David Cameron has announced his intention to control the use of e-cigs in Britain by regulating them as medicines, potentially imposing a host of restrictions on their strength and availability. His decision may now be overtaken by the introduction of new EU rules that move the goalposts, defines e-cigs as consumer products, and create an alternative regulatory approach. The UK might now risk a legal challenge if it tried to impose its original ideas.
Details of the EU legislation on electronic cigarettes were hammered out at a final meeting on 16 December. A team of MEPs from all political groups met with representatives of the Council of Ministers (the EU governments) and the European Commission to negotiate an agreement. Late in the evening they reached a deal. The details of this new legislation are now publicly available in a new Article 18a of the Tobacco Products Directive and can be found at the bottom of this email.
The making of EU laws involves negotiations between different institutions each of which has a different perspective, representatives of 28 different countries, and representatives with very different political views. Everyone including manufactures will recognise that the changes made to the original proposals in this case were remarkable.
Article 18, as proposed by the European Commission, was very short. It said that all nicotine-containing products had to be classified as medicines and regulated as such, unless their nicotine concentration was less than 4mg per ml. Pharmaceutical regulation could have led to very severe restrictions being placed on the development and marketing of e-cigs in some countries.
But the European Parliament’s negotiators succeeded in having the proposal entirely re-written. The new Article 18a on electronic cigarettes removes all reference to the pharmaceutical approach. Instead it treats e-cigs as consumer products that will be subject to the usual product safety requirements demanded of every manufacturer, but also with some specific restrictions intended to meet concerns that have been expressed.
I know that some e-cig users object to some of these restrictions, and I have much sympathy for the view that e-cigs are likely to do much less harm than tobacco cigarettes so restrictions may be counter-productive. But the fact is that the governments of Europe (including the British government) have not accepted this argument. The UK government had already indicated in June 2013 that they would follow the medicinal route for the regulation of e-cigarettes. They regard e-cigs as potentially dangerous recreational drugs that may increase addiction to nicotine and become a gateway for young people to start smoking.
Whether you disagree with this view or not it is the position that has been taken by the elected governments in virtually every EU country. This is the context in which negotiations took place. MEPs negotiating on behalf of the European Parliament succeeded in overturning the original proposals in the face of such resistance. The fact that they are trying to prevent individual governments (including the UK) from regulating e-cigs even more severely means that I think they deserve more credit than some in the e-cig industry are giving them.
So what’s in the new law?
The legislation imposes various requirements on e-cig manufacturers intended to provide public information about the ingredients and to address safety concerns. If manufacturers have evidence that particular products do not meet good safety or quality standards they are legally obliged to withdraw or recall them, just as food manufacturers have to do if they find a product is contaminated.
Article 18a also bans the advertising of e-cigs and promotional sponsorship by e-cig makers. The manufacturers have a commercial interest in wanting to advertise and so oppose these restrictions, but personally I think they will just move from advertising to PR. No doubt thousands of articles and TV items about the benefits of e-cigs compared to tobacco will continue to be produced and there is no ban on these.
E-cig users will be most aware of the following:
- Refillable containers are permitted but cannot contain more than 10ml of liquid; single use cartridges shall not exceed a volume of 2ml;
- The liquid must not contain nicotine in excess of 20mg/ml (probably the most controversial part of the entire package, but a huge improvement on the 4mg/ml originally proposed);
- Refillable containers must be child-proof, and new designs must be introduced to ensure leakage-free refilling;
- A wide range of flavourings will continue to be available (see below).
Many of the fears are groundless
Since the agreement was reached various e-cig manufacturers and e-cig users have expressed concerns about the way in which parts of the legislation COULD be interpreted. Having spoken with the European Commission officials most closely involved my feeling is that these concerns are misplaced. I get the sense that the Commission knows that there are details still be resolved, knows that it must talk with e-cig makers about some of these, but has no wish at all to go against the spirit of what has been agreed.
So far the following specific issues have been raised with me.
