The Tobacco Products Directive (TPD) (2014/40/EU) is the primary European Directive governing tobacco and related products, including e-cigarettes or Electronic Nicotine Delivery Systems (ENDS).

Since the exit of the United Kingdom from the European Union (EU), TPD no longer applies to England, Scotland, and Wales where the UK Tobacco and Related Products Regulations (TRPR) is now effective. TPD does however still apply to products sold in Northern Ireland.

What is the purpose of TPD/TRPR?

The purpose of TPD/TRPR is to safeguard public health by placing restrictions for the sale and marketing of tobacco and related products. In relation to ENDS, the restrictions are primarily concerned with:

• Concentration of nicotine in e-liquids
• Packaging
• Ingredients used in products

Though, this is not an extensive list of the restrictions.

What information is in a TPD/TRPR notification?

In accordance with the TPD, in order to sell ENDS within the EU manufacturers, distributors or importers must make a Notification to the European Commission 6 months prior to placing their product on the market. Contained in this notification are:

●     Data on the delivery of nicotine from the product

●     Emissions data following use of the product

●     Disclosure of Ingredients

●     Toxicological Reports on the Ingredients

●     Manufacturing overview

●     Manufacturer's declaration

●     Packaging

Notifications to the European Commission are submitted using the Commission's submitter tool, which then sends the notification to each concerned country through a centralised system. Each country is responsible however for the review (if appropriate) of the notification and a fee is charged by most countries in advance of allowing product sales.

Additional regulations to be aware of

Though TPD is the primary Directive regulating ENDS, other Regulations such as CLP are also effective, and manufacturers must now submit a Poisons Centre Notification (PCN) and label their products with a Unique Formulation Identifier (UFI) for products to be compliant for sale in Europe and Northern Ireland (this does not apply to products sold in England, Wales and Scotland).

For more information on TPD and TRPR or if you are looking for help with your product testing and notifications, including PCN and UFI, please contact us at: info@inter-scientific.com