Changes to requirements for tobacco products including novel products and herbal products for smoking and e-cigarettes from 1 January 2021

This guidance provides information on how requirements for picture warnings on certain tobacco products, and the notification of e-cigarettes, tobacco products including novel products and herbal products for smoking will change after the end of the transition period, as a result of the Northern Ireland Protocol. This guidance is relevant to organisations, businesses and members of the public concerned with tobacco and related products.

Changes to regulations from 1 January 2021

On 31 January 2020 the UK left the European Union under the terms set out in the European Union (Withdrawal Agreement) Act 2020 (EUWA). The UK is in the transition period that will last until 31 December 2020, and the government is taking the necessary measures to implement the changes to correct any remaining deficiencies arising from withdrawal which would otherwise remain at the end of this period.

The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 have now been made. The regulations amend the Tobacco Products and Nicotine Inhaling Products (Amendment etc) (EU Exit) Regulations 2019 (2019 Regulations) to implement the obligations of the Northern Ireland Protocol in law. This means further amendments to the way in which the Tobacco and Related Products Regulations 2016 apply in Great Britain (GB) and Northern Ireland (NI) after the end of the transition period.

Labelling relevant tobacco products with picture warnings from 1 January 2021

Great Britain

Manufacturers must ensure relevant tobacco products placed on the GB market from 1 January 2021 feature one of the text warnings with the corresponding colour photograph, listed in the picture library in Schedule A1 to the Tobacco and Related Products Regulations 2016 as amended by the 2019 Regulations.

There will be one set of pictures from 1 January 2021 and no rotations between sets, as is currently the case (the EU picture library features 3 sets of 14 pictures, rotated on an annual basis).

Northern Ireland

The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 amend the provision in the 2019 Regulations to reflect the fact that manufacturers placing products on the market in NI must continue to comply with the EU’s Tobacco Products Directive (TPD) requirements from the end of the transition period. This includes continued use of the EU picture warnings.

For tobacco products being placed on the market in NI, manufacturers will need to ensure that products continue to feature the EU picture library images in line with the TPD requirements.

There are 3 sets of pictures which are rotated on an annual basis starting on 20 May and ending on 19 May. The TPD picture guidance provides more detail on the process.

Manufacturers supplying products from NI to GB will need to ensure these products adhere to GB requirements, featuring the picture warnings listed in the picture library in Schedule A1 to the Tobacco and Related Products Regulations 2016 as amended by the 2019 Regulations.

The Department of Health and Social Care (DHSC) has circulated guidance in relation to the cropping and sizing of warning images for both sets of pictures. The guidance is available on the DHSC Exchange platform. Please contact Healthy.Behaviours@dhsc.gov.uk if you do not have access to DHSC Exchange.

Sell-through period for products featuring EU pictures on the GB market after 1 January 2021

The Withdrawal Agreement allows the continued supply of tobacco products that were lawfully placed on the market in the UK before the end of the transition period.

Through the Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020, regulation 9 of the 2019 Regulations has been amended to remove the 12-month sell-through deadline. The new regulation allows products featuring the EU pictures that were produced and first supplied on the UK market before 1 January 2021 to remain on the market until they reach their end-user.

Notifying e-cigarettes from 1 January 2021

Great Britain

For new products supplied in GB from 1 January 2021, producers will be required to notify through a GB portal to the Medicines Healthcare products Regulatory Agency (MHRA). The MHRA will accept data in the same XML format as is currently submitted to the EU Common Entry Gate (EU-CEG), or via an online form.

Northern Ireland

The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 amend the provision in the 2019 Regulations to reflect the fact that products to be placed on the NI market will continue to be notified to the UK in line with the TPD.

In order to place an e-cigarette on the market in NI, the government requires notifiers to continue to upload the notification files through the EU-CEG.

For specific guidance on notifying an e-cigarette to the MHRA for GB and NI please see Placing an e-cigarette on the market from 1 January 2021.

Notifying tobacco and herbal products for smoking from 1 January 2021

Great Britain

For new products to be sold in GB from 1 January 2021, producers must notify through the GB Domestic Tobacco Products Notification System to Public Health England (PHE). PHE will accept data from the industry in the same XML format as is currently submitted to the EU-CEG.

Northern Ireland

The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 amend the provision in the 2019 Regulations to reflect that products to be placed on the NI market will continue to be notified in the UK in line with the TPD.

In order to place a tobacco product and herbal product for smoking on the market in NI, the Government requires notifiers to continue to upload the notification files to the EU-CEG.

For specific guidance on notifying tobacco or herbal products to PHE for GB and NI from 1 January 2021 see Notification of tobacco or herbal products for smoking.

Track and trace

The track and trace and security marking provisions of the TPD do not form part of this notice. HMRC leads on these measures and are engaging with stakeholders separately.

Guidance

The government has issued guidance in relation to the changes to notification processes for e-cigarettes. Guidance on how to notify tobacco and herbal products will be available shortly.

Guidance on the cropping requirements for the pictures that are to be used for tobacco products which are placed on the market in GB have been circulated and uploaded onto DHSC Exchange

The current regulations

Current regulations for tobacco and related products are designed to promote and protect the public’s health. We will maintain these standards after the end of the transition period.

Some of the UK law which regulates tobacco products and e-cigarettes currently implements EU legislation, such as the TPD and Tobacco Advertising Directive.

EU legislation on tobacco and related products covers:

• control of the sale of products
• advertising
• product standards (such as ingredients of products and their emissions)
• packaging

The TPD also sets reporting requirements for tobacco products and e-cigarettes. This means manufacturers must submit information on ingredients and emissions for products before they are placed on the market.

The Tobacco Products and Nicotine Inhaling Products (Amendment etc) (EU Exit) Regulations 2019 made changes to the way in which tobacco control legislation worked in the UK. The regulations included the following changes:

• amending or omitting EU/EEA/member state references
• revoking EU obligations and reciprocal arrangements that will no longer be relevant to the UK
• transferring relevant commission powers under the TPD to the Secretary of State
• allowing for the establishment of new notification systems for tobacco products and e-cigarettes
• allowing for the use of Australian picture warnings to replace the ones which are owned by the commission
• introducing a fee-making power

Information on the changes in The Tobacco Products and Nicotine Inhaling Products (Amendment etc) (EU Exit) Regulations 2019

Further information

• The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020
• The Tobacco Products and Nicotine Inhaling Products (Amendment etc) (EU Exit) Regulations 2019
• EU Tobacco Products Directive 2014
• Revised Northern Ireland Protocol
• European Commission notice to stakeholders – withdrawal of the United Kingdom and EU rules on tobacco and related products
• The UK’s approach to the Northern Ireland Protocol