Under the rules of the Tobacco Products Directive, eliquids and e-cigarettes are required to undergo emissions testing – also known as TPD testing – before they can be placed on the market.
TPD testing involves generating emissions from the e-cigarette or e-liquid and analysing for specific chemicals and metals at a specialist analytical laboratory under controlled conditions. It is a process that requires bespoke equipment and specially trained lab technicians.
The results of the test are submitted in a notification for assessment by the health authorities such as the MHRA.
Staff training on TPD notification and emissions testing at your site. Click here to learn more.
Article 2 b) of the Tobacco Product Directive reads as follows:
“A new notification shall be submitted for each substantial modification of the product. The notification shall, depending on whether the product is an electronic cigarette or a refill container, contain the following information:
(b) a list of all ingredients contained in, and emissions resulting from the use of, the product, by brand name and type, including quantities thereof;”
TPD requires manufacturers to test the emissions of e-cigarettes.
There are now a number of different types of companies in the UK and internationally offering an e-cigarette testing service. How do you know which one to choose?
There are a number of questions you should ask yourself when making your choice. They include:
We make sure any testing laboratory we use is truly independent and has no competing interests or associations with other e-cigarette companies. Medic Pro is also independent and has no competing interests – read more here.
E-cigarette testing is a specialist area and not all laboratories have the expertise (or equipment) to be able to offer the service. It is essential that the test is conducted by specialist technical staff that have the training, skills and experience in e-cigarette testing. The results should be expertly and accurately written up in a report as they may undergo scrutiny by the authorities at a later date.
The laboratories that conduct e-cigarette testing for our clients receive our full support for all regulatory matters. We address any questions the laboratory might have about the product being tested or agency questions on the design of the test. Note: all devices should not be tested the same way. The design of the test may differ between e-liquids and types of devices; a cig-a-like is tested under different conditions to RDAs, for example.
It is important to consider the e-cigarette testing fee at the laboratory (prices can range from £70 – £900 per e-liquid) and what emissions they test for. If the price is too low the test may not meet the minimum requirements; if the fee is too high they may be needlessly testing above and beyond the requirements.
We understand the minimum requirements and the likely cost of such a test. Any test we arrange with a laboratory is, at the very least, to the minimum requirements and at a sensible price.
We understand that many labs are offering TPD testing which goes beyond the TPD requirements. We ensure our clients test only in accordance with the requirements – we do not sell testing services unless it is required. Please contact us if you are not sure of the testing requirements.
TPD testing is one of the many services we offer to our clients. We have helped a variety of e-cigarette companies, from large manufacturers to small retailers/importers get products TPD tested for notification purposes (read a testimonial or case study).
We offer a personalised service which aims to ease the burden and cost of e-cigarette testing while ensuring the regulatory requirements are met.
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Complies with minimum TPD requirements and is accepted by EU Agencies (e.g., MHRA). We use an independent and accredited lab located in the UK with a turnaround in 10 days. Get a Quote
TPD testing to the highest quality Standards complies with ISO 20768 and is accepted by EU Agencies (e.g., MHRA). We use an independent and accredited lab located in the UK with a turnaround in 15 days. Get a Quote
ISO 20768 is the latest Standard to be published for vape products. According to the ISO website, the Standard defines and specifies:
“the requirements of machines used in laboratories to draw air through the devices in order to generate aerosol for subsequent analytical testing in a robust and reproducible manner.”
More specifically, the Standard:
Currently, vape products do not require testing according to any ISO Standards such as ISO 20768. But this will change. The TPD requires that when Standards become available vape products should comply with them. Agencies have not enforced this requirement but they will in the future.
Clients that use our services get complimentary regulatory phone support. We can answer your questions on various TPD-related topics such as TPD packaging, CLP and the impact of Brexit.
When we arrange testing on behalf of our clients, we only use selected labs that meet specific criteria, which include:
The TPD test report from the lab will include the emissions (name and quantity) and the test method used for submission in the notification. Some examples of the reported emissions include the aldehydes: acrolein, acetaldehyde, formaldehyde and metals: aluminium, chromium, cadmium, tin, and mercury. In addition, an indication of the nicotine dose consistency of the product is reported.
The method of the test that was used must also be submitted in the notification (the write-up of the method should contain enough information for the authorities to be able to replicate the test).
Our labs typically use the following equipment in the analysis:
We have a thorough knowledge of the TPD testing requirements and extensive e-cigarette testing experience. Should you require expert opinion on a service provider’s TPD testing please contact us.
An important part of our service is to keep testing costs down. We do not sell e-cigarette testing services unless it is necessary. We also work closely with our clients to minimise the impact on business of new and emerging regulations, which in turn, helps our clients to save money.
Complete the form below to request TPD testing or to speak to a TPD expert.
We are a London-based regulatory affairs consultancy providing services to the e-cigarette, cosmetic, biocide, pharmaceutical and medical device industry. We help e-cigarette companies comply with the Tobacco Products Directive and pharmaceutical companies obtain and maintain medical product licences. We also offer UKAS accredited biocide and analytical testing services.