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.
-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.
-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.