Netherlands

Policy Summary: 

Nicotine-containing and non-nicotine e-cigarettes and e-liquids are regulated under the amended Tobacco and Smoking Commodities Act (and delegated legislation: the Tobacco and Smoking Commodities Decree and the Tobacco and Smoking Commodities Order). Manufacturers of e-cigarettes may opt to apply for a medical license. If such a license is granted, the rules governing medicinal products apply (and the rules governing tobacco related products no longer apply). So far, no license to market e-cigarettes as medicinal products has been granted in the Netherlands.

The Tobacco and Smoking Commodities Act contains a requirement to notify the competent authority prior to introducing e-cigarettes and e-liquids with nicotine to the market. A new notification should be submitted whenever a substantial modification is made to the product. Manufacturers or importers must also annually submit  comprehensive data on sale volumes to the competent authority as specified in the law.

Sale of nicotine-containing and non-nicotine e-cigarettes to minors (under 18 years) is prohibited. Vendors must verify the age of buyers when they are not clearly older than 18 years. Retailers who engage or want to engage in cross-border sales of e-cigarettes and e-liquids with nicotine must register with the competent authority 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 (with nicotine-containing e-liquid) must not exceed 10mL. E-liquid with nicotine 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 of nicotine e-cigarettes must contain health warnings and constituent information as specified in the law. The warning “Dit product bevat de zeer verslavende stof nicotine. Het gebruik ervan wordt afgeraden voor niet-rokers” (“This product contains nicotine which is a highly addictive substance. It is not recommended for use by nonsmokers”) must appear on 30% 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. In addition to the health warnings and constituent information on the packaging, a leaflet should be added to all unit packs, containing instructions for use and storage, warnings for specific risk groups (such as pregnant women), and information on possible adverse effects as well as on addictiveness and toxicity. There are provisions that restrict the use of the packaging for advertisement or promotional purposes (e.g. pack must not contain misleading elements such as elements suggesting health or lifestyle benefits).

As a general rule, e-cigarette and e-liquid advertisement is prohibited, however there are some exceptions (e.g. advertising is permitted in tobacco or e-cigarette specialist shops). It is prohibited to give away free samples of e-cigarettes. Nicotine-containing and non-nicotine e-cigarettes or refills must not bear a name, mark, symbol or any distinctive feature of tobacco products, and vice versa. 

Product Classifications: