In our previous post, we introduced The Tobacco Products Directive (TPD) and the Tobacco and Related Products Regulations (TRPR), discussing the purpose of these regulations and the information required for a product notification. Here, we take a closer look at the testing required for Electronic Nicotine Delivery Systems (ENDS) and e-liquids, along with timelines and general costs.

What is TPD/TRPR?

If you’re considering taking a product to market in the UK and/or EU, you should be aware of TPD/TRPR. These regulations cover the requirements for the sale of e-cigarette products in the UK (TRPR) and Europe (TPD). Both regulations require testing to be carried out on vape products (such as e-liquids, pods and devices) before they can be sold, in order to ensure their safety and efficiency.

Required testing and costs

Testing ensures that all claims made on your product’s packaging are substantiated. This is carried out on the aerosol generated under normal use of the product. The testing requirements for TPD/TRPR are;

• Nicotine dose consistency, to ensure the product supplies a safe and steady delivery of nicotine to the user over the course of use. This is measured by the amount of nicotine delivered across different blocks of inhalations (a dose is typically taken to be 10 inhalations), and should be consistent with the amount stated on packaging. You can expect this testing to cost around £320-£750 per SKU if performed in a UK lab, with a turnaround time of 10 days upon receipt of samples.

• Carbonyl emissions testing, for e-cigarettes/e-liquids. Key emissions to be measured include formaldehyde, acetaldehyde and acrolein which can be hazardous to consumer health. You can expect carbonyl emission testing to cost around £220-£400 per SKU, with a turnaround time of 10 days upon receipt of samples.

• Metal emissions testing, for e-cigarettes/pods for metals in the aerosol. Metals may be given off from device components and inhaled by the user, causing possible health implications. The metals tested should therefore be representative of any of the products used in the construction of the hardware. The suite of metals to be tested depends on the device and the requirements of the customer, but would typically include; nickel, chromium, iron, tin, and aluminium. You can expect metal emissions testing to be around £280-£500 per SKU.

• Toxicology reports, which focus on CMR properties (carcinogenic, mutagenic and reproductive toxicity) as the Directive states that member states have the authority to prohibit ingredients that have CMR properties in unburnt form reaching the market. There is a range of other toxicology data including emission toxicity, addictive toxicity and others. The cost of toxicological reports usually start around £100 per compound and so they may present a significant cost. Some companies offer toxicological reports under licence included in the cost of their fees which can greatly reduce the cost of notification.

For e-liquids, testing may be carried out on the highest nicotine strength for each flavour requiring notification, as this data may then be used to support notifications for products of the same composition (e.g. the same propylene glycol/glycerol ratio and flavouring components) but differing nicotine strengths.

Inter Scientific can offer nicotine, carbonyl and metals testing to support TPD/TRPR notifications for e-liquids, pods and devices. Our aim is to make the TPD processes as cost-effective as possible for our clients and our team are continually developing ways to make the process more efficient to get you on the market quicker. For more information on our pricing and services, please contact us at: info@inter-scientific.com