Eight key points for manufacturers and importers – EU directive 2014/40/EU

Manufacturers and importers must notify their products to Member State competent authorities -Article 20(2). This notification must include below information:

  1. Ingredients and emissions

  2. Toxicological data

    • Additives that increase addictiveness and toxicity should be prohibited

    • Additives that have CMR properties in unburnt form, should be prohibited

  3. Information on nicotine doses and uptake

  4. Description of the device and production processes

  5. Sales data and information on consumer preferences annually to Member States (Article 20(7))

  6. Collect information on suspected adverse effects on human health and take immediate corrective action if they believe their products to be unsafe (Article 20(9))

  7. TPD sets limits on the amount of nicotine in consumer e-cigarettes and refill containers. E-liquids must not contain more than 20 mg/ml nicotine (Article 20(3)(b)), tanks and cartridges must not be larger than 2 ml, and refill containers must not be larger than 10 ml (Article 20(3)(a))

  8. Refill containers and e-cigarettes must also be child-resistant and tamper-proof and sold with instructions for use and health warnings (Article 20 paragraphs 3(g), 4(a) and (b))

 

Click on link below for EU directive 2014/40/EU

http://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32014L0040