Policy Summary: 

Non-nicotine e-cigarettes are regulated as consumer products, while nicotine-containing e-cigarettes and refill containers are regulated by the European Union (Manufacture, Presentation and Sale of Tobacco and Related Products) Regulations 2016 (S.I. No. 271 of 2016), which transposed the Tobacco Products Directive 2014/40/EU.

The regulations require existing and new products (prior to being placed on the market) to be notified to the competent authority, the Health Service Executive and to be in compliance with a range of product specifications including on pack warnings. Manufacturers or importers must also submit an annual report to the Executive as specified in the law.

Retailers who engage or want to engage in cross-border distance sales of e-cigarettes must register with the Executive and with the competent authority in the Member State where actual or potential consumers are located.

Nicotine content of e-liquid must be less than or equal to 20mg/mL. E-cigarette tanks must not exceed 2mL, and volume of refill bottles must not exceed 10mL. E-liquid should not contain certain additives, and only high quality ingredients should be used in their manufacture. Except for nicotine, only ingredients that do not pose a risk to human health in heated or unheated form can be used in the nicotine-containing e-liquid. E-cigarettes must be able to deliver a dose of nicotine at a consistent level under normal conditions of use.

E-cigarettes and refill containers should be child- and tamper-proof, protected against breakage and leakage, and have a mechanism that ensures filling without leakage. Product packaging must contain health warnings and constituent information as specified in the law. The warning “Cuimsíonn an táirge seo nicitín, ar substaint an-andúile é.” “This product contains nicotine which is a highly addictive substance” must appear on 32% of each of the two largest surfaces of the unit packaging and any other packaging; must be in black Helvetica bold font on a white background; text must be centralized, occupy greatest possible proportion of the area reserved for it, and be parallel to the main text on the surface reserved for the warning. There are provisions that restrict the use of the packaging for advertisement or promotional purposes.

Cross-border advertising, promotion and sponsorship is prohibited.

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