January 27th, 2014

Updated: Questions that must be answered: Tobacco Products Directive

chrisdavies

After the dismal ENVI committee meeting last week, some better news.  Chris Davies MEP wrote to the Commission asking them to explain how the directive is supposed to work and arguing that there is:  “a strong argument for the Commission to return to this subject in the near future, propose new legislation that takes account of all available information and recasts Article 18, removing electronic cigarettes from the scope of the Tobacco Products Directive.”  Well, yes there is.

What exactly is the argument against doing what Davies argues? I guess we will find out when Commissioner Borg replies.

Update 6 February 2014: Commissioner Borg provides clarifications in a meeting (see Chris Davies’ note of the meeting). 

___________________  TEXT OF LETTER _________________

23 January 2014

Commissioner Tonio Borg
European Commission

Dear Commissioner

Electronic cigarettes – Article 18 of the Tobacco Products Directive

Remarkable progress was made during the course of the trilogue negotiations to fashion workable legislation that can address health and safety concerns while ensuring that electronic cigarettes remain widely available as an alternative for smokers.

Nonetheless, both e-cig users and e-cig manufacturers have concerns about details of the legislation. Before MEPs vote on the proposed legislation in plenary it would be helpful if you could address these by way of clarification, or at least provide an indication of the way in which the Commission will seek to prepare guidance.

Let me highlight the matters that have been raised with me. In some cases my impression is that the text already provides the reassurance that may be sought but your personal confirmation should help settle matters.

Recital 32a of the TPD says that Member States may regulate electronic cigarettes as medicines “by function”. Does this not undermine the objective of securing a harmonised approach across the EU? (I accept that Member States have the right to regulate products as medicines if they can demonstrate that that is what they are).

The requirements that data on toxicology and nicotine dosing be provided surely means that electronic cigarettes will be required to undergo a medicine-like evaluation? Does this place them, in effect, in a similar category to pharmaceuticals requiring very expensive testing procedures? How can it be ensured that such a requirement does not result in great costs, especially for SMEs? So far as I am aware there is no standard test for emissions from e-cigs so these provisions create huge uncertainty. What guidance will the Commission provide, and by when? E-cig manufacturers are, of course, very aware that tobacco cigarette manufacturers are not required to provide any such information and question the apparent dual standards.

Member States can ban flavours, yet the principle of mutual recognition presumably continues to apply. How do you envisage this apparent conflict being resolved in practice? Will flavours available in one EU country continue in practice be available in the others?

Article 18.4(b)ii suggests that packaging for e-cigs cannot refer to the flavouring of the product. But this is information that is essential to consumers. How will the Commission explain to Member States how this provision should be interpreted?

Will you confirm that the Commission’s interpretation of the provision that delegated acts may be introduced to ban refillable containers if three or more Member States have done so refers to specific types of containers and not to the entire category?

While refillable containers may be made child-proof, how do you make a disposable electronic cigarette child-proof as is required? What guidance will the Commission issue as to how this obligation is to be met, and by when?

E-cigs must deliver the nicotine dose consistently, and it must be indicated on packaging what is the delivery per dose. However, the nicotine dose varies with the user and the degree to which they suck. How will the Commission advise Member States to interpret this requirement? Why did the Commission not introduce a requirement into the TPD that tobacco cigarette manufacturers should also provide this information?

In drawing up guidelines and clarifications will you confirm that the Commission will do its best to consult with the e-cig manufacturers and assist them to comply with the legislative requirements at lowest possible cost?

I cannot conclude without emphasising again the sense to which e-cig manufacturers and users feel the victim of dual standards. Requirements that place burdens upon these products that are not so placed upon tobacco cigarettes make little sense given the widespread acceptance that the use of e-cigs is likely to be a significantly less dangerous practice than smoking. E-cigs may save many lives, and restrictions may reduce their ability to do so.

Great progress has been made but it was also achieved in very much less than ideal circumstances, and through negotiation and bargaining with little reference to objective appraisal or scientific evidence. You will be aware that scientists are complaining that evidence about the nicotine content of tobacco cigarettes has not been taken into proper account.

