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
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?
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 BorgDear 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.
Chris Davies MEP
Update 25 April 2014: Borg’s letter back to Davies of 25 February 2014.