Guidance

Notification of tobacco products and herbal products for sale in the UK

Updated 1 November 2023

About this guidance

Since 20 May 2016, businesses have been required to notify the UK government before making a tobacco or herbal product for smoking available for sale to the UK domestic market or travel retail sector.

Notification is a requirement under parts 4 and 5 of The Tobacco and Related Products Regulations 2016 (TRPR).

Businesses that fail to notify a product in line with the regulations must not supply that product for sale in the UK.

The Office for Health Improvement and Disparities (OHID) is the UK’s competent authority for managing and publishing notifications for tobacco products and herbal products for smoking.

Who this guidance is for

The guidance is for producers, manufacturers or importers of tobacco products and herbal products for smoking, as described by the TRPR. These businesses plan to supply a tobacco or herbal product for consumption in the UK or through the travel retail sector.

To ensure that notifiers can continue to fulfil the requirements of UK regulations, OHID has created its own domestic tobacco products notification system for the submission of data to Great Britain (England, Wales and Scotland). Notifiers of tobacco and herbal products to the Great Britain market need to use this system, which has been in place since 1 January 2021.

Notifiers of tobacco and related products to be sold in Northern Ireland should make submissions to the EU Common Entry Gate (EU-CEG).

OHID will continue to access the EU-CEG and manage the submissions made to Northern Ireland as the competent authority for the UK.

Timescales for notification

The timescales for notification are as follows.

Tobacco products

Tobacco products should be notified at least one day before the producer first supplies the product.

Novel tobacco products

Novel tobacco products should be notified at least 6 months before the producer intends to first supply the product.

The TRPR defines a novel tobacco product as:

“a tobacco product which—

(a) is not a cigarette, hand rolling tobacco, pipe tobacco, waterpipe tobacco, a cigar, a cigarillo, chewing tobacco, nasal tobacco or tobacco for oral use; and

(b) is first supplied by the producer after 19th May 2014.”

Herbal products for smoking

Herbal products for smoking should be notified at least one day before the producer first supplies the product.

The TRPR defines a herbal product for smoking as a:

“product based on plants, herbs or fruits which contains no tobacco and that can be consumed via a combustion process”.

Fees

The Tobacco Products and Herbal Products for Smoking (Fees) Regulations 2017 specify the various fees associated with notifying products.

Types of fees

There are 4 fee types.

Notification fees

Notification fees are payable for all products notified on or after 6 April 2017, for sale in the UK for the first time. There is a single notification fee for each product (a product with a unique tobacco product identification number, or TP-ID) where there is at least one product format notified for the UK market. The fee is payable on invoice and by the date specified.

Modification fees

Modification fees are payable when information is submitted for modifications of a product that has been previously notified.

For a tobacco or novel tobacco product, these are changes to the:

• ingredients information, as specified in regulation 19 of the TRPR
• emissions information, as specified in regulation 20 of the TRPR

For herbal products for smoking, these are changes to ingredients of the product or the quantity of each ingredient as specified in regulation 29 of the TRPR.

The fee is payable on invoice and by the date specified.

Annual reporting fees

Annual reporting fees are payable each year for all products still notified for the UK market on 1 March in that financial year. Where products have been removed from the UK market during the year, both the notification of withdrawal date and the withdrawal date must fall before 1 March to avoid triggering a fee for that year.

Any product where one or more formats under the same TP-ID have not been withdrawn from the UK market will continue to attract an annual reporting fee.

Annual fees for the testing of tar, nicotine and carbon monoxide

An annual fee is payable for the testing of samples of each variant of a brand of cigarettes as required by the Secretary of State in accordance with regulation 14 of the TRPR. This is testing for tar, nicotine and carbon monoxide (TNCO) yields.

The annual fee payable is £1,000 for one brand of cigarette variant that is tested in all 6 testing periods. Where a brand of cigarette is tested in 5 periods or less, the testing fee is £167 for each test. For example, testing 5 samples of the same cigarette variant in one year would cost £835.