There must be a strong argument for the Commission to return to this subject in the near future, propose new legislation that takes account of all available information and recasts Article 18, removing electronic cigarettes from the scope of the Tobacco Products Directive.

What is your personal opinion of this proposal? Will you recommend that the Commission gives the idea urgent consideration?

With regards.

Yours sincerely

 

Chris Davies MEP

Response from Commissioner Borg

Update 6 February 2014.  Chris Davies has met the Commissioner and reports back on his meeting, with some assurances from Mr Borg.  This is the email from Davies describing what he was told by the Commissioner.

Date: 5 February 2014 16:26
Subject: Meeting with Commissioner Borg

Dear ColleagueI met yesterday with Commissioner Tonio Borg to discuss Article 18 (Electronic Cigarettes) of the Tobacco Products Directive and questions of detail over its interpretation.  He was able to provide me with some of the assurances I had sought.

The Commissioner stated that according to the current wording of the Directive any Member State that wants to control e-cigs through pharmaceutical legislation would have to justify this.  The Commission would insist that the proper procedures were followed and would have to be satisfied that there was no attempt being made to introduce a ban by other means or to create an obstacle to trade.

He made clear that the Commission would only propose a product-specific ban on certain types of refillables if there was clear evidence of a safety risk.  This would be by way of a delegated act and could be challenged by the Parliament if inappropriate.

He explained that the requirement that consistent nicotine doses be delivered meant under identical conditions, and he confirmed his understanding that actual nicotine delivery would depend upon how hard a user sucked on the e-cig.

The Commissioner admitted that there are currently no standards or regulations to guide the toxicology requirements but gave a strong indication that the Commission would not expect manufacturers to provide toxicological information of anything approaching the kind needed for pharmaceutical evaluation.  Guidelines might be prepared after consultation with e-cig manufacturers.  If individual Member States prepared stricter measures they would have to be justified to the Commission.

He suggested that concluding the Tobacco Products Directive by the end of the mandate (April) was surely a matter of credibility for both the Council and the Parliament.  I discussed with him what might happen should the Parliament insist that Article 18 be removed from the Directive.  He stated his belief that the Council would not accept this and would block the deal.  Given the time restraints that now exist this would mean that the proposal would have to go to 2nd reading, and thus be considered later in the year and into next by the new Parliament with a very different composition.  The eventual outcome would be uncertain.

I raised with him the concern of scientists that their findings on nicotine strength had been misinterpreted.  He reminded me that the Commission had proposed a maximum of 4mg and that the Council had argued for 2mg.  He said that in the event that e-cigs were not regulated by EU law we should expect many governments to introduce greater restrictions than were now being proposed.

The 20mg limit agreed with the Parliament would encompass 70% of the e-cigs now being sold in the EU.  If manufacturers wished to make e-cigs available with a much higher nicotine content for the benefit of heavy cigarette smokers they could seek to have these products classified under pharmaceutical legislation.

He did not rule out the possibility of the Commission introducing in future a recast of the legislation specifically to apply to e-cigs, but he suggested that our understanding of the way in which e-cigs were being used would have to be much improved before this would be considered.  In any case, it would be a matter for a new Commissioner, so who knows?

I explained to him that there was a particular problem with the proposed restrictions on information about flavours.  I said consumers had to be able to distinguish between an e-cig flavoured with, say, honey as distinct from one flavoured with vinegar.  He took on board the fact that there was an issue here that would have to be resolved.

The Commissioner said that he had a lawyer linguist technical meeting arranged for February 10 and thereafter he would respond in writing to this and my other questions on points of detail.

With regards

Chris Davies MEP

 

 Update 25 April 2014: Borg’s letter back to Davies of 25 February 2014.

Screen Shot 2014-04-25 at 16.18.40

25 comments to Updated: Questions that must be answered: Tobacco Products Directive

  • This is positive, of course. But I’m wondering if Borg’s obliged to answer this letter and if a confirmation will be binding?

