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 accordance with the regulations must not supply that product for sale in the UK.

Public Health England (PHE), sponsored by the Department of Health and Social Care, is the UK’s competent authority for the management and publication of 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 Tobacco and Related Products Regulations 2016, who plan to supply a tobacco or herbal product for consumption in the UK or through the travel retail sector.

Timescales for notification

The timescales for notification are as follows.

Tobacco products

At least one day before the producer first supplies the product.

Novel tobacco products

At least 6 months before the producer intends to first supply the product.

Herbal products for smoking

At least one day before the producer first supplies the product.

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. A single notification fee is charged per 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

These 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 (TNCO)

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.

The amount of the annual fee payable is £1,000, except where the number of samples of the variant which the Secretary of State has required in the fee period is 5 or less. In such cases, the amount of the annual fee payable is £167 multiplied by the number of samples which the Secretary of State has required in the fee period.

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

Submissions that do not attract fees

There are no fees for submissions that do not constitute either a notification or a modification. For example, when a submission is made to correct information made 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. These are set out below.

Cigarettes, hand rolling tobacco, or a novel tobacco product

Cigars, cigarillos, and chewing, nasal, waterpipe and pipe tobacco products

Herbal products for smoking

Payment method and schedule

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

PHE 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 fees regulations or this guidance, contact tobacco.notifications@phe.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 the Great Britain (England, Wales and Scotland) market.

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, as long as a Northern Ireland business provides the following information to UK authorities:

• pre-market notification: for new tobacco and related products being brought to the Great Britain market for the first time, they should provide the same information provided to EU regulators
• 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

Until the end of the UK`s transition period from the EU (31 December 2020), businesses must continue to make notifications of tobacco and herbal products for smoking to be sold in the UK via the European Union Common Entry Gate (EU-CEG) notification portal.

From 1 January 2021, manufacturers and importers of tobacco and herbal products for smoking (notifiers) will still be required by law to notify these products for sale in Great Britain. They should notify PHE directly, as the competent authority for these products. Products intended for sale in Northern Ireland should continue to be notified to the EU-CEG.

This guidance sets out the new arrangements that will apply from 1 January 2021, most notably that:

• the notification process for tobacco and herbal related products will be different for Great Britain and Northern Ireland
• notifications for Great Britain will cover the countries of England, Scotland and Wales
• notifications for Northern Ireland will only cover Northern Ireland

Overview

To ensure that notifiers can continue to fulfil the requirements of UK regulations, PHE has created its own domestic tobacco products notification system for the submission of data to Great Britain.

Notifiers of tobacco and herbal products to the Great Britain market will need to use this new system from 1 January 2021. Notifiers of tobacco and related products to be sold in Northern Ireland should continue to make submissions to the EU-CEG.

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

To minimise additional burden to notifiers, the Great Britain system will accept data in the same formats as currently submitted to the EU-CEG.

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. If the product remains notified to either the EU-CEG for Northern Ireland or to the Great Britain domestic notification system on 1 March each year, it will only incur one annual fee for that product.

If you are notifying the same product to both the Great Britain and Northern Ireland markets, you should notify both systems (the EU-CEG and Great Britain domestic notification system) at the same time.

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

PHE will ensure that it retains all current compliant notifications for the UK market that have been submitted to EU-CEG before 1 January 2021.

Manufacturers and importers will not be required to resubmit this data, including attachments previously uploaded. The notifications and attachments will all be transferred to the new Great Britain domestic notification system before 1 January 2021. The EU will retain any notifications to the UK market from before 1 January 2021 and reassign them to Northern Ireland.

To support the transfer of notifications from the EU-CEG to the Great Britain domestic notification system, manufacturers and importers are requested not to make any new submissions for UK products to the EU-CEG from 1 minute past midnight on 21 December 2020. Notifications to PHE for Great Britain products should start from 1 January 2021.

