The Tobacco Products Directive 2014/14/EU (TPD) introduces new rules for nicotine-containing electronic cigarettes and refill containers (Article 20). MHRA is responsible for implementing the majority of provisions under Article 20 and has been designated as the competent authority for the notification scheme for e-cigarettes and refill containers in the UK.
The TPD introduces new rules which ensure:
- minimum standards for the safety and quality of all e-cigarettes and refill containers (otherwise known as e-liquids)
- that information will be provided to consumers so that they can make informed choices
- an environment that protects children from starting to use these products.
The UK Tobacco and Related Products Regulations 2016 implement the TPD in the UK, and came into force on 20 May 2016. Part 6 of the regulations sets out the requirements for e-cigarettes and refill containers.
The regulations introduce requirements for producers of e-cigarettes and refill containers. A producer is anyone who manufactures or imports these products or who re-brands any product as their own. Producers must submit information about their products to MHRA through a European Common Entry Gate (EU-CEG) notification portal.
When MHRA is satisfied that a product notification is complete and complies with the TPD, we will publish all non-confidential information. Producers will be able to specify information that they consider to be confidential when they submit a notification.
Retailers do not need to submit information for any products they sell unless they also qualify as a producer. Retailers have until 20 May 2017 to sell through stock of products that do not comply with the labelling and product composition requirements of the TPD.
Nicotine Base Liquid
The TPD requirements on nicotine concentration (20mg/ml maximum) and size of presentation (10ml maximum for refill container and 2ml maximum for e-cigarettes) apply to products sold to end consumers (irrespective of whether the end consumer intends to modify the product).
The requirements do not apply to ‘trade sales’ i.e. where you are selling industrial quantities to another business and the sale is not directed to a consumer. But for all sales (trade and to consumers) the tank capacity of a refillable e-cigarette must not exceed 2ml.
The application of all TPD requirements are subject to transitional provisions.