  • I appreciate Chris Davies’s letter however I’m mindful of the fact that he is in affect asking for a personal opinion on what is the contents and implications of a long and complex legal document. Has he never heard of the phrase “caveat emptor”? It does not matter what Borg personally believes, as in every likelihood he’ll be enjoying the fruits of his EU pension in a few years time, whilst the TPD continues, so the priority is what are the legal impacts of this legislation. In other words what can or can’t be enforced under this legislation. Mr. Borg’s personal opinion is frankly irrelevant. As MEPs are themselves beginning to realise when they try to abolish the merry go round of the Strasbourg monthly parliamentary sessions, as this is also enshrined in EU legislation i.e. The Lisbon Treaty which as a legal document is taking precedence over even the democratic wishes of its MEPs.

    • LVD

      I’ve written to Rebecca Taylor about the danger of those legal implications a couple of days ago and I’m under the impression she’s listening.

    • Rita Cheliotis

      Fully agree with you-wrong approach. The personal opinion of Mr.Borg is of no interest or value. The whole concept and administration of this TPD is!-no personal opinions asked!

  • Dodderer

    A good letter – I think Borg is obliged to reply – legitimate enquirer with legitimate enquiries.No reply would show weakness as would a weasly reply.

    Unless the Commission is full of dishonest people acting dishonestly, of course.

  • […] After the dismal ENVI committee meeting last week, some better news. Chris Davies MEPwrote to the Commission asking them to explain how the directive is supposed to work and arguing that there is: ”a strong argument for the Commission to return to this subject in the near future, propose new legislation that takes account of all available information and recasts Article 18, removing electronic cigarettes from the scope of the Tobacco Products Directive.” Well, yes there is.  […]

  • Dragonmum

    I think Chris has done the best he can with the means available to him, though I would have liked some reference to nicotine strength and container capacity, 20mg in 10ml bottles is farcical as we all know – this is my personal sticking point. Bearing in mind that this decision by the Commissioners was arrived at behind closed doors, and more or less overturned a document which was agreed by the parliament in October, I really don’t think he’s going to get much of a response. Users of a product are the biggest stake-holders in the fate of that product – we, the users, have had no say in this at all. Despite the fact that there are millions of vapers EU/UK wide, most with a relevant association, not one attempt has been made to elicit our opinion, let alone to enter into any kind of dialogue. Given that this would have been the logical and intelligent approach, and that such huge Public Health benefits hinge on the outcome, one can be forgiven for assuming that there are some very dark forces at work here which override any concern for the well-being of the citizens of the member States.

    • Michael Barton

      I think the reference to the scientists complaints effectively brings up the 20mg question. I agree completely with everything else you say.

  • […] After the dismal ENVI committee meeting last week, some better news. Chris Davies MEP wrote to the Commission asking them to explain how the directive is supposed to work and arguing that there is…  […]

  • Michael Barton

    It is good to see Chris Davies taking up the requests of the electorate once more. Albeit not as strongly as before. I can only assume after his claims of a great victory he has come to realise the victory is as shallow as certain labour Mep’s conscience.

    Like those above I do not believe Borg’s opinions are of any worth in a legal sense. However it is a response required that ‘may’ shake a few rats out from under the shadowy confines and corners of the EU.

    If Borg gives a non committal answer it will be more evidence for our side that there is something rotten in Brussels. If on the other hand he agrees more investigation is required it strengthens the call to remove article 18 until more study is done.

    Either would be a set back for big p and big t interests.

  • Junican

    There are very, very serious problems in the whole ‘rationale’ of the EU which are only now becoming apparent, and it is thanks to the Tobacco Product Directive, especially Article 18, that we are becoming more and more aware and that the problems are becoming gradually more visible.
    The specific problems of which I speak are:

    1. “The level playing field”
    It is obvious from the phrase that ‘the level playing field’ stultifies competition.
    2. “EU Law”
    There is no such thing. “Law” is that which individual States enact.
    3. “The Euro”
    A failed and failing concept because unequal and variable individual State economies have no way to adjust the relative values of assets. But the Euro would have been a wonderful idea as a commonly accepted alternate currency which could be used throughout the Common Market; that is (GOD FORBID!) shop tills and shop staff in the UK would have to gain the mental expertise to press the right button on the till if they were presented with Euros rather than pounds.
    4. The concept of ‘Health’ as a measure of human worth is a lie. That lie is just as wicked as eugenics.