Individual governments could still adopt medicines regulation for e-cigs
This is true, they COULD do so; a government can classify any product as a medicine whenever it likes and the new law doesn’t change this. However, with an EU law that provides for quality and safety standards of e-cigs there is no need for them to do so. Governments could face a legal challenge in the European Court of Justice if they are unable to justify a decision to classify e-cigs as pharmaceuticals.
Even so, campaigners should now focus attention on the policy of individual governments, some of which will hardly be aware that the new EU arrangements are being made.
Refillables could be banned
Article 18a says that if a given type of refill container has been banned by at least three governments the European Commission can introduce an extra legal provision, known as a ‘delegated act’ to extend the ban across Europe, “if that measure is justified and proportionate”. In practice the Commission has the right to propose new legislation banning products on health and safety grounds whenever it likes, but that doesn’t mean it has any wish to do so. Any such proposal would have to secure the support of a majority of governments, could also be overturned by the European Parliament, and could face a legal challenge if it was not “justified and proportionate”. As things stand the Commission has no wish to propose any such bans.
Flavours could be banned
In reality it looks as though a very wide range of flavours will be available. (delete first sentence sentence). The decision is, in theory, a competence of national governments, but the legislation says that any prohibitions would have to be legally justified. The principle of mutual recognition should also apply, so that flavours permitted in one country should be permitted across the EU. For a host of legal reasons the banning of particular flavours could prove very difficult.
Consistent dosing
The legislation says that e-cigs must deliver doses of nicotine "consistently", but manufacturers point out that in practice this may vary with the strength of the battery. Commission officials admit to having not yet given this practical problem any detailed consideration but suggest that something along the lines of "in normal operating practice" might be included within guidelines that will be produced at a later date.
Nicotine dosing
The legislation says that e-cig manufacturers must provide information on nicotine dosing and uptake when used under normal or reasonably foreseeable conditions. This has promoted concern that very expensive tests may be required. European Commission officials say that the aim should be to inform people how much nicotine an average e-cig user is likely to get in their blood stream. They say that this should be a national matter but accept that this might lead to different criteria being applied across Europe. In conversation they have accepted that official guidance for manufacturers will have to be prepared, but say this will be low on their list of priorities and there will be plenty of time for e-cig manufacturers to make suggestions.
Mechanism for leak-free filling
The legislation insists that e-cigs and refill containers should incorporate a mechanism to ensure leakage-free refilling. Given that the liquid is highly toxic I think this is a worthy ambition but it is true that there is not yet a widely available solution to achieve this. Those who insisted on the wording do not seem to have given thought to how it is to be achieved in practical terms. Commission officials are scratching their heads too, but say that they will carry out a study to assess possible ways forward and look at other sectors where similar problems have been addressed . They also tell me that they will consult with e-cig manufacturers.
Cross-border and online sales
The legislation uses the same rules for cross-border sales as currently apply to tobacco products; a proposed ban on online sales was not agreed. The reality is that online sales are very hard to curb even if there was a desire to do so.
Can the legislation be defeated?
A number of e-cig users and manufacturers say that the legislation should be defeated. This remains a possibility and I will be discussing this with colleagues next week, but at the moment I am worried that it could result in pharmaceutical controls or outright bans on e-cigs quickly being introduced by a number of European governments. It could, in my view, make the situation worse but I will look at this carefully.
Negotiators representing a majority of MEPs in the European Parliament shook hands on the deal with the representatives of the governments on the night of 16 December. The deal has since been endorsed by the governments, but it will not be put to a vote in the Parliament until late February or March.
Although MEPs refused to accept restrictions on e-cigs when they last voted on the issue, the circumstances have now changed. The Parliament has got 80% or more of what it wanted through the negotiations. I don’t think there is a high likelihood that they will reject the deal now. They know very well that were they to do so they would probably end up with a much worse outcome.
Apart from anything else the e-cigs rules are part of the Tobacco Products Directive, which introduces controls on the packaging and promotion of cigarettes. With the Parliament’s 5-year term about to end, a great many MEPs want to see this legislation agreed before the elections so they are probably not going to put it at risk.
I will talk to my fellow MEPs about this but I wanted to be honest with you and not make any promises until I know I can achieve them.
