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Whether you're a vape brand, manufacturer, distributor, or retailer, our guide provides a comprehensive overview of the key regulatory requirements in Germany. With our expert services, you can ensure that your products meet all compliance standards, saving you time and money.
Through this article, you will learn:
1. Overview of E-cigarette Regulation in Germany
2. The Regulatory Framework for E-cigarettes in Germany
3. Key Regulatory Agencies
4. Product and Packaging Requirements
5. Retail Channel Restrictions
6. Vape Taxation
7. Product Notification
8. Advertising and Marketing
9. Violation Cases
Overview of E-cigarette Regulation in Germany
Germany's regulatory burden for e-cigarettes is moderate compared to other EU countries. Online sales are allowed, and product notification is free of charge. Nicotine-free e-liquids are regulated similarly to nicotine-containing ones, and there are currently no flavor restrictions. However, outdoor advertising of e-cigarettes will be banned starting from January 1, 2024. Additionally, a bill is under discussion in Parliament to extend vaping restrictions in vehicles where minors or pregnant women are present. The tax on e-liquids is set to gradually increase, making it one of the highest in the EU by 2026.
It is expected that there will be increasing restrictions on marketing and sponsorship by the current government, which will be in power until 2025. A ban on disposable e-cigarettes due to improper waste management is also likely in the near future. The federal council has already called for an effective ban on these products at the national and EU levels. Additionally, further restrictions such as plain packaging and a ban on child-appealing flavors are anticipated as part of the ongoing revision of the EU Tobacco Products Directive (TPD).
Basic Data for Germany
State Structure: Federal parliamentary republic
Government: The President is Frank-Walter Steinmeier, and the Chancellor is Olaf Scholz, both from the center-left Social Democracy Party (SPD). The next national election is in 2025.
Population: 84.5 million(2024)
GDP Per Capita: $48,562 (2022)
Smoking Population: 20.1 million (29.9% of men, 26% of women)
Vaping Population: 1.4 million (2% of the 18+ population)
The Regulatory Framework for E-cigarettes in Germany
The Tobacco and Related Products Act (Tobacco Act or TabakerzG) regulates e-cigarettes with and without nicotine and refill containers as tobacco-related products. The Tobacco and Related Products Ordinance (Tobacco Ordinance or TabakerzV) provides specific guidance, such as notification, packaging, and warning requirements. General consumer and safety regulations, such as the Consumer Goods Ordinance, the Civil Code, the Product Safety Act, the Product Liability Act, and the Market Surveillance Act, apply to e-cigarettes. Hardware and disposables must comply with the Battery Act and the Electrical and Electronic Device Act.
The BVL oversees the regulation of tobacco products, including e-cigarettes, ensuring that all products meet safety and quality standards. The BVL also monitors compliance with labeling and advertising restrictions.
Federal Ministry of Finance (BMF)
The BMF is responsible for the implementation and collection of tobacco taxes on e-cigarettes.
Federal Institute for Risk Assessment (BfR)
The BfR conducts research on the health risks associated with e-cigarettes and provides scientific advice to regulatory bodies.
Federal Tax Office (BZSt)
The BZSt manages the registration of e-cigarette products for tax purposes and ensures that manufacturers and importers comply with the tax regulations.
Product and Packaging Requirements
Hardware
- Refill containers must be less than 10 ml.
- Disposable e-cigarettes or single-use cartridges are limited to 2 ml.
- Refillable tank volumes are unrestricted.
- All e-cigarettes and e-liquids, regardless of nicotine content, must be child-proof, tamper-proof, and protected against leakage or breakage, especially during refilling.
Refill Mechanisms
E-cigarettes may only be sold with specific refilling mechanisms, as outlined in the Commission Implementing Decision (EU) 2016/586:
- A nozzle at least 9 mm long, narrower than the tank opening of the e-cigarette, and with a flow control mechanism emitting no more than 20 drops per minute when placed vertically under normal atmospheric pressure.
- A docking system that releases refill liquids only when the e-cigarette and refill container are connected.
Suppliers must ensure that both e-cigarettes and e-liquid containers are sold with clear refilling instructions, including diagrams that indicate nozzle width or tank opening size to ensure compatibility and safety during refilling.
Ingredients
Under the Tobacco Ordinance, e-liquids must not exceed a nicotine concentration of 20 mg/ml (2%). The following additives are banned in e-liquids:
- Vitamins or other additives that suggest health benefits or reduced health risks (e.g., amino acids, carnitine, flavonoids, antioxidant phospholipids, selenite).
- Caffeine, taurine, or other stimulants are associated with energy and vitality, including maltodextrin, glucose, coffee plant extracts, and thujone.
- Additives that color emissions.
- Carcinogenic, mutagenic, or reprotoxic (CMR) substances.
Additionally, the BfR has recommended that additives such as guar gum, sorbitol, safrole, sucralose, and menthol, which may still pose health risks, should also be banned.
Labelling and Packaging Requirements
Health Warning
Each unit packet and outer pack of both nicotine-containing e-cigarettes and refill containers must carry a health warning in German on the front and back surfaces, covering 30% of the area. The warning states, "Dieses Produkt enthält Nikotin: einen Stoff, der sehr stark abhängig macht." (This product contains nicotine, which is a highly addictive substance.)
Packaging
Unit packs and outside packaging must include:
- A list of ingredients in descending order by weight
- Nicotine content and delivery per dose
- Batch number
- A warning against the product reaching children and adolescents
The Tobacco Ordinance stipulates that packaging must not encourage consumption, imply health benefits, or resemble food or cosmetic products.
Leaflet
Unit packets must include a leaflet in German with instructions for use, storage, warnings, and contact information for the manufacturer or importer.