To help with this transition, it is preferred that no notifications are made to the UK market on the EU-CEG between 21 December 2020 and 31 December 2020. However, if this is not possible, PHE will be able to download these from the EU-CEG system later in January 2021.

Using System-to-System and ETrustEx data submission systems

When submitting notification data to the Great Britain domestic notification system, you should continue to use your existing system to create data for submission.

System-to-System

If you use System-to-System, you should continue to generate data in the same way as you currently do. You can then submit by the secure transmission of data method detailed below, called Egress Switch.

ETrustEx

If you use the ETrustEx standalone system, you should continue to use the XML Creator tool to create XML files which you should send to the Great Britain domestic notification system using Egress Switch. Further details about this are below.

Whichever way you choose to create your data, products to be notified to the Great Britain market should be notified to the Great Britain domestic notification system from 1 January 2021, and products to be notified to the Northern Ireland market should be notified to the EU-CEG at any time.

Guidance to new notifiers to Great Britain and Northern Ireland after 1 January 2021

Businesses that do not already have a submitter ID allocated by the EU-CEG system, and which intend to notify products to either the Great Britain or Northern Ireland market after 1 January 2021, will require a unique submitter ID.

This ID should be obtained from the European Commission if you intend to notify products to Northern Ireland or any EU member state now or in the future.

PHE will also recognise EU-CEG assigned ID numbers within the Great Britain domestic notification system, to help with cross referencing of the 2 systems.

If you only ever intend to notify products to the Great Britain market, you may choose to apply for a Great Britain specific ID from PHE. The steps below provide information on how to access an ID number from the EU:

1. Create an EU Login account on the EU-CEG website following the step by step process
2. Download the registration form available at the EU commission Submitter ID page
3. Complete the form using the instructions provided
4. Send the form or email, 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 once the form is received
6. Users will need to register to use the freely available 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 this EU login page
7. Ensure you follow the data dictionary business rules for the submission of tobacco data, available from the Commission`s implementing decision guidance on the format and submission of tobacco products
8. Once you have your submitter ID, you have 2 options for how you submit product information to the Great Britain domestic notification system, as follows

If you only intend to notify products to the Great Britain market, you can choose to apply for a Great Britain specific ID from PHE instead. To apply for a unique submitter ID for the Great Britain market only, please contact PHE at tobacco.notifications@phe.gov.uk

Once you have your submitter ID, you have 2 options for submitting product information to the Great Britain domestic notification system, as follows.

Submitting data using Microsoft ETrustEx

Once you have added the product data and the attachment data into the XML Creation Tool, you are ready to use the ETrustEx export function to submit these to the Great Britain domestic notification system using Egress Switch.

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’, to be uploaded and sent to PHE using Egress Switch.

The email subject heading for these XML files to be sent to Great Britain should be your unique submitter ID, month and year.

Egress Switch for the secure transmission of data to PHE

Before 1 January 2021, PHE will send an encrypted email to current notifiers that have previously notified compliant products for sale on the UK market. Any new notifiers to the Great Britain market after 1 January, should contact PHE at tobacco.notifications@phe.gov.uk

The email will contain instructions on how you can create a secure encrypted email, to which all data files can be attached.

When you attach the files and send the email to PHE at tobacco.submissions@phe.gov.uk you will receive an automatic email to acknowledge that we have received it. We will then upload this data to the Great Britain domestic notification system.

Please note that attachments larger than 50MB cannot be sent by Egress Switch. If your file size is larger than this, it should be separated into multiple, smaller files and sent using more than one secure email submission.

If you experience any issues with the Great Britain domestic notification system, email PHE the details along with a copy of the error report and a screenshot (if available) at tobacco.notifications@phe.gov.uk

Any other questions about the UK competent authority function or relevant regulations should also be sent to tobacco.notifications@phe.gov.uk

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

For more general assistance with submissions to the EU-CEG, including seeking 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 santeeu-ceg@ec.europa.eu