had been compliant with the existing regulations, there wouldn’t have been a problem.)

By contrast, for the whole of 2013, there were 482 RAPEX alerts recorded under the search term “toy”, of which 457 were “serious” (the same level as for all 7 of the RAPEX alerts for electronic cigarette products recorded for that year).

Art 18 34.JPGThey do seem to want to watch a lot of paint drying, don’t they? And since almost all the currently available products would no longer be available under this proposal, what can they learn?Art 18 35.JPGOK, this one actually sounds scarier than it is, to a certain extent, because they DO have to have “reasonable grounds for concern”, and the “competent authority” may take “appropriate measures”… which is kind of what happens with RAPEX already.

They seem to be increasingly desperate for some evidence of harm, don’t they? We just need to make sure we don’t give it to them.

Art 18 36.JPGAgain, “justified grounds” and their action has to be “justified and proportionate”.

I realise it’s cold comfort, when this TPD revision was supposed to be “justified and proportionate”, but demonstrably isn’t. Nevertheless, it ain’t over til the fat lady sings… and I ain’t singin’ yet! ;)

Art 18 37.JPGROFL. Would be amazing if it became factual, wouldn’t it?

Art 18 38.JPGWho knew that the future ecig innovations would be coming from… the Commission? I really can’t wait to see it.

Phew! Long, isn’t it? Twice as long as the original proposal… and a bit late in the day – within this Directive at least – to be introducing completely new ideas, still with no proper consultation, impact or risk assessment, scrutiny, justification or due process.

It’s shameful.

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2 Responses to For the Record: ECITA’s Breakdown of the TPD Proposals on Electronic Cigarettes

  1. Pingback: BREAKING: EU Parliament approves TPD by lopsided margin (514-66)

  2. ian wallace says:

    does this mean doctors can not promote ecigs to their clients or say about the health benefits as its all promotion and they get fees for new items. :)

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