Policy Summary: 

E-cigarettes are defined as “devices capable of releasing nicotine” and regulated by Royal decree 579/2017. The decree contains a requirement to notify the General Directorate of Public Health, Quality and Innovation, through the EU-CEG Portal prior to introducing a product to the market and notification requires compliance with a range of product specifications including on pack warnings. Manufacturers must also submit an annual report as specified in the decree to the General Directorate of Public Health, Quality and Innovation.

Nicotine content of e-liquid must be less than or equal to 20mg/mL. Single use e-cigarettes as well as 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 decree. Pack should contain a leaflet that includes, in addition to other things specified by law, a reference that the product is not recommended for use by young people and nonsmokers, a recommendation to keep the product out of the reach of children, and information on nicotine content and flavorings. The warning “Este producto contiene nicotina, una sustancia muy adictiva. No se recomienda su consumo a los no fumadores” (‘This product contains nicotine which is a highly addictive substance. It is not recommended for use by nonsmokers’) must appear on 30% of both the front and back surfaces of unit packaging and any other packaging; must be in black Helvetica bold font on a white background; text must be centralized, occupy entire area reserved for it, and be parallel to the main text on the surface concerned. There are provisions that restrict the use of the packaging for advertisement or promotion (e.g. pack must not contain misleading elements, including elements suggesting therapeutic, environmental, health or lifestyle benefits).

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