The government has launched the free-to-use Trader Support Service which will help businesses and traders prepare for the changes that will affect your business if you move goods into and out of Northern Ireland. If you have already placed an individual product on the EU, EEA or the UK market (either in Northern Ireland or Great Britain) before 1 January 2021, you do not need to do anything.
The Northern Ireland Protocol came into force on 1 January 2021. For as long as it is in force, Northern Ireland will align with relevant EU rules relating to the placing on the market of manufactured goods. What you need to do depends on the type of goods you are placing on the market. This page covers goods often known as new approach goods, which are a range of consumer and commercial products that often require the use of the CE marking to demonstrate conformity with the relevant technical requirements.
The UK government’s interpretation of the requirements for labelling e-liquids for Northern Ireland is necessary for clarification. Several queries have been raised with the Department of Health and MHRA, concerning the labelling provisions of the Tobacco Products Directive (TPD) and how these should be applied to bottles of e-liquid. Given the limited space available on packs and that the text of the Directive is open to interpretation, please find below clarification on the UK Government’s interpretation of the requirements. Please ensure you read the accompanying notes.
TPD Article 20(4)(b) requires certain information to appear on the ‘unit packets’ and any ‘outside packaging’ of electronic cigarettes and refill containers. The UK implementing regulations transpose the definitions of ‘unit packet’ and ‘outside packaging’ as:
a “unit pack”, in relation to a tobacco product or related product, means the smallest individual packaging in which that product is, or is intended to be, presented for retail sale (regardless of whether it is presented inside a container pack), but does not include any transparent wrapper.
a “container pack”, in relation to a tobacco product or related product means any packaging—
- in which that product is, or is intended to be, presented for retail sale; and
- which contains (whether fully or partially enclosing)—
- a unit pack of that product, or
- an aggregation of such unit packs,
and where there is more than one separate layer of such packaging, each layer is to be regarded as a separate container pack, but a transparent wrapper alone is not a container pack. The principle that underpins the legislation is that the consumer receives the required information before purchasing. To aid understanding a number of scenarios are explored below:
Bottle of e-liquid with no further packaging other than an information leaflet attached to the bottle via tag or other means. The labelling requirements must be applied to the bottle, via label, pull-out label or other means.
Bottle of e-liquid and information leaflet placed within a cardboard box/sleeve The cardboard box/sleeve is considered the smallest individual packaging. TPD labelling must be applied to the cardboard box/sleeve. The bottle does not have to carry this information. Producers will wish to include information on the bottle to identify the product and ensure it can be used safely.
Multipack of 2 or more bottles of e-liquid or e-liquid included in a presentation box or starter kit
If the individual bottles are placed in a cardboard box/sleeve (as in point 2) TPD labelling must be applied to both the individual cardboard box/sleeve and each subsequent layer of packaging (container pack). Where the individual bottles not packaged and are aggregated in a multipack or presentation box, the multipack or presentation box would be considered the unit pack. In this scenario only the multipack or presentation box would require TPD labelling. Producers will wish to include information on the bottle to identify the product and ensure it can be used safely.
When applying the health warning producers must adhere to the provisions on format and positioning in TPD Articles 9(4) and 12(2). This guidance only relates to the TPD labelling requirements and no other statutory requirements such as European Regulation (EC) No 1272/2008 on classification, labelling and packaging of chemical substances (CLP). All the above examples apply equally to other forms of nicotine refill containers such as nicotine-containing cartridges.
The MHRA is the competent authority for a notification scheme for e-cigarettes and refill containers in Great Britain and Northern Ireland and is responsible for implementing the majority of provisions under Part 6 of the Tobacco and Related Products Regulations 2016 (TRPR), as amended.
The TRPR introduced rules which ensure:
- minimum standards for the safety and quality of all e-cigarettes and refill containers (otherwise known as e-liquids)
- that information is provided to consumers so that they can make informed choices
- an environment that protects children from starting to use these products.
The requirements:
- restrict e-cigarette tanks to a capacity of no more than 2ml
- restrict the maximum volume of nicotine-containing e-liquid for sale in one refill container to 10ml
- restrict e-liquids to a nicotine strength of no more than 20mg/ml
- require nicotine-containing products or their packaging to be child-resistant and tamper evident
- ban certain ingredients including colourings, caffeine and taurine
- include new labelling requirements and warnings
- require all e-cigarettes and e-liquids be notified and published by the MHRA before they can be sold
The 2020 regulations amend the Tobacco Products and Nicotine Inhaling Products (Amendment etc) (EU Exit) Regulations 2019 to implement the obligations of the Withdrawal Agreement and the Northern Ireland Protocol in law. This amends the way in which the Tobacco and Related Products Regulations 2016 apply in Great Britain and Northern Ireland.
The 2020 Regulations sets out the requirements for new products to be notified from 1 January 2021. This will mean that:
- Producers placing products on the Northern Ireland market will be required to notify using the EU Common Entry Gate (EU-CEG) system for the notification of tobacco and e-cigarette products.
- Producers placing products on the Great Britain market will be required to notify on the Great Britain domestic system.
- Notifiers will be required to pay one fee if they notify in relation to placing products on one of the Great Britain or Northern Ireland markets and the same one fee if they notify in relation to placing products on the two markets.
A producer is anyone who manufactures or imports these products or who re-brands any product as their own. Retailers do not need to submit information for any products they sell unless they also qualify as a producer. The Tobacco and Related Products Regulations 2016 do not cover nicotine-containing products that are authorised as medicines.