Stop Press
As I was writing this I was passed a letter by one of the scientific researchers quoted by the Commission in their justification of the 20mg/ml limit on eliquid nicotine concentrations. He is of the opinion that there are major problems in the way officials have interpreted his scientific research. I am not a scientist myself (I have staff who are but not specialists) but I am looking carefully at this and will take it up directly with the Commission. If there is a major problem I will look carefully at how this affects my support for the deal. The scientist concerned only issued his open letter this afternoon but I will push for further information and will let you know as soon as I know what difference this could make. You should keep this in mind when reading the rest of this email!
What to do now?
In the longer term supporters of e-cigs will want a proper review of all the health evidence and a recast of the legislation, not least to permit use of a higher strength of nicotine. But that is likely to be years off.
The immediate priority must be to get some strong assurances from the European Commission about the way they intend to interpret the legislation. I intend to write to Commissioner Borg, who deals with public health matters, about this next week.
And we need to know how national governments are going to respond to the new framework. Some of them are still spouting the old mantra about pharmaceutical legislation and don’t seem to have realised that the ground has shifted. Pressure needs to be applied to get the best possible interpretation of the rules in each country, and to avoid the need for costly legal action to be taken against them at a later date.
Chris Davies MEP
Liberal Democrat environment and public health spokesman
Text of Article 18a
TITLE III – ELECTRONIC CIGARETTES
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Article 18a
Electronic cigarettes
1. The Member States shall ensure that electronic cigarettes and refill containers are only placed on the market if they comply with the relevant provisions of this Directive and with all other relevant Union legislation.
This Directive does not apply to electronic cigarettes and refill containers that are subject to an authorisation requirement under Directive 2001/83/EC or to the requirements set out in Directive 93/42/EEC.
2. Manufacturers and importers of electronic cigarettes and refill containers shall notify the product with the competent authorities of the Member States in which the product is intended to be placed on the market. The notification shall be submitted in electronic form 6 months before the intended placing on the market. For products already placed on the market on the date referred to in paragraph 1 of Article 25, the notification shall be submitted within 6 months of that date. A new notification shall be submitted for each substantial modification of the product.
The notification shall, depending on whether the product is an electronic cigarette or a refill container, contain the following information:
a. name and contact details of the manufacturer, a responsible legal or natural person within the European Union, and, if applicable, the importer into the European Union;
b. list of all ingredients contained in and emissions resulting from the use of the product, by brand name and type, including quantities thereof;
c. toxicological data regarding these ingredients and their emissions, including when heated, referring in particular to their effects on health of consumers when inhaled and taking into account, inter alia, any addictive effect;
d. information on nicotine dosing and uptake when used under normal or reasonably foreseeable conditions;
e. description of the components of the product; including, where applicable, the opening and refill mechanism of the electronic cigarette or refill containers;
f. description of the production process including series production and declaration that the production process ensures conformity with the requirements in this article;
g. declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably foreseeable conditions.
Where Member States consider that data are incomplete, they are entitled to request the completion of such data.
Proportionate fees may be charged by Member States for receiving, storing, handling and analysing the information submitted to them.
3. Member States shall ensure that:
a) nicotine-containing liquid is only placed on the market in dedicated refill containers not exceeding a volume of 10 ml, in disposable electronic cigarettes or in single use cartridges and that the cartridges or tanks do not exceed a volume of 2 ml;
b) the liquid does not contain nicotine in excess of 20 mg/ml;
c) the liquid does not contain additives listed in paragraph 4 of Article 6;
d) only ingredients of high purity are used in the manufacture of the liquid; substances other than the ingredients referred to in paragraph 2(b) are only present in trace levels, if they are technically unavoidable during manufacture;
e) only ingredients are used in the liquid that are not hazardous to human health in heated or unheated form, with the exception of nicotine;
f) electronic cigarettes deliver the nicotine doses consistently;
g) electronic cigarettes and refill containers are child- and tamperproof; electronic cigarettes and the refill containers are protected against breakage and leakage and have a mechanism ensuring leakage free refilling.