    I am sure that there are more ‘points’, but that will do for now. You might ask, if you are a rational human being, how ecig ever got into this magnitude of inspection. You would think that each ecig is an atomic bomb, and that the ecig ‘industry’ is an atomic power station.

    ====

    I see that the MHRA has back-pedalled. Has Clive seen this:

    http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice%E2%80%93M%E2%80%93T/Nicotinecontainingproducts/index.htm

    The only important sentence is the first – the rest is regurgitated dogma. Here is the first sentence:

    The UK will reflect the outcome of continuing negotiations of the European Tobacco Directive (external link) which aims to bring in additional regulatory requirements for electronic cigarettes that are not licensed as medicines.

    Voila! “Will reflect”!!! Meaningless mumbo-jumbo as usual, but clearly diminishing the original claim that the MHRA is autocratically authorised decide. Personally, I do not believe that membership of the MUFC fan club automatically entitles such members to ‘mental disability benefit’, but that would make more sense than to ‘exile vapers to the outdoors’ (as well as tax them to such an extent, by law, that they are not permitted to become ‘self-sufficent’. [I doubt that Clive and others are aware that the Charlatans and Zealots of the Tobacco Control Industry sneaked an amendment through a Finance Act which, in effect, denied every individual citizen of this country the right to be self-sufficient. That is, the Zealots played a trick and got an amendment passed to the Finance Act which stopped people who grow ‘nicotine products’ in their own gardens from enjoying the fruits of their labour.

    That is what “Fear of the Night” has accomplished, and, sadly, with the best of intentions, that is what Mr Bates, unaware of the “unintended consequences”, engineered in his time at ASH.

    I wish you vapers well. Personally, as a 70 odd year old little old man, after smoking tobacco cigs since I was nineteen, I am a little less than dead (if you believe the Doctors Study). I am one of millions of ‘undead’. I don’t expect for a minute that I’ll peg out in the immediate future, and so my ‘undead’ powers will grow and grow.

    But, Vapers, do not expect me to join you when you use your position as holders of ‘the high moral ground’ to gain your way. But I SHALL DO SO, out of a sense of humanity. As a disgusting, filthy, stinking smoker, I do not expect reciprocal respect.
    But, Vapers, do not forget your cousins who just want to be left in peace to enjoy ‘pure’ tobacco, and not be taxed out of existence. The cruelty of The Tobacco Control Industry is only just being aimed at you. The BLITZKRIEG has yet to begin.

  • Comments requested…..well the use of such words and phrases such as “if appropriate” or “would need to justify this” or “my understanding” or “strong indication would not expect” and to cap it all “would expect the correct procedures to be followed” no doubt in the same manner that this TPD has followed the correct procedures doesn’t actually reassure me Can’t say I either believe or actually trust his assurances as at some point in the future what will actually matter isn’t any assurances, but what is legally permissible within the TPD. Not sure his assurances will bear any weight then.

    Hopefully Schultz will agree to the split and vote option, although I’m not holding my breath. I suspect that all the politicians are just hoping that we will go away.

  • Jeroen Dehaene

    I don’t really understand what to make of this but one thing is certain: the commission is very annoyed by the noise we (and especially you) make and is unhappy with the result of the ENVI vote. It looks like the ban on flavour descriptions is out and possibly 2nd and 3rd gen vapourisers will be allowed, as wel as the bigger tanks, but still a maximumum nicotine content of 20 mg and maximum bottle size of 10 ml. I would still much rather have Schulz agree to the split and vote. Time is definitely on our side, by the time there will be a second reading, there will probably be much more research available. Dr. Chris Bullen, the author of the Lancet paper that was widely misused to cast doubts on the efficacity of ecigs as a cessation tool has himself stated on Twitter that trials with 2nd gen devices are desperately needed, and besides, with the money that Big Tobacco is throwing at the ecig market currently, I have no doubt that there are a lot of McKeens and Glenzes out there telling the world how wonderful and harmless ecigs are.

