Chapter 4 – dose of nicotine delivered and uptake and consistency of dose
Updated 16 August 2024
Applies to England, Scotland and Wales
© Crown copyright 2024
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/chapter-4-nicotine-dose-guidance-great-britain/dd34a6d3-1774-4751-9f1a-b3a7be08f50d
Introduction
The Tobacco and Related Products Regulations 2016 (TRPR) places an obligation on the manufacturers and importers of electronic cigarettes to submit a notification to the competent authority of such products they intend to market.
Regulation 31 (3)d of the TRPR requires the notification to include information on the nicotine dose and uptake when consumed under normal or reasonably foreseen conditions.
Regulation 36 (6) of the TRPR places an obligation on producers to ensure that the dose is delivered by an e-cigarette at a consistent level under normal conditions of use.
Great Britain will remain in alignment with the common format set out within Commission Implementing Decision 2015/2183 of 24 November 2015 establishing a common format for the notification of electronic cigarettes and refill containers. The submission format is set out in the annex to that Decision and the information required on nicotine dose and uptake is set out in section 6 of the annex.
Requirements
The TRPR requires those submitting to communicate the level of nicotine uptake when the product is used under normal and reasonably foreseeable conditions, and to describe the measurement methods used to assess this.
As full clinical testing will not be required, alternative methods to determine uptake, such as measurement of the weight of nicotine in the e-cigarette vapour, would be considered adequate.
The method used should be carried out in accordance with the expected use of the product and the usage instructions in the product’s user leaflet and a standard puff regime, A suitable standard would be BS ISO 20768:2018. In the absence of standard methodology, the description should contain information capable of enabling the regulator to understand and be in a position to duplicate the test, if necessary.
The TRPR also requires that those submitting notifications have determined the consistency of the dose delivered. You could measure and express this, for example, as nicotine content per puff (where the puff regime is accurately described) or per pack, as appropriate. The data reported should be determined over a set number of such puffs (for example, 10).
Carrying out testing
Where a product is to be placed on the market as a single e-cigarette unit sold together in one combination, you should test and notify it as a unit (the EC-ID will be reported with the notification).
Where the product is sold containing a range of strengths of nicotine-containing liquid, it may be sufficient to test the highest strength only. In these cases, you should submit the results for the liquid strength already tested, together with:
- a calculation of the expected dose delivery at the strength being notified
- a clear justification as to why the previous results are applicable
E-cigarettes
Where products are supplied separately, companies should endeavour to test devices and components that they wish to notify in combination with other product(s) from their own portfolio of products. Where this is not possible (because the company does not supply all components to the market) testing should take place with the product that the manufacturer/importer estimates to be most commonly used in combination with the product being notified or to pose the highest potential risk to the consumer.
Where known, you should state the EC-ID/GB-ID for the additional product. If not known, you should provide the brand name. If you use external power supplies, they should mimic the performance of the type of e-cigarette battery the product is designed to operate with.
Where a kit is marketed which contains more than one combination of items, you should usually test all combinations of the included items that could reasonably be expected to result in a different nicotine delivery, and submit the results separately under the relevant section of the notification. However, where a combination could reasonably be expected to have the same nicotine delivery as a tested combination, you should submit the results for the combination already tested together with a clear justification as to why these are also applicable for the current notification.
Where a product includes a modular device with the ability to vary the power level in use, you should normally test it at the highest level at which the device can operate optimally and report the data for that level only. You should be in a position to clearly justify the choice if requested.
E-liquids
Since the delivery of nicotine depends to a large extent on the device used, it may not be necessary to test all e-liquid products.
Unless the composition of the product suggests that the nicotine content may not be uniformly distributed throughout the liquid, the results of a sample flavour product from the range could be submitted for subsequent flavours, or a simple analysis of the nicotine content per ml of liquid will suffice. If there is a reasonable likelihood that the nicotine content is not uniformly distributed, then tests should take place as described in the sections above using a device that is likely to be commonly used with the e-liquid.