Global Forum on Nicotine - ejuicelab
Global Forum on Nicotine 2016
October 1, 2016

Understanding TPD Legislation for Vape Products in 9 Simple Steps

eJuice Lab TPD

By Cuts Ice Ltd

Our mission at Cuts Ice is to produce the purest and most appealing e-liquid for our consumers. This is driven by an excellent understanding of what makes e-liquid special, years of improving processes and developing new industry specific methodology for testing regimes. Cuts Ice is BSI ISO 9001/2008 and 14001/2015 accredited, demonstrating excellent product quality, traceability and environmental management.

1. PRODUCTION

The European Tobacco Products Directive (Directive 2014/40/EU, aka TPD) and the United Kingdom equivalent – The Tobacco and Related Products Regulation 2016 (TRPR) – will be enforced on the 20th May 2016. These legislative texts impose requirements on the way e-liquids and other vape products that contain nicotine are manufactured. As a responsible and ethical independent e-liquid manufacturer, we have already in place many of these requirements, however, we are very advanced in our testing regime and are ready to notify when the system become live.

2. SUPPLY OF RAW MATERIALS

Our upstream supply chain is almost entirely from the United Kingdom (UK), giving us confidence in the quality of our product.

– Nicotine, Propylene Glycol (PG) and Vegetable Glycerine (VG) (USP/EP grade)
– Flavourings are all ‘food grade’
– Caps are child resistant certified (ISO 8317:2016) and have also a tamper evidence system in place. They have been leak and drip tested to comply with the TPD*.
– Bottles and tips are specifically for Cuts Ice in the UK.
3. E-LIQUID ANALYSIS

Quality and understanding of our products is paramount. All liquids are sent for analysis to a UK Governmental enforcement body, Trading Standards ISO17025 accredited laboratory to ensure there are no Molecules Of Concern (MOC) in the formulation. They are also tested to ensure there are no additives prohibited by the TPD.

4. EMISSIONS TESTING

Cuts Ice work very closely with ISO17025 accredited and government approved laboratories that have methods developed for the testing of the e-liquid emissions. These methods are designed to detect not only nicotine, but also carbonyls (e.g. formaldehyde), metals, Volatile Organic Compounds (VOCs), Tobacco-specific nitrosamines (TSNAs) and other analytes of interest. They can also determine the nicotine dose and uptake of the e-liquid with selected ‘hardware’.

5. TOXICOLOGICAL ASSESSMENTS

Our team of two toxicologists carefully examine the ingredients in the complex ‘pre-mix’ e-liquid final flavours and produce detailed Toxicological Monographs (TMs) per ingredient. In addition, when analytes are detected in any of the emissions, our toxicology team will prepare Health Critical Value (HCV) summaries on these MOCs to determine if there could be any potential adverse effects to both the consumer, and non-consumer.

6. LABELLING AND PACKAGING

Our manufacturing facility has two fully automated lines that fill, tip, cap, torque, label, box and finally insert an information booklet, ending up in a fully TPD compliant product.

*Our Bottles, or refill containers have a securely attached nozzle of just over 9 mm long and a flow control mechanism that emits less than 20 drops of refill liquid per minute when placed vertically, making our refill containers are compliant with the Commission Implementing Decision (EU) 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes.

7. NOTIFICATION (EU-CEG)

The European Commission has designed a notification scheme to report the products in the vape industry. This scheme is described in the Commission Implementing Decision (EU) 2015/2183 of 24 November 2015 establishing a common format for the notification of electronic cigarettes and refill containers.

The Electronic Cigarettes etc. (Fees) Regulations 2016 establishes the fees that are necessary to pay to submit a notification to the MHRA, the competent authority in the UK. The fee is payable by the person submitting the notification at the time the notification is submitted.

? Notification fee: £150
? Substantially modified products fee: £80
? Annual fee: £60 (this fee will be charged each year on the first occurring 1st April after the day the product is notified).
8. SHIPPING WITH DECLARATION OF CONFORMITY

Another part of compliance is to declare that products conform to the production process described in legislation, including the quality and safety of ingredients. Every product we make after 20 November 2016 will be sent with documentation to reassure it is compliant and has been notified.

9. WHAT DO YOU NEED TO DO?

OEM client

If you would like Cuts Ice to produce e-liquids for your brand and steward your products through the TPD, we need you to create an ECAS account here and then apply for a Submitter ID here. After which, call our sales department and set up a meeting to discuss your requirements. Tel: 0208 960 6974, option 3.

Wholesaler

As a producer, Cuts Ice can only manufacture and supply you with e-liquids that are non-compliant with TPD until the 19th of November 2016. After that date, the only liquids that we will make will be fully compliant and notified TPD products.

Retailers

Relax and continue to sell our products. Only producers and importers have to report ‘vape’ products to MHRA via the EU-CEG portal, so you do not need to do any filing with the authorities. Your only responsibility is to confirm that all the products you sell after 20th November 2016 have been notified (we will supply a declaration of conformity with all of our products), and implement an age verification system on your websites.

eJuice Lab TPD compliance diagram