Tobacco Products Directive (TPD)
The new law came into effect on 20th May, 2016, with huge implications for the eCigarette industry. Are you ready? Our team at EL-Science can help you be fully TPD compliant by the compliance deadline of 20th November, 2016.
With our unique solution based approach we will ensure you meet the highest TPD standards whilst maintaining your eLiquid flavour profile.
ON 20TH MAY 2016, A NEW LAW CAME INTO EFFECT WITH HUGE IMPLICATIONS FOR THE ECIGARETTE INDUSTRY.
WE CAN HELP YOU UNDERSTAND WHAT THIS MEANS FOR YOU, AND WE CAN HELP YOU GET READY BY THE COMPLIANCE DEADLINE OF 20TH NOVEMBER 2016.
What is the TPD?
In 2014, the European Commission added electronic cigarettes into the Tobacco Products Directive and gave them their own article (Article 20) within the document which effectively classified them as a tobacco product.
This article outlines the requirements which must be met in order to manufacture and retail electronic cigarettes, refills, and associated accessories. The TPD is being written into law by the UK government and came into effect on 20th May 2016 with a compliance deadline of 20th November 2016.
How To Become TPD Compliant
Why EL-Science?
The primary difference between EL Science services and those of others offering TPD services is that we are specialist eLiquid scientists with our own eLiquid Analytical Laboratories and Flavour Laboratories on site.
We not only analyse the eLiquid but we provide the toxicological thresholds to work to and very importantly and uniquely, we then work with you to achieve those thresholds should your initial flavour not meet them. We enable you to meet the thresholds whilst maintaining your flavour profile through our Flavour Laboratory.
The primary requirements of the TPD Article 20 are summarised below:
- Manufacturers and importers must submit a technical dossier to the relevant authorities (the MHRA in the UK) for each product.
- A nicotine-containing liquid will have a maximum strength of 20 mg/mL.
- Additives are highly restricted.
- Refill bottles are limited to 10 mL, and pre-filled refill tanks and cartridges are limited to 2 mL.
- Advertising is heavily restricted.
- There are some restrictions on cross-border sales.
- Retailers and manufacturers are required to share market data and trends with the competent authority.
- Where sufficient robust data becomes available, member states may effectively ban individual products.
EL-Science Assistance with TPD Implementation
As specialists in the legislative and technical aspects required to meet the Tobacco Products Directive, we are able to assist with all aspects of TPD implementation from initial discussion and providing some clarity to the requirements through to providing a full technical dossier.
Technical Dossier
The TPD requires a Technical Dossier for every eLiquid flavour to be submitted to the Medical Health Regulatory Authority (MHRA) no later than November 2016.
A key requirement of this dossier is a full Toxicological Risk Assessment (TRA) for that eLiquid flavour. Our team can compile and produce this TPD compliant Technical Dossier for your business.
Our services comprise of:
- Analytical services
- Compilation of toxicological data sets
- Toxicological Risk Assessments
- Final Technical Dossier compilation and submission
While the TPD requirements appear relatively straightforward and easy to meet, the primary concern stems from this requirement, and it is here that investment is primarily required. This Technical Dossier must:
- Contain administrative information such as addresses, descriptions and declarations.
- Detail the full chemical composition.
- Provide a complete set of toxicological data for each chemical component.
- Have an associated Toxicological Risk Assessment (TRA) prepared using the accumulated data for each end product.
eLiquids will undergo a full Toxicological Risk Assessment:
Stage One – Toxicological Determination
We work with specialist, fully registered toxicological companies to determine the toxicological profiles of over 300 individual chemical components, selected because they form the base components of the vast majority of flavour concentrates. Each chemical is individually assessed for potential adverse effects, and components of concern will be further investigated to achieve effective threshold limits.
Stage Two – Compositional Determination
The chemical composition of an eLiquid must be determined through a combination of supplier information and analytical determination and confirmation. Our dedicated eLiquid laboratory where we house high specification GCMS, Thermal Desorption, Atomic Absorption equipment and a whole range of smaller laboratory instrumentation which has been specifically chosen and commissioned to allow for chemical compositional analysis of eLiquid and eLiquid vapour.
Stage Three – Thermal Degradation Profiling
While no direct combustion occurs during the usage of ecigarettes, the atomiser coil may elevate temperatures to above 300 degrees celsius. At such high temperatures, certain chemicals can degrade. Thus, it is important to investigate these potential degradation pathways. This investigation work is then confirmed by GC/MS Thermal Desorption technology within our Analytical Laboratories.
Stage Four – Toxicological Risk Assessment
Where appropriate, utilising the data generated in the previous stages, our Toxicological partners then perform a full TPD compliant Toxicological Risk Assessment (TRA) for the specific eLiquid flavour for inclusion in your Technical Dossier.
Stage Five – Compilation and Submission
Our team of organic chemists are dedicated to understanding the toxicological data sets, thermal profiles and analyses for each eLiquid flavour. They ensure that each Technical Dossier is correctly compiled and compliant with submission requirements. Only when the team is fully satisfied that the Technical Dossier contains all the required data do they submit the notification on your behalf, directly to the MHRA.