The annual testing fee is due on 1 March each year.

Submissions that do not attract fees

There are no fees for submissions that do not constitute either a new notification or a modification. For example, when a submission is made to correct information in a previous notification or to notify the withdrawal of a product from the market.

Amounts payable

The fees for notifications and modifications as well as annual fees depend on the type of product.

The product types as defined in the tobacco data dictionary are as follows.

1. Cigarette
2. Cigar
3. Cigarillo
4. Roll your own tobacco
5. Pipe tobacco
6. Waterpipe tobacco
7. Oral tobacco
8. Nasal tobacco
9. Chewing tobacco
10. Herbal product for smoking
11. Novel tobacco product
12. Other (product placed on the market before 19 May 2014, not covered by categories 1 to 9)

Cigarettes, hand rolling tobacco or a novel tobacco product

Fee type	Amount
Notification fee	£200
Modification fee	£100
Annual reporting fee	£100
Annual testing fee (cigarettes only)	£1,000 or £167 multiplied by the number of samples required in the period if there were fewer than 5

Cigars, cigarillos, and chewing, nasal, waterpipe, pipe and other tobacco products (products placed on the market before 19 May 2014, not covered by categories 1 to 9)

Fee type	Amount
Notification fee	£100
Modification fee	£50
Annual reporting fee	£50

Herbal products for smoking

Fee type	Amount
Notification fee	£60
Modification fee	£30
Annual reporting fee	£30

Application of fees from 1 January 2021

If you are notifying the same product to the Great Britain and Northern Ireland markets, then that product will incur one new notification fee (you will not be charged twice). You should notify both systems (the EU-CEG and Great Britain domestic notification system) at the same time.

If the product is not withdrawn from either Northern Ireland or Great Britain on 1 March each year, it will incur an annual reporting fee.

Payment method and schedule

Companies need to complete and submit an invoicing information form for fees payable.

OHID will invoice companies directly and all fees are payable on invoice and by the date specified.

For copies of the invoicing information form and for any questions about the fee regulations or this guidance, contact tobacco.notifications@dhsc.gov.uk.

Unfettered access

The government is committed to ensuring unfettered access for products from Northern Ireland to the rest of the UK, through the appropriate legislation. The notification requirements do not impose any pre-market checks or approvals, or different legislative requirements for goods moving from the Northern Ireland to Great Britain.

Tobacco and related products have been granted highly regulated goods status. However, for qualifying Northern Ireland tobacco and herbal products, the UK will automatically accept tobacco products meeting EU requirements on the Great Britain market. This is as long as a Northern Ireland business provides information to UK authorities on:

1. Pre-market notification. For new tobacco and related products being brought to the Great Britain market for the first time, a business should provide the same information they gave to EU regulators.
2. Post-notified data. Market surveillance information sent to EU regulators (for example, if a safety risk is discovered after it has been placed on the market).

Instructions for making notifications to the UK

Arrangements since 1 January 2021

Since 1 January 2021, manufacturers and importers of tobacco, herbal and novel products for smoking have been required by law to notify OHID directly about products intended for sale in Great Britain. Products intended for sale in Northern Ireland should continue to be notified to the EU-CEG.

This guidance sets out the arrangements that have been in place since 1 January 2021, most notably that:

• the notification process for tobacco, herbal and novel products will be different for Great Britain and Northern Ireland
• data submissions to Great Britain can only be made using the XML creator tool version 1.3.1
• notifications to Northern Ireland should be made using the latest version of the XML creator tool as advised by the EU-CEG

Transferring notifications from EU-CEG to the Great Britain domestic tobacco notification system

OHID has retained all current compliant notifications for the UK market that were submitted to the EU-CEG before 1 January 2021. Businesses do not need to transfer product notifications to the Great Britain domestic tobacco notification system if they were already notified with the EU-CEG.

