Germany

Policy Summary: 

Nicotine-containing e-cigarettes are classified as tobacco related products and regulated by the Federal Government law on the Implementation of the Tobacco Products Directive and Related Products 2016 and by the ordinance on the implementation of the Tobacco Products Directive and related products 2016. Non-nicotine e-cigarettes are regarded as consumer products. Regulation requires specific reporting obligations on manufacturers and importers, and compliance with a range of product specifications including on pack warnings.

Retailers who engage or want to engage in cross-border sales of nicotine-containing e-cigarettes must register with the competent authorities in the Member State where actual or potential consumers are located, and meet other requirements (e.g. use an age-verification system) as specified in the law.

Nicotine content of e-liquid must be less than or equal to 20mg/mL. Single use e-cigarettes as well as single use e-cigarette tanks must not exceed 2mL, and volume of refill containers 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.

Nicotine-containing 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 a health warning and display a list of the ingredients, the nicotine content and delivery dose, the charge number and a warning that the product must be kept out of reach of children. The health warning “Dieses Produkt enthält Nikotin: einen Stoff, der sehr stark abhängig macht” (“This product contains nicotine which is a highly addictive substance.”) 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, and be parallel to the main text on the surface reserved for the warning. The package must not contain misleading information.

There are restrictions on e-cigarette advertising in print media (however, e-cigarette advertisement may be permitted in print media directed exclusively at professionals engaged in marketing e-cigarettes/tobacco products, as well as publications printed and published in non-EU countries). Advertising for e-cigarettes is prohibited in radio, TV and internet, sponsoring of e-cigarette via radio and TV, and of cross-border events is prohibited. Advertising on billboards is allowed.

In 2016, a change of the law for the protection of youth prohibited the sale of nicotine-containing and non-nicotine e-cigarettes and e-shishas to, as well as their use by, minors under 18 years.

Regulatory Mechanisms: 

Federal Government law on the Implementation of the Tobacco Products Directive and Related Products 2016 (http://www.webcitation.org/query?url=http%3A%2F%2Fwww.bmel.de%2FDE%2FErn...)

Act implementing the directive on tobacco products and related products (http://www.webcitation.org/query?url=http%3A%2F%2Fwww.bmel.de%2FSharedDo...)