Consultation outcome

Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2018

Updated 21 February 2019

Purpose

We seek feedback on the practical changes that will affect the tobacco and e-cigarette industries if the UK leaves the EU with no deal. We welcome feedback on any practical issues that you think should be considered as part of the implementation of changes.

Context

Current regulations for tobacco and related products are designed to promote and protect the public’s health. The government’s priority is to maintain the same high standards after the UK leaves the EU.

We firmly believe it is in the interests of both the EU and UK to strike a deal. That remains the goal on both sides and we are confident that this will be achieved. Nevertheless, we recognise the need to have clear plans in place for no deal.

In the event of no deal, the UK government is introducing legislation to ensure that the policies and systems in place to regulate tobacco products and e-cigarettes will continue to function effectively and maintain continuity with current arrangements where possible. This approach means that there will be minimal disruption for citizens and businesses in relation to tobacco products and e-cigarettes.

What would happen in a March 2019 ‘no deal’ scenario?

If the UK leaves the EU in March 2019 with no agreement in place, the Tobacco Products Directive and the Tobacco Advertising Directive would no longer directly apply to the UK.

The UK domestic law that implements these directives, such as the Tobacco and Related Products Regulations 2016, would remain in force, with minor amendments to ensure it still works effectively after EU exit. These amendments would be brought in through regulations made under the EU (Withdrawal) Act 2018 powers and would come into force on exit day.

The amendments to UK tobacco legislation would include giving the UK government the power to update the legislation in response to emerging threats, changing safety and quality standards, and technological advances. These updating powers are likely to have minimal impact on industry. Their purpose is to make sure that the UK is still able to make technical changes after we leave the EU, where needed.

Implications for industry

This document sets out government plans for:

• a new domestic system to allow producers to notify e-cigarettes in accordance with existing rules (part 1)
• a new domestic system to allow producers to notify tobacco products in accordance with existing rules (part 2)
• the introduction of new picture warnings for tobacco products, based on the picture library owned by the Australian government (part 3)

Further guidance

Following this consultation, the government, the Medicines and Healthcare products Regulatory Agency (MHRA) and Public Health England (PHE) will issue further guidance in relation to the changes to notification processes and the picture warnings by January 2019. We welcome feedback from you to ensure that this guidance sets out clear expectations in relation to implementation of these changes.

Part 1: notification processes for e-cigarettes

In the event of no deal, the MHRA will accept data from the industry in the same XML format as is currently submitted to the EU Common Entry Gateway (EU-CEG). For an overview of the current process please see the MHRA guidance.

The government will continue to recognise submitter IDs issued by the European Commission including those issued after the UK exits the EU.

Notifiers should, wherever possible, continue to use the same product ID number for UK notifications as has been used to notify that product to the EU.

Products that have been notified to the UK prior to the UK leaving the EU will not require re-notification.

Changes to current procedure

Wherever a product is being sold in the UK, the government is asking notifiers to upload the notification files to a secure government server. This is in addition to any requirements made by the Tobacco Products Directive (TPD) for notification in the EU. All notifiers will need to register with the UK portal to submit their data.

If a notifier does not wish to submit non-UK market information (points 32 to 46 listed in TPD submission data dictionary – electronic cigarettes v1.1.1) to the UK, then they should remove that data before submitting to the MHRA.

If notifiers are unwilling or unable to send us information in the form set out above, then we will require them to complete an online form including all relevant data points, excluding points 32 to 46, listed in TPD submission data dictionary – electronic cigarettes. This will also allow any required attachments to be submitted along with the form.

Notifiers will be required to provide details of a responsible UK party if this information is not currently provided via the EU-CEG.

Question

Can you inform us about any practical or technical issues that you think we should consider as part of the system that has been outlined above?

Part 2: notification processes for tobacco products

In the event of no deal, PHE will accept data from the industry in the same XML format as is currently submitted to the EU-CEG. For an overview of the current process please see the PHE guidance.

The government will continue to recognise submitter IDs issued by the European Commission including those issued after the UK exits the EU.

Notifiers should, wherever possible, continue to use the same product ID number for UK notifications as has been used to notify that product to the EU.

Products that have been notified to the UK prior to the UK leaving the EU will not require re-notification.

Changes to current procedure

Wherever a product is being sold in the UK, the government is asking notifiers to upload the notification files to a secure government server. This is in addition to any requirements made by the TPD for notification in the EU. All notifiers will need to register with the UK portal to submit their data.

If a notifier uploads information on non-UK markets to the UK server, then this data will not be visible in the active UK system, but for the purposes of integrity the original data submitted will remain on our database.

If a notifier does not wish this information to be uploaded to the UK server, then they should remove that data before submitting to the UK.

If manufacturers are unwilling or unable to send us information in the form set out above, then we will require them to complete an online form with all relevant data points, excluding points 38 to 56, listed in TPD submission data dictionary – tobacco products v1.1.1. This will also allow any required attachments to be submitted along with the form.

Question

Can you inform us about any practical or technical issues that you think we should consider as part of the system that has been outlined above?

Part 3: changes to picture warnings

In the event of no deal, the UK will need to introduce new picture warnings for tobacco products as the copyright for the existing picture library is owned by the European Commission.

Manufacturers will need to ensure that tobacco products produced from exit day onwards feature new picture warnings, which have been secured by agreement with the Australian government.

Tobacco products featuring pictures from the EU library, produced before exit day, may be sold for 12 months after exit day.

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

The government intends to publish further guidance in relation to cropping and sizing of the images to ensure that the Australian images can be easily adapted by the industry and will conform to existing legislative requirements in relation to image and pack size.

Australian pictures

The relevant pictures and text warnings that we will require manufacturers to use are included in the annex, below.

Questions

Can you inform us about any practical or technical issues that you think we should consider as part of the the changes to picture warnings?

Can you provide any information in relation to cost associated with changing the picture library?

What further information would be helpful in terms of guidance to ensure that the transition to the new picture library is as smooth as possible?

Annex: picture library

Australian picture library 2004

Text: Smoking clogs your arteries

UK library picture number: 1

Australian library picture number: 4

© Commonwealth of Australia

Text: Don’t let children breathe your smoke

UK library picture number: 2

Australian library picture number: 5

© Commonwealth of Australia

Text: Smoking causes blindness

UK library picture number: 3

Australian library picture number: 9

© Commonwealth of Australia

Text: Smoking causes lung cancer

UK library picture number: 4

Australian library picture number: 10

© Commonwealth of Australia

Text: Smoking doubles your risk of stroke

UK library picture number: 5

Australian library picture number: 12

© Commonwealth of Australia

Text: Tobacco smoke is toxic

UK library picture number: 6

Australian library picture number: 14

© Commonwealth of Australia

Australian picture library 2011

Text: Smoking harms unborn babies

UK library picture number: 7

Australian library picture number: 1

© Commonwealth of Australia

Text: Smoking causes peripheral vascular disease

UK library picture number: 8

Australian library picture number: 5

© Commonwealth of Australia

Text: smoking causes emphysema

UK library picture number: 9

Australian library picture number: 6

© Commonwealth of Australia

Text: Quitting will improve your health

UK library picture number: 10

Australian library picture number: 7

© Commonwealth of Australia

Text: Smoking damages your gums and teeth

UK library picture number: 11

Australian library picture number: 8 (front)

© Commonwealth of Australia

Text: Smoking damages your gums and teeth

UK library picture number: 12

Australian library picture number: 8 (back)

© Commonwealth of Australia

Text: Smoking causes throat cancer

UK library picture number: 13

Australian library picture number: 9

© Commonwealth of Australia