Germany

The Federal Non-Smokers Protection Act (FNSPA) restricts smoking in federal facilities, constitutional offices, and public train stations. The FNSPA does not define the terms “smoke or ”smoking,” yet the federal government has stated that e-cigarette use is prohibited in the same manner as smoking under the FNSPA. Therefore, the regulatory status code “Some Restrictions” is given.

The law prohibits or restricts certain forms of advertising and promotion of tobacco and related products, which is defined to include e-cigarettes and refill containers. As such, the same provisions regulating advertising and promotion of tobacco products also apply to e-cigarettes and refill containers. However, many forms of advertising and promotion fall outside of the ban and restrictions, including point of sale advertising and advertising through the mail. Therefore, the regulatory status code "Some Restrictions" is given.

The law prohibits certain forms of sponsorship of e-cigarettes and refill containers, including the sponsorship of radio and audiovisual/TV programs promoting the sale of e-cigarettes and refill containers. The law also prohibits the sponsorship of cross-border events promoting the sale of e-cigarettes and refill containers; specifically, events in which multiple EU Member States are involved, which take place in several EU Member States, or which otherwise have cross-border effects. However, if an event or activity takes place and has an impact, only in Germany, the law is interpreted as allowing sponsorship. In addition, the law does not prohibit contributions to “corporate social responsibility” programs. Therefore, the regulatory status code “Some Restrictions” is given.

The law does not address point of sale product display. Therefore, point of sale product display is allowed.

The law does not specifically prohibit or restrict the sale of e-cigarettes and refill containers through the internet; therefore, the law is interpreted as permitting internet tobacco product sales. The law requires retailers who engage in cross-border distance sales to use an age verification system and register with the competent authority. However, absent an explicit ban on the sale of e-cigarettes and refill containers through the internet, this requirement is not interpreted as prohibiting internet sales of these products.

The law does not directly prohibit the use of flavors in e-cigarettes or refill containers. However, the law prohibits the use of certain ingredients that pose a risk to human health (in heated or unheated form) in the e-cigarette or refill container liquid, including the following flavoring substances:

• Diacetyl (2,3-butanedione) (CAS No. 431-03-8)
• 2,3-pentanedione (CAS No. 600-14-6)
• 2,3-hexanedione (CAS No. 3848-24-6)
• 2,3-heptanedione (CAS No. 96-04-8)
• Coumarin

The law prohibits the sale of e-cigarettes and refill containers with the following ingredients:

• Vitamins or other additives that give the impression of having a health benefit or limited health risk;
• Caffeine or taurine or other additives associated with energy and vitality;
• Additives that have coloring properties for emissions;
• Additives that have carcinogenic, mutagenic or reprotoxic (CMR) properties in an unburned state; and
• Ingredients, other than nicotine, that pose a risk to human health in heated or unheated form, including flavoring substances and substances derived from plants.

The law requires that e-cigarette and refill container packaging display a text-only warning label covering 30% of both the front and back surfaces of the packaging and outer packaging. The warning must state read in German: "Dieses Produkt enthält Nikotin: ein Stoff, die sehr stark abhängig mach" ("This product contains nicotine: a highly addictive substance”).

The law requires that the following information be included on the packs and outer packaging of e-cigarettes and refill containers:

1. All ingredients in descending order of their weight percentage;
2. The nicotine content and nicotine delivery per dose;
3. Lot to which the product belongs; and
4. Statement that the product must not fall into the hands of children and young people.

In addition, an information leaflet must be included in the e-cigarette and refill container packs that includes:

1. Instructions for storage and use;
2. Contraindications;
3. Warnings that the product is not recommended for non-smokers and distribution to and use by children and young people is prohibited;
4. Information about possible adverse side effects;
5. Information on the addictive effect;
6. Information on toxicological data; and
7. Contact details for the manufacturer or importer or a responsible legal or physical person in the EU.

The law also prohibits the use of misleading packaging information on e-cigarette and refill container packs, outer packaging and the product itself. Misleading information includes implying health benefits, creating the impression that it is less harmful than other products, and bearing resemblance to medication, food or cosmetic products.

The law prohibits the sale of e-cigarettes and refill containers with nicotine levels higher than 20mg/ml.

The law requires e-cigarettes and/or refill containers adhere to the following:

1. Refill containers have a maximum volume of 10 ml
2. Disposable e-cigarettes or disposable cartridges have a maximum volume of 2 ml
3. The nicotine is delivered at a constant level under normal conditions of use
4. Products are child-proof, tamper-proof, break-proof, leak-proof and have a mechanism for leak-free refilling.

The law requires refill mechanisms to meet the requirements of the Commission Implementing Decision (EU) 2016/586, Article 2(1). Refill mechanisms must use securely attached nozzles at least 9 mm long which are narrower than and fits easily into the opening of the tank of the e-cigarette. The flow mechanism must emit no more than 20 drops of refill liquid per minute when placed vertically and subjected to an atmospheric pressure alone at 20°C ± 5°C. Alternately, the refill mechanism may operate by means of a docking system which only releases refill liquids into the tank of the e-cigarette when the e-cigarette and refill container are connected.

The law requires manufacturers and importers of e-cigarettes or refill containers to notify the relevant regulatory agency 6 months before the product is placed on the market. The notification must include the contact details for the manufacturer or importer or a responsible legal or physical person in the EU, the ingredients and emissions for the product, information on the nicotine dose and intake, a description of the product’s components, and a description of the manufacturing process.

The law also requires that manufacturers and importers submit annual reports for the e-cigarettes and refill containers containing the sales volume data, information on the preferences of consumer groups and type of sale, and summaries of market research.

The Youth Protection Act restricts the use and placement of vending machines containing e-cigarettes and refill containers. E-cigarettes and refill containers can only be sold by vending machines if (1) the location is not accessible to children or adolescents or (2) the vending machine is under constant supervision or has some sort of technical/mechanical device that ensures children and adolescents cannot make a purchase.

The law requires retailers who engage in cross-border distance sales to register with the competent authority.