Using System-to-System and ETrustEx data submission systems

When submitting notification data to the Great Britain domestic notification system, you should use System-to-System or ETrustEx data submission systems.

System-to-System

If you use System-to-System, you can submit your data to the Great Britain domestic notification system using Microsoft (MS) Teams. You can find more information about using MS Teams to securely send data to OHID below.

ETrustEx

If you use the ETrustEx standalone system to create XML files, use the XML creator tool version 1.3.1. These files should also be sent to OHID using MS Teams to be uploaded into the Great Britain domestic notification system once an account has been created for your business. You can find more information about using MS Teams to securely send your data to OHID below.

Guidance to new notifiers to Great Britain and Northern Ireland

Notify products to the Great Britain market only

If your business only ever intends to notify products to the Great Britain market, you can apply for a Great Britain specific submitter ID from OHID. To apply for this unique submitter ID for the Great Britain market only, contact OHID at tobacco.notifications@dhsc.gov.uk.

Notify products to EU member states, Great Britain and Northern Ireland markets

Businesses that intend to notify products to EU member states, Great Britain and Northern Ireland markets will require a unique submitter ID from the European Commission. If you do not already have a submitter ID allocated by the European Commission, you will need to apply for one. You can find the steps on how to apply for a submitter ID from the European Commission below.

The Great Britain domestic notification system recognises EU-CEG assigned submitter ID numbers. This helps with cross-referencing of the 2 systems.

Applying for a submitter ID number from the European Commission

The steps on how to apply for a submitter ID number from the European Commission are as follows.

1. Create an EU Login account by following the EU-CEG step-by-step guide.
2. Download the registration form available in section 2 on how to register for a submitter ID at the EU-CEG step-by-step guide.
3. Complete the form using the instructions provided.
4. Email the form with the subject line of ‘Request for submitter ID – [insert your company’s registered name]’ to sante-subid-euceg@ec.europa.eu.
5. The European Commission will review and issue a submitter ID after they receive the form.
6. Install the Java 8 64-bit version on your computer to create downloadable XML files and attachments. You can find the appropriate version at Java downloads for all operating systems.
7. You will need to register to use the free ETrustEx XML creator tool to create and submit XML files to the Great Britain domestic notification system. The tpd-xml-creator-tool-1.3.1 and release notes are available from the CIRCABC library.

Submitting product information using Microsoft Teams and EtrustEx

MS Teams is a corporate tool used by OHID to work collaboratively with internal and external partners. MS Teams has been assessed, approved and accredited as a safe method for the secure transfer of commercially sensitive information and data.

New manufacturers and importers submitting to the UK will need to contact OHID at tobacco.notifications@dhsc.gov.uk to request information on how to make submissions to the UK.

Once you have returned the relevant forms, OHID will create a new team in MS Teams for your business and invite you to join. You will then be able to send OHID your product XML data files and supporting product documentation to be uploaded into the Great Britain domestic notification system.

Notifications to sell products in Northern Ireland should be made directly to the EU-CEG as described above.

If you experience any issues creating XML data files for Great Britain, email OHID the details of the issue along with a screenshot (if available) to tobacco.notifications@dhsc.gov.uk. If you are using the ETrustEx function, you will need to sort the data by date, then select the required Great Britain file in a subfolder of the ‘tpd-xml-creator-tool-1.3.1’ folder called ‘export’.

Once you have added the product data and the attachment into the XML creator tool, you are ready to use the ETrustEx export function to submit these to OHID. You should also send these to your MS Teams account and inform OHID by email about your submission.

Further help and advice

If you experience any issues with the EU-CEG system, you should email sante-euceg-itsupport@ec.europa.eu.

Questions about the UK competent authority function or relevant regulations should be sent to tobacco.notifications@dhsc.gov.uk.

For more general help with submissions to the EU-CEG, including applying for a submitter ID, you should contact sante-subid-euceg@ec.europa.eu.

For other general matters related to the functioning of the EU-CEG, contact sante-eu-ceg@ec.europa.eu.