New Regulations to impact the Irish E-Cigarette Industry

The World Health Organisation (WHO) has released a report advising governments to ban the use of e-cigarettes in public places and to outlaw tactics designed to lure young users. The WHO has also expressed concern about the growing role of the powerful tobacco industry in the e-cigarette market, which the WHO valued last year at US$3 billion. While these recommendations are not binding they may serve as a reference point for policy makers as they attempt to regulate for these new products.

The sale of e-cigarettes or e-liquids as consumer products (contrasted to the sale of products held out to be smoking cessation products) is not currently specifically regulated in Ireland. However, a directive has recently been adopted at EU level (the Directive) which shall bring such tobacco alternatives within the scope of EU and national regulation. Member States are obliged to implement the Directive by mid-2016. We have summarised the provisions of the Directive below.

1.  E-cigarettes

Electronic cigarettes, or e-cigarettes, are defined as being products that can be used for the consumption of nicotine-containing vapour. The e-cigarettes contain nicotine-containing liquid, or e-liquid, which, when heated, becomes an inhalable vapour.

2. Restrictions on nicotine levels 

The Directive provides that:

(a)  E-liquids may only be placed on the market in dedicated refill containers not exceeding a volume of 10ml or in disposable electronic cigarettes or in single use cartridges and that the cartridges or tanks do not exceed a volume of 2ml;
(b)  E-liquids do not contain nicotine in excess of 20 mg/ml;
(c)  E-liquids do not contain proscribed additives;
(d)  E-cigarettes must deliver nicotine doses at consistent levels; and
(e)  E-cigarettes and refill containers must be child and tamper proof, be protected against breakage and leakage, and have a mechanism that ensures refilling without leaking.

3. Information and Packaging

The Directive requires that packs of e-cigarettes and refill containers include leaflets with the following information:

(a)  either 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";
(b)  instructions for use, including that the product is not recommended for use by young people or non-smokers;
(c)  possible adverse effects; 
(d)  addictiveness and toxicity;
(e)  contact details of the manufacturer or importer; and
(f)  a list of ingredients

4. Advertisement and promotion 

Advertisement in the press, printed publications, on the radio or television, or sponsorship deals, shall be prohibited.

5.  Update

Upon adoption of the Irish Regulations, we will advise clients as to what restrictions and requirements will apply to their businesses going forward. We will prepare an update upon the adoption of the implementing regulations in Ireland. These regulations will implement the Directive with respect to the sale and distribution of e-cigarettes in Ireland. 

If you have any queries please feel free to contact Laura Greene or Colin Sainsbury.