  • Anonymous

    We all know that the vapor production is mainly determined by the coil. So I fear that the “constant delivery” will be interpreted as any device that has a changeable coil will not comply. Another sleazy trick to ban all 2nd and 3rd gen devices in order put the crap of big T into a monopoly position.

  • It is good to know what the intentions of the EC are, but in case the wording of the TPD remains as vague as it is now, a member state can easily say that it justifies medicinal regulation based on the current local laws (take a look at what is going on in Italy or Hungary for example), and in this case getting a response from the EC to invalidate the claims of a member state might take a lot of time. A government might always stomp first and cripple vaping locally for years before the issue can be resolved.

  • george le coat

    the proposal would have to go to 2nd reading,.. .. The eventual outcome would be uncertain.

    Obviously a poor proposal if it is unlikely to be confirmed on a second reading.

  • Interesting.
    However since I do not trust what comes out of Borg’s mouth I have very strong reservations. The wording used, if close to what Borg actually said, is full of politician speak. In other words there are no definitives, only generalities designed to sound positive but also being open to a wide range of interpretations.
    “He stated his belief that the Council would not accept this and would block the deal.” this is the obvious statement designed to scare MEP’s into voting it through as is. Doesn’t matter that article 18 is unfit for purpose and illegal they just want to cram their square block through a round hole.
    “He explained that the requirement that consistent nicotine doses be delivered meant under identical conditions, and he confirmed his understanding that actual nicotine delivery would depend upon how hard a user sucked on the e-cig.” thanks but I would prefer they did not have a regulation that was open to a personal interpretation by a bureaucrat or lawyer since no two would probably interpret it the same way.
    “He reminded me that the Commission had proposed a maximum of 4mg and that the Council had argued for 2mg.” so what ? We know they just plucked numbers out of the air either through misunderstanding the technology, by prompting from pharma misinformation, or by misinterpreting science. The fact they moved from initial position means nothing since they are still choosing to ignore scientific data that does not meet their personal perspective.
    “The 20mg limit agreed with the Parliament would encompass 70% of the e-cigs now being sold in the EU.” So they have made assumptions about the market and don’t care that they are wrong, anybody not fitting their neat profile can just smoke or die – since the chances of higher dosed product getting market authorisation is likely impossible.
    “he suggested that our understanding of the way in which e-cigs were being used would have to be much improved before this would be considered” this bit, to me, means to have separate tailored regulations we would need to convince them we were using e cigs differently to how they perceive we use them – we know already they have a basic lack of understanding so this would be almost impossible.

    I await the response after the linguistic meeting but I assume it will still be filled with political double talk that will not give any assurances, just wide open meaning.

  • LVD

    Personally when I started with the e-cig I NEEDED 36mg to satisfy the effects of addiction (not available in France but I got it elsewhere). I slowly felt I could diminish this and now I use 5mg; no longer because I need it, but because I LIKE it better then the 0mg. A bit similar as with coffee and decaffeinated.

    So to MHO the 70% who are served by art.18 are mainly long time vapers, not the ones who are just starting. Just another attempt as there are so many in art. 18 to discourage newcomers and to stop the e-cig.

    The 2ml limit is there to ban all 3th and most 2nd generation devices. Remember the original proposal of the commission to ban all refillables, and that leaked proposal clearly discloses the true intentions of the commission who wrote it out of the blue, or are we supposed to have already forgotten.

    The ‘constant delivery’ clause bans all 3th generation devices; a variable voltage or wattage device is variable and thus not constant by nature. And that is exactly the reason why they work so much better than the 1st generation devices that deliver a more or less constant pharmaceutical dose, exactly as do NRT. The 1st gen e-cig was invented by a Chinese pharmacist remember, the 2nd and 3th gen were invented by real vapers/ex-smokers and then copied and cloned in mass production by Chinese manufacturers. And is was only after the 2nd gen became commonly available the e-cig use boomed, to no-ones surprise.

    The statement in the TPD that if the e-cig market surpasses 2.5% of the tobacco market (I assume this has to be read if the e-cig eats into the tax income by more then 2.5% on a EU-level) the commission will have the power in delegated act to tighten regulation (Yes indeed the commission wrote it clearly as “TO THIGHTEN” not as “to change” or “to review”). This sums it up nicely. It all points in the same direction: blocking all innovation, all progress, all growth,… reducing and restricting the effectiveness of e-cigs to that of NRT, as much as possible. And after the trilogue trying to sweet talk the existing users (and ALDE) hoping this will silence us (and ALDE).

