2024-06-17
The Tobacco Products Directive (TPD) is a European Union directive that regulates the sale and marketing of tobacco and related products, including e-cigarettes and vaping products. The TPD was updated to include these products in May 2016 under TPD Article 20. Here are the key rules and requirements for vaping products under the TPD:
1. Product Composition and Design:
- Nicotine Content: E-liquids must not contain more than 20 mg/ml (2%) of nicotine.
- Bottle Size: E-liquid bottles can have a maximum volume of 10 ml.
- Tank Size: Tanks, cartridges, and pods must not exceed a capacity of 2 ml.
- Ingredients: Certain additives (like colorings, caffeine, and taurine) are banned. E-liquids must only contain high purity ingredients, and manufacturers must provide a list of all ingredients used.
2. Packaging and Labeling:
- Child-Resistant and Tamper-Evident: E-liquid packaging must be child-resistant and tamper-evident.
- Health Warnings: Packaging must include a health warning covering 30% of the front and back surface, stating: "This product contains nicotine which is a highly addictive substance."
- Information Requirements: Labels must include information about the product's ingredients, nicotine content, and instructions for use and storage.
3. Advertising and Promotion:
- Restrictions: Advertising of e-cigarettes and e-liquids is heavily restricted. Cross-border advertising (e.g., on TV, radio, and online) is banned, similar to the rules for traditional tobacco products.
4. Product Notifications and Reporting:
- Notification: Manufacturers and importers must notify their products to the relevant authorities six months before they intend to place them on the market. The notification must include details about the product's ingredients, emissions, and nicotine dose consistency.
- Reporting Requirements: Manufacturers and importers must submit annual reports to the authorities with sales volumes, consumer preferences, and trends.
5. Monitoring and Compliance:
- Market Surveillance: Member states are required to conduct market surveillance to ensure compliance with TPD regulations.
- Harmful Effects Reporting: Manufacturers must report any suspected adverse effects to the authorities.
6. Cross-Border Sales:
- Online Sales: Cross-border distance sales (online sales) must comply with the TPD rules, and retailers need to register with their member state authorities.
7. Product Standards and Quality Control:
- Manufacturing Practices: Products must be manufactured in a way that ensures consistent quality and safety.
- Testing and Emissions: Emissions testing for harmful chemicals is required to ensure products meet safety standards.
8. Information to Consumers:
- Consumer Information Leaflets: Packaging must include leaflets with information on the potential adverse effects, addictiveness, and toxicity of the product.
These rules aim to ensure a high level of health protection for consumers and to reduce the appeal of vaping products to young people. Each EU member state is responsible for implementing and enforcing these regulations, so there may be some variations in how they are applied locally.