4. Member States shall require manufacturers and importers to ensure that:
(a) unit packets of electronic cigarettes and refill containers include a leaflet with information instructions for use and storage, including a reference that the product is not recommended for use by young people and non-smokers, contra-indications, warnings for specific risk groups, information on possible adverse effects, on addictiveness and toxicity, and contact details of the manufacturer or importer and a legal or natural contact person within the European Union;
(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;
iii. carry one of the following health warnings:
'This product contains nicotine which is a highly addictive substance. It is not recommended for use by non-smokers'.
or
'This product contains nicotine which is a highly addictive substance.'
Member States shall determine which of these health warnings are used.
(c) the health warnings shall comply with the provisions in paragraph 2 of Article 11.
5. Member States shall ensure that:
a) commercial communications with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers are prohibited in information society services as defined in Article 1(2) of Directive 98/48/EC, in the press and other printed publications, with the exception of publications that are intended exclusively for professionals in the trade of the products and for publications which are printed and published in third countries, where those publications are not principally intended for the European Union market;
b) commercial communications with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers are prohibited in the radio;
c) any form of public or private contribution to radio programmes with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers is prohibited;
d) any form of public or private contribution to any event, activity or individual with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers and involving or taking place in several Member States or otherwise having cross-border effects is prohibited;
e) audiovisual commercial communications falling under Directive 2010/13/EU are prohibited for electronic cigarettes and refill containers;
f) cross-border distance sales of electronic cigarettes and refill containers are regulated in accordance with Article 16.
6. Member States shall require manufacturers and importers of electronic cigarettes and refill containers to submit to competent authorities on an annual basis comprehensive data on sales volumes, by brand name and type, as well as information on preferences of various consumer groups, including young people, non-smokers and main types of current users, as well as the mode of sale of the products. They shall also submit executive summaries of any market surveys carried out in respect of the above, including an English translation thereof.
Member States shall monitor the development of the electronic cigarette market as well as the market for refill containers, including any evidence of gateway use among young people and non-smokers.
7. Member States shall ensure the dissemination of information received pursuant to paragraph 2 on a website with due regard to the protection of trade secrets.
Member States shall make available, upon request, all information received pursuant to this Article to the Commission and other Member States. Member States and the Commission shall ensure that trade secrets and other confidential information are treated in a confidential manner.
8. Member States shall require that manufacturers, importers or distributers establish and maintain a system to collect information about all suspected adverse effects. If any of these operators considers or has reason to believe that electronic cigarettes or refill containers, which are in its possession and are intended to be placed on the market, are not of good safety or quality or is otherwise not in conformity with this Directive, the operator shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it, as appropriate. In such a case the operator shall also be required to immediately inform the market surveillance authorities of the Member States in which the product is made available, giving details, in particular, of the risk to
health and safety and of any corrective action taken, and of the results of such corrective action. Member States may also request additional information from the operator, for example on safety and quality aspects or any adverse effects.
9. The Commission shall report on the potential risks to public health associated with the use of refillable electronic cigarettes at the latest on the date referred to in Article 25(1) and whenever needed thereafter.
10. In the case of products meeting the requirements of this Article, where a competent authority ascertains or has reasonable grounds for concerns that a given electronic cigarette or a refill container, or a type of electronic cigarettes or refill containers, could present a serious risk to human health, it may take appropriate provisional measures and shall immediately communicate to the Commission and the competent authorities of other Member States the measures taken and any supporting data. The Commission shall determine, as soon as possible, whether the provisional measure is justified. The Commission shall inform the Member State concerned of its assessment, in order for the Member State to ensure appropriate follow-up.
Where, in the application of the first subparagraph of this paragraph, a given type of electronic cigarette or refill container, or a type of electronic cigarettes or refill containers has been banned on justified ground by at least three Member States, the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to extend such a ban to all Member States, if that measure is justified and proportionate.
11. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the wording of the health warning in paragraph 4(b). When adapting that health warning, the Commission shall ensure that it is factual.
12. The Commission shall adopt by means of implementing acts a common notification format pursuant to paragraph 2 and the technical standards of the refill mechanism.
These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21.