Retail Channel Restrictions
Allowed under the Tobacco Act, provided retailers have an age-verification system ensuring consumers are at least 18. Sales from vending machines are restricted.
It is illegal to sell e-cigarettes from vending machines unless they are located in areas inaccessible to children and adolescents, including nicotine-free products.
Retailers must complete a form and submit it electronically to the BVL, providing:
- Retailer or company name, and trading name if different.
- Principal business address.
- Date of first or intended cross-border product supply.
- Website address where the product is or will be offered.
- Details of the age-verification systems.
- Any additional information required by the Federal Ministry of Food and Agriculture or the Federal Ministry of Finance.
Upon submission, the BVL will confirm registration. Selling products to consumers in other countries is allowed if the destination country's regulations are met, with nicotine-free e-liquids requiring only German registration.
Vape Taxation
A €0.20 per ml excise tax is levied on e-liquids, which will increase gradually to €0.32 per ml by 2026. Products must carry tax stamps, and e-cigarette hardware is subject to 19% VAT.
The Alliance for Tobacco-Free Enjoyment has filed a complaint to prevent future tax increases, but the outcome is still pending.
Product Notification
In Germany, the registration of e-cigarette products involves several steps, including notification, documentation submission, and potential testing. The fees and procedures vary depending on the type of product (e-liquids, hardware, or other components) and the scope of the registration (e.g., new product registration, substantial modification, etc.).
All documents must be submitted through the EU Common Entry Gate (EU-CEG) at least six months before the product is launched.
Applicable Companies
- Manufacturers: Companies producing e-cigarette products within the EU.
- Importers: Must be registered companies within Germany, responsible for importing products from outside the EU.
- Brand Owners: Companies that own and sell e-cigarette brands but do not directly manufacture or import them.
Information Requirements
- Manufacturer/Importer Information: Must include the name and contact details of the manufacturer, importer, or other responsible entity in the EU.
- Ingredient List and Emissions: Provide a complete list of ingredients and emissions by brand and variant, including quantities.
- Toxicological Data: Include data on the ingredients' effects, particularly when heated, and their impact on health and addiction.
- Nicotine Information: Detail the nicotine dose and absorption under normal use conditions.
- Product Description: Describe product components, opening, and refill mechanisms (if applicable).
- Production Process: Ensure the description complies with all relevant laws.
- Quality and Safety Responsibility: Include a declaration that the manufacturer assumes full responsibility for the product’s quality and safety.
All information must be provided for each brand name and product type.
The registration process typically takes 4-6 weeks, depending on the completeness of the application and the type of product. However, the approval timeline may be extended if additional documentation or testing is required, potentially lengthening the entire process to over 3 months. Therefore, businesses should allocate sufficient time to ensure the registration process is completed smoothly.
Substantial Modification
A new notification is required if a product is substantially modified, which includes changes in composition or components.
Market Data Notification
Companies must submit an annual report by June 30th each year, providing comprehensive data on sales volumes, consumer preferences, and market surveys.
System to Collect Information about Adverse Health Effects
Producers must establish a system to collect information about suspected adverse effects on health and take necessary corrective actions if a product is deemed unsafe or non-compliant.
Advertising and Marketing
Germany's Tobacco Act, along with possible regional regulations, imposes strict controls on e-cigarette advertising, promotion, and sponsorship:
Prohibited Advertising Channels
- No ads on the internet, radio, TV, or most print media, except those aimed at industry professionals or published outside the EU.
- No teleshopping or product placements.
- No free samples outside specialist stores.
- No cinema ads for films targeting under-18s.
Content Restrictions
Ads must not appeal to minors, suggest health benefits, or imply that e-cigarettes are safer than tobacco products.
Sponsorship Restrictions
Forbidden in audiovisual media and events with cross-border EU impact.
Allowed Marketing Options
- Domestic sponsored events.
- Appearance of products in films/TV without direct promotion.
- Point-of-sale advertising, including displays in retail stores.
- Free sampling only inside specialist stores.
Violation Cases
Tax Law Violation: At the 2023 Stuttgart E-Cigarette Expo, German customs officials confiscated products from several booths, including the "Juice N Power" brand, for not paying required taxes. The booth was shut down, and two other exhibitors were expelled by police for refusing to pay fines.
Notification Obligation Violation: In a 2018 Hamburg court ruling (Case No. 416 HKO 39/18), it was confirmed that importers must notify products through the EU-CEG six months before market entry, even if previously notified by the manufacturer. Non-compliance may result in fines up to €30,000.
Labeling and Packaging Violations: In January 2018, Joyetech's eGO AIO Pro C was removed from the German market for insufficient child-proof packaging under TPD.
Cross-Border Sponsorship Violation: An e-cigarette company was fined €30,000 for sponsoring music events in multiple EU countries, violating sponsorship restrictions.
How Hangsen Can Help You Start Your Business
1. End-to-End E-Liquid Solutions: Hangsen provides comprehensive support throughout the entire process, from flavor development and testing to packaging design and distribution.
2. Flavor Customization: With years of experience, Hangsen excels at creating custom flavors that cater to the preferences of European consumers, including those in Germany.
3. Regulatory Compliance: Hangsen offers expert guidance on adhering to German and EU regulations, ensuring that your products meet all legal requirements.
4. Logistics Support: Hangsen works with trusted logistics partners in Europe, providing efficient and reliable delivery services to support your supply chain operations.
For more service information, please contact us at service@hangsen.com
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Bar Salt White Label E-liquid Solution
HANGSEN INTERNATIONAL GROUP
Hangsen is a world-leading e-liquid manufacturer, offering custom flavor solutions for vape devices and premium white-label e-liquid services. Our e-liquids are renowned for their high consistency, stability, safety, and regulatory compliance. With business operations spanning over 80 countries and regions worldwide, Hangsen continues to set industry standards.
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