The Tobacco Products Directive 2014/14/EU (TPD) Article 20 came into force on 20 May 2016 and introduces new rules for electronic nicotine delivery systems and refill containers, including:
- Minimum standards for the safety and quality of all e-cigarettes and refill containers (otherwise known as e-liquids)
- That information will be provided to consumers so that they can make informed choices
- An environment that protects children from starting to use these products
The new requirements include:
- Restrict e-cigarette tanks to a capacity of no more than 2ml
- Restrict the maximum volume of 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 to be notified to the Medicines and Healthcare products Regulatory Authority (MHRA) before they can be sold
What it means for producers
Under the TPD, it is the responsibility of the producer to ensure that their products comply with the TPD requirements, with producers of new e-cigarettes and refill container products required to submit a notification to the MHRA six months before they intend to put their product on the market.
Producers must also inform the 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.
What it means for retailers
Until 19 May 2017, retailers can continue to sell products that are already in stock. When sourcing new suppliers of any e-cigarette or refill container products, retailers must ask the supplier whether the product complies with the TPD requirements. If the answer is no, the product(s) may only be sold until 19 May 2017.
On 20 May 2017, retailers will need to remove any stock from sale that is not compliant with the TPD.
From 20 May 2017, when sourcing new suppliers of any e-cigarette or e-liquid product, retailers must check that the details of the notification for the product have been published in the list of Submitted Products. If the producer has not notified the product or it does not comply with the TPD, producers must not supply that product to retailers.
Retailers do not need to notify the MHRA of any products, unless they are also a producer of the product.
Learn about TPD Article 20 at ENDS this June
Understanding how the new rules affect your business moving forward and what you need to do to ensure compliance is just one of the topics covered at Smithers Rapra’s ENDS conference from 14-15 June 2017. Beryl Keeley, E-cigarette Notification Scheme Lead at the MHRA, will be presenting the opening keynote on ‘Implementing TPD2 for e-cigarettes and where we have got to’. The presentation will provide a detailed insight into what TPD2 means for producers.
In addition to the presentations on the TPD2 regulations, the ENDS conference will also focus on testing standards and methods for ENDS components and e-liquids, testing materials and labels, advertising practices for e-cigarettes, potential tobacco harm reduction, ongoing safety assessment obligations, future product design and development and more. This in-depth overview of the ENDS industry will allow attendees to gain insight into how to ensure their products are safe.
Why you should attend
We’ve developed a programme that includes leading industry players from every level of the supply chain to ensure an informative and balanced agenda. What makes this conference unique is that it provides a truly comprehensive overview of the ENDS market.
Representatives from the MHRA, British American Tobacco, ECITA, UKVIA (UK Vaping Industry Association), Eliquid Solutions, Leadscope, British Standards Institute, Space Jam Juice, Nicopure Labs, Altria and more will present on a range of hot topics and take part in panel discussions.
Presentations and panel discussions include:
- Common mistakes in e-cig research
- Developing standards for electronic cigarettes for the UK, Ireland and beyond
- Analysis of liquids and hardware, PMT and TPD regulations
- Repeat dose inhalation testing for ENDS premarket tobacco product applications
- Best practices for extractables and leachables testing of ENDS
- Tobacco harm reduction and negativity towards e-cigarettes
Who should attend
Anyone who works with electronic nicotine delivery systems, whether for a CRO, end-user, instrument manufacturer, distributor, researcher or retailer, will gain something from attending this conference.
Already confirmed to attend this June includes representatives from Philip Morris International, Japan Tobacco International, Battelle Memorial Institute, Butterworth Laboratories, Molins, Cambridge Design Partnership, Labstat International and more so can you afford to miss it?
Tickets are currently just £999 for a 2-day conference ticket as part of the Spring Sale, but this price will rise to £1,099 after Friday 5 May so book before then to avoid paying more for your ticket.
Book your ticket
For more information about TPD Article 20, please visit https://www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-products