By now it’s expected that most manufacturers of e-liquid will have complied with the new regulations, but as The Medicines and Healthcare Products Regulatory Agency has provided some clarification and interpretation of the regulations, it’s worth a quick sanity check to make sure that as a manufacturer, you are complying with the new labelling regulations.
Why are the new labelling guidelines so important?
The new TPD regulations are aimed at ensuring minimum standards across the industry for both safety and quality of e-cigarettes and e-liquids and to help consumers make informed choices about the products they purchase.
The full range of new requirements includes a number of specific product changes, including new rules that e-liquid products cannot now be sold in bottles of more than 10ml, or with a strength greater than 20mg/ml (2.0%).
These new product sizing regulations present a number of challenges to manufacturers, and have led to different interpretations of what is and what is not specifically required as well as what exactly what the labelling requirements actually are (see later).
What are the new labelling requirements?
Specific labelling requirements for e-liquids sold in the UK must carry the following individual elements somewhere on the packaging
- Health warning
Under the new labelling requirements, the words: ‘This product contains nicotine which is a highly addictive substance’ must be included on the boxing/packaging as well as on the label of the 10ml bottle itself (unless the e-liquid’s nicotine content is zero).
Labelling should carry an indication of the nicotine content per dose.
All ingredients of the e-liquid where they are used in quantities of 0.1% or more of the final formulation must be listed, including (specifically) the nicotine content. Flavouring information should also be provided.
- Directions for use
Usage information should include advice on safe usage, suitability for filling of e-cigarettes and information on storage and disposal of the container and its contents.
Other information that must be present on label and packaging include age restriction, expiry date for shelf life, batch details for traceability and declaration that the manufacturer/importer bears responsibility for the quality and safety of the product under normal or reasonably foreseeable conditions.
Definition of labelling
The TPD Regulations legislation states that the required information must be provided to the consumer before purchasing, clearly and legibly, and that “the labelling requirements must be applied to the bottle, via label, pull-out label or other means”.
This wording, particularly the use of “other means”, has led to a number of possible interpretations of what ‘labelling’ requirements actually are. So recognising that a number of different packaging possibilities exist, the Medicines and Healthcare Products Regulatory Agency provides the following interpretations:
1) Bottle of e-liquid
Where e-liquid is sold in a 10ml bottle 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.
2) Bottle of e-liquid and information leaflet placed within a cardboard box/sleeve
In this case, the cardboard box/sleeve is considered the smallest individual packaging, so the warning information must be applied to the cardboard box/sleeve and a patient information leaflet needs to be included. The bottle does not have to carry all of the information.
3) Multipack of 2 or more bottles of e-liquid or e-liquid included in a presentation box or starter kit
A range of possibilities exist. Best to consult your e-liquid labelling provider!
Who do the regulations apply to?
The regulations apply to ‘producers’ of e-liquids, defined as people or organisations which manufacture or import e-liquid products, along with people or organisations who re-brand them as their own.
Still need advice or information about e-liquid labelling and packaging? Call us at Readability on 01440 712273 or email firstname.lastname@example.org to discuss all your e-liquid label, stickers and carton requirements.