Rebecca Taylor: E-cigarettes – The current state of play following last night’s negotiations

Negotiations between MEPs and national governments represented by the Lithuanian Presidency on how best to regulate e-cigarettes effectively came to an end last night (Monday 17th December). Further negotiations will take place tomorrow between all EU governments who must approve on the deal reached, which will then be subject to a final vote in the European Parliament next spring.

The current state of play on these products following last night’s negotiations is:

- E-cigs are defined as a “product for consumption” and not as a medicinal product.

-E-cigs are to be regulated according to the provisions of Article 18 of the Tobacco Products Directive concerning nicotine containing products.
-There is an exemption for products “subject to an authorisation requirement” under the Directives for medicinal products or medical devices. This essentially means that Member States could apply pharmaceutical legislation, but only if they can justify it. They are likely to encounter the problem of legal challenges referencing the EU law specifically tailored to e-cigs.

-Flavourings will not be regulated at EU level. Member States can regulate them but may not ban flavours allowed in another Member State as EU treaties forbid trade restriction in the single market.

Cross-border Sales
-Will be allowed according to Article. 16 of the TPD

-All current types of e-cigs are allowed (disposable, refillable by means of a refill container or rechargeable with single use cartridges)
-In case a national competent authority finds evidence that specific electronic cigarette
products or refill containers present a serious risk to human health, it can take appropriate measures and communicate that to the Commission and other Member States. The Commission will then assess the evidence and justifications. If such measures are taken in three or more Member States (who apply the TPD to e-cigs and not pharma legislation), the Commission will be empowered to extend these measures to products in all Member States. But this could then be blocked by a majority of MEPs in the European Parliament.

Product requirements
-Refill containers for nicotine-containing liquid may not exceed a volume of 10ml.
-Disposable cigarettes or single use cartridge for nicotine-containing liquid may not exceed a volume of 1ml.
-The liquid may not contain more than 20mg/ml nicotine.
-E-cigs and refill containers need to be child and tamper-proof. They need to be protected against breakage & leakage and have a mechanism ensuring leakage-free refilling.

Labelling and consumer information
-E-cig packs need to include a leaflet with instructions for use and information on potential adverse effects.
-There needs to be a reference that the product is not recommended for the use of young people and non-smokers.
-Unit packs need a list of all ingredients and detailed information on the nicotine dosage.
-The packs need to carry one of two health warnings.

Advertising and promotion
-Will be prohibited in press and other printed publications, in the radio or on TV (with exception for publications for trade professionals).

Detailed reporting obligations
-Will apply to manufacturers and importers while Member States shall monitor the market development, including on evidence for gateway use of young people.

Significant ground had been won in the rejection of Europe wide medicines licensing. But the decision to potentially ban refillable cartridges and devices in future would be a backward step.

The fight is now on to show that it would not be justifiable to ban refillable cartridges on health and safety grounds.

4 thoughts on “Rebecca Taylor: E-cigarettes – The current state of play following last night’s negotiations

  1. Will cross-borders sales really be allowed? Article 16 of the TPD was amended on 8 October and now says “Member States shall prohibit retail outlets established on their territory from engaging in cross border distance sales.”

  2. Indeed Alan. Please Rebecca, do not take us for retards, we are all grown-ups who learned to read in primary school, so give us the text that has been agreed upon and we will decide for ourselves if we should be outraged or claim victory.

  3. Just my 2 cents in short and in plain English from the bits and bobs that fly around:

    1) Countries that want to ban the e-cig are allowed to do so by violating medicinal law; but the risk exist this will be successfully challenged in court.
    2) Countries that want to give it a try by making up health and safety claims and by blowing things out of proportion about refillables may ban the e-cig that way.
    3) Countries that do not want to ban the e-cig may do so as well, for the time being.

    The main goal of the TPD is to equalise the internal market. Therefore if 3 out of 28 countries have found sufficient bogus threats on refillables they will be banned throughout the whole of the EU by delegated act of the commission in 2 years time.

    But in the meantime all member states are encouraged to minimize the growth of the e-cig use by banning flavours.

    What a breaktrough indeed; we came from banning the e-cig by violating the law; and that would be challenged and overruled in court almost certain, to it will be banned in 2 years time and parliament has no say in it. And MEP’s under pressure of having to reject the whole TPD have to accept this hostage taking by the commission.