Emissions from electronic cigarettes: Northern Ireland
Updated 16 August 2024
Applies to Northern Ireland
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Introduction
Article 20(2) of Directive 2014/40/EU [TPD] places an obligation on the manufacturers and importers of electronic cigarettes to submit a notification to the competent authorities of the member states of such products they intend to market.
Article 20(2)(b) of the Tobacco Products Directive (TPD) requires the notification to include a list of the emissions which result from the use of the product.
The European Commission has established a common format for the notification of these products 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 emissions and the information required are set out in section 5 of the annex.
Requirements
The TPD requires emissions from all notified products to be included in the submission. The testing should be carried out in accordance with the expected use of the product and the usage instructions as provided in the product’s user leaflet, or by a standardised puff regime once available (you should then refer to this standard in the submission).
A list of key emissions which we expect to be reported for any notified product is set out in the table below. This list is not exhaustive and other emissions may also need to be included in the notification.
Key emissions to report
Under section 5 on emissions, you should always submit information on the following key emissions.
| Compound | CAS number |
|---|---|
| Acetaldehyde | 75-07-0 |
| Acrolein | 107-02-8 |
| Formaldehyde | 50-00-0 |
Depending on the particular device/liquid combination and the toxicological assessment, may need to provide information on other key emissions. These include diethylene glycol, ethylene glycol, diacetyl, pentane 2,3 dione and tobacco-specific nitrosamines.
Depending on the material composition of the hardware, you should provide information on the following metal emissions.
| Metal | CAS number |
|---|---|
| Aluminium | 7429-90-5 |
| Chromium | 7440-47-3 |
| Iron | 7439-89-6 |
| Nickel | 7440-02-0 |
| Tin | 7440-31-5 |
If other metals such as lead and mercury are present in the hardware, you should include information on these.
Carrying out testing
Hardware
Where a product is to be placed on the market as a single e-cigarette unit sold together in one combination, this should be tested and notified 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 clear justification as to why these are also applicable for the current notification.
Where products are supplied separately, companies should endeavour to test devices, refill containers and cartridges that they wish to notify in combination with other product(s) from their own portfolio. Where this is not possible (because the company does not supply all components to the market) you should carry out testing with the product that you estimate 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 for the additional product. If not known, you should provide the brand name and member states in which the product is available. If external power supplies are used, 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 include emissions data in the notification for each of the items or combinations. However, it may not be necessary to test all combinations. You should test the combination expected to produce the maximum emissions (without prejudice to the section on flavours below). You can use the results obtained to support combinations which are likely to produce a lesser level of emissions, but you should clearly justify the appropriateness of the data submitted.
Similarly (without prejudice to the section on flavours below) a range of product options will not always require testing of each variant. You may rely on data generated from a representative sample and justify your choice. Where a combination could justifiably be expected to have the same emissions as a tested combination, you should submit the results for the combination tested, together with a clear justification as to why the results are applicable.
Where a product includes a modular device with the ability to vary the power level in use, you should normally carry out testing at the highest level at which the device can operate optimally and report data for that level only. You should clearly justify the power level tested.
Flavours
You should carry out emissions testing at least once on each flavour and on each combination of flavours. It may not be necessary to test all flavours or combinations of flavours with all kits or devices. You may be able to rely on data generated on a subset of flavour or product options on a risk-based basis. Provided the flavour or flavour combination has been tested in one presentation, you could use the data generated to support other notifications, provided the emissions can justifiably be expected to be similar. You should provide clear justification for the choice of subset.
What to report
The annex to the Commission Implementing Decision sets out the data you should report in the notification.
Where multiple emissions have been measured, you must complete the following information for each of them:
- the name of the emission
- the quantity produced during use, based on the measurement method used
- a description of the test method used, including reference to a recognised approved standard, when available
You must report one of the following for each emission identified:
-
the Chemical Abstracts Service number (CAS) of the compound (where one exists)
-
the International Union of Pure and Applied Chemistry (IUPAC) name, if a CAS number does not exist
For all submissions, you should include the test methods used in the submission or refer to a recognised standard test method, once available. In the absence of standard methodology, the description of the test methodology should contain information capable of enabling the regulator to understand and be in a position to duplicate the emission test if necessary.