    But my conscience is clear (as is the one of Clive and so many others), I did what I could. It is Tonio Borg who will go into history as the one who tried to kill millions of EU citizens for money. And I’m still wondering what ALDE will do in this.

    • I had to just comment on your great post. Succinctly put and the very reason why in the main the e-cig users have just been ignored and excluded within the whole political process. We know what works and why e-cigs work so they weren’t going to ask us our opinion, when the TPD with regard to e-cigs has only ever had one objective and that has been to curb or severely restrict e-cigarettes.

      • LVD

        ALDE is the problem nowadays. Frederique apparently has been silenced since we no longer hear from her. The chair of ALDE Guy Verhofstadt is a candidate for the presidency of the EU-commission. So he does not want to be depictured as the one who torpedoed the TPD. However in his electoral speeches he always stresses out he want a Europe that tackles real EU-problems like international banking, climate change, the euro-currency,… problems that can not be solved on the level of the member states, and he wants a Europe that stops to make the most absurd regulations about the vacuum cleaners we use, the water in toilet flushes, the olive oil in restaurants,… In that list of stupid and obnoxious regulations one could add the e-cig. It would give Mr. Verhofstadt a bit more credibility if he would actually do something about it in his current position as the chairperson of ALDE instead of only talking about it in electoral speeches how he whishes to stop absurd EU-regulation.

  • Rob

    “Guidelines might be prepared after consultation with e-cig manufacturers.”
    Well this tells me that there may be more chances for manufacturers like BAT to all be cozy in a little room sliding a briefcase under the table…

    In reality, I would expect the “core” e-liquid makers would be left out in the cold…

    Thanks Clive, for all you do!

  • Dragonmum

    When a Commissioner “Gives a strong indication”, “States his belief” or “Takes on board” it means absolutely nothing. This is just one big stitch-up to fit in with the requirements of the multi-nationals. I see this ending in a big legal action, and we’d all better be ready for it.

  • Chris Price

    I suggest you replace the name ‘Borg’ with ‘Dalli’ and see where it takes you…

    Dalli’s reply would have been precisely the same, and equally meaningless.

    They are paid to kill ecigs and that’s what they’ll do until found out and sacked. Unfortunately the current lot will be a lot more careful than Dalli; he succumbed to the usual megalomia of ultimate power and believed himself invincible.

    The entire mechanism of the EU is murderously corrupt, and you’d have to be barking mad to believe this has anything at all to do with health. Why is anyone taking any of this seriously? That seems the only valid question here.

  • Els

    Hi Clive,

    I am looking for the written response that Chris announced at the end of his e-mail/meeting note. Do you know if it was given, and if so, was it published and where?

    Some Member States (politicians) say they want to implement an overall medicines regulation for e-cigs based on the fact that “it is still possible to regulate them as medicines”, neglecting all the hurdles that in fact make it impossible to legally classify all ecigs as medicines. (They are not taking the dual route that MHRA announced.) Legislation like that won’t stick in the end I’m sure, but is best not drafted at all.

    Hope you see my comment/question and appreciate an answer.

    Regards,
    Els

  • Clive Bates

    I’ve added above a copy of Borg’s letter I dug out from email exchanges….

    The Commission recently circulated a questionnaire in which they asked if member states were going to regulate e-cigs under TPD, medicines or both – clearly implying that medicines only is an option. However, this does not change at all whether it is legal to do this (and the member state courts have so far found it isn’t). The question is whether a medicines regulator can assert jurisdiction over an e-cig and apply the law deriving from medicines directive 2001/83/EC. This question is nothing to do with the TPD and the legal arguments and case law are unchanged by the TPD. In other words the Commission is saying they can carry on as some of them were – using medicine regulation to create a wholly ineffectual ban. But this is absurd in a single market measure – they are supposed to harmonise regulation.

    i hope that’s all clear… let me know if any other questions.

    Clive

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