Tobacco Products Directive
E-cigarette Regulations explained
What producers need to do before their product can go on the market
TPD Compliance and MHRA Notification
In May 2016, new rules for nicotine-containing electronic cigarettes and refill containers (Article 20) were introduced, these are known as the ‘Tobacco Products Directive’ (TPD).
There is a notification scheme for e-cigarettes and refill containers in the UK, managed by the Medicines and Healthcare products Regulatory Agency ( MHRA ), the competent authority responsible for implementing the majority of provisions under Article 20. Producers of new e-cigarette and refill container products must submit a notification to MHRA six months before they intend to put their product on the UK market. A substantially modified product must be treated as a new product and follow the notification submission process before it can be sold.
The TPD rules are in place
minimum standards for the safety and quality of all electronic cigarettes (e-cigarettes) and refill containers (eliquids or 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 new requirements (applicable from 20 May 2017) cover manufacture, presentation and sale of tobacco related products.
Producers are required
e-cigarette tanks to a capacity of no more than 2 ml
the maximum volume of nicotine-containing e-liquid for sale in one refill container to 10 ml
e-liquids to a nicotine strength of no more than 20 mg/ml
TO MAKE EVIDENT:
packaging of nicotine-containing products is child-resistant and tamper-evident
products do not contain any banned ingredients – including colourings, caffeine and taurine
labelling requirements and warnings are included
notification to MHRA has been submitted before an e-cigarette product is put on sale in the UK
Nicotine-containing products that are authorised as medicines are not covered by the TPD.
Submitted e-cigarette products
Products which have been notified to MHRA appear on the Submitted Products and Withdrawn UK Notifications lists. These lists can be referred to by retailers, consumers and Trading Standards bodies to enable them to verify the companies and brands of e-cigarettes and refill containers (e-liquids) that have been notified to MHRA or withdrawn from sale in the UK.
Under the TPD
The Producer must take full responsibility to ensure their products comply with the TPD requirements
Each Notification submitted to MHRA is checked with the producers for:
completeness and TPD compliance
A review is carried out and the TPD compliance status of the product is:
declared compliant by the producer
recorded as ‘declared’, completing the notification process
After Notification process has been completed, the producer can withdraw products from sale. This may be for any number of reasons, including commercial changes, superseded products and compliance or safety issues.
Advice for Producers, Importers, Manufacturers and Distributers
E-cigarette producers must inform MHRA if they have reason to believe that a notifiable product is unsafe, not of good quality or not compliant with TPD regulations and provide details of the risk to human health and safety and any corrective action taken.
Trading Standards bodies have enforcement responsibilities under the legislation and MHRA works with them to ensure acceptable standards of safety.
Restriction of Hazardous Substances in Electrical and Electronic Equipment Regulation 2012 (RoHS)
E-cigarettes , as well as being TPD Compliant and having an MHRA Notification, also need to comply with the Restriction of Hazardous Substances in Electrical and Electronic Equipment Regulation 2012 (RoHS).
Manufacturers, Importers and Distributers are obligated
they limit the amount of certain hazardous substances in this type of electrical equipment
their product or model meets requirements and complies with the regulations
The regulation is enforced by the Office for Product Safety and Standards, part of the Department for Business, Energy and Industrial Strategy.
E-cigarette and Eliquid Labelling and Leaflets
The Tobacco Products Directive (TPD) requirements for labelling of e-cigarette and refill container products is set out in Regulation 37 of the Tobacco and Related Products Regulations 2016.
Eliquid Producers are required
TO LIST INGREDIENTS:
on the product container label where used in quantities of 0.1% or more of the final formulation of the Eliquid
in full in Notifications submitted to MHRA through the EU-CEG, ie the list should include all component chemicals
On Product Labels, it is acceptable to describe the flavouring ingredient by giving it a flavour name, for example ‘strawberry flavour’ instead of listing several component chemicals.
Companies may choose to describe individual ingredients used in quantities below 0.1% of the final formulation by a category, eg ‘other flavourings’ for confidentiality reasons.
E-Cigarette advice on safe usage is required
INFORMATION ON THE PACK OR LEAFLET INSERT:
to provide the user with information about safe use of the product
to include appropriate advice on product storage
to include instructions to ensure there is no battery malfunction
If all of the required information for the leaflet will fit on the packaging and labelling without any loss of legibility, then the ‘pack’ does not need to contain a separate leaflet insert.
Additional statutory labelling requirements may also apply, such as the European Regulation (EC) No 1272/2008 on classification, labelling and packaging of chemical substances (CLP).
Quality Systems & Laboratory Testing Experience
The team at IFS Laboratories have the combined laboratory testing experience and highly specialised knowledge of Operational/Quality Management to help producers to manage their production. Tests are carried out in our fully equipped lab using the latest equipment. We are dedicated to delivering the highest quality of customer service, with a sense of warmth, friendliness, individual pride.
Tobacco Products Directive (TPD) Compliance
IFS Laboratories fully support the regulation of e-cigarettes. We have the expertise and testing capability to provide producers with the services they need to ensure their products meet the required government standards for quality and safety. Whatever the future of e-cigarettes is, the team at IFS share the same vision, to work with producers to improve the safety of their vaping products and minimise adverse side-effects.
Commitment to Safeguarding Public Health
IFS Laboratories is passionate about providing independent testing of electronic cigarettes to safeguard public health. Studies show that quitting smoking is one of the best things you can do for your health and properly regulated e-cigarettes can be used effectively as a life-saving strategy for smokers trying to quit. Healthcare experts think e–cigarettes could help eradicate smoking-related diseases.