Tobacco Products Directive (TPD) 2014/14/EU
What is the Tobacco Product Directive (TPD)?
In May 2016, the revised EU Tobacco Products Directives 2014/14/EU (TPD) came into force, with big implications for those in the vaping industry.
The TPD sets out the rules for the manufacture and sale of tobacco products, with the aim of protecting consumer health. The UK has adopted the TPD into law, detailed in the Tobacco and Related Products Regulations 2016 (TRPR). It is the responsibility of the brand owner to submit product notifications to the relevant authority, which can be a complex and time consuming process in order to meet the rules set out for e-cigarette specifications.
With our full TPD Notification service, we can register eliquids & devices in the UK and Europe on your behalf.
In our state-of-the-art facility, our experienced R&D team can also amend formulations on your behalf, to ensure your submission is successful and safe. What’s the best part? We offer a price guarantee – we guarantee to beat the price of any other service, keeping your outgoings as low as possible.
What is the TPD notification process?
Step One
E-Liquid Pre-Assessment
Firstly, we will start by obtaining as much detail about an E-liquid as possible, in order to provide you with a quote based on the complexity of your submission. This includes a basic overview of your E-liquid and the countries you want your E-liquid to be registered in.
Step Two
Product Risk Assessment
In step two, we obtain all details from yourself and your suppliers. This includes formulations, details of the materials used and the manufacturing process, down to the hazard classifications of each component. A product risk assessment is then undertaken.
Step Three
Laboratory Analysis
The product is sent to the lab for laboratory analysis, where tests such as emissions testing and content testing are undertaken. Testing is completed to confirm that all of the claimed ingredients are in fact in the product, and to confirm that the emissions are as expected.
Step Four
Toxicological Risk Assessment & Review
Using specialist toxicological data, we prepare written toxicological profiles for each individual eliquid component. Each chemical component is assessed against TPD specified parameters relating to toxicity in order to determine any potential side effects. Components that do not meet TPD requirements will be further investigated and amended to ensure TPD compliance.
The chemical composition of the eliquid is determined using a range of information, from the materials used in the manufacturing process and the manufacturing process itself to analytical data. Using analytical equipment such as GC-MS, Thermal Desorption, ICP-MS and UPLC, we are able to determine and confirm the composition of any eliquid.
When used, atomiser coils in e-cigarettes can reach temperatures of over 300 degrees Celsius. Whilst there is no direct combustion taking place, at such high temperatures chemicals can degrade, altering the nature and potential toxicity of the e-liquid. Therefore, it is a requirement to investigate the degradation potential of the eliquid, using analytical equipment such as GC-MS.
Using the data generated from the previous stages, our chemical experts perform a TPD compliant toxicological risk assessment (TRA) for each eliquid to submit in your technical dossier. This involves comparing, analysing and evaluating all of the acquired data against Health Criteria Values (HCVs) – established limits at which an ingredient can be present in an e-liquid without being harmful to health.
In the final stage of the Toxicological Risk Assessment (TRA), our team of chemists review all of the data acquired throughout the entire TPD submission process to ensure the eliquid meets TPD specifications. Once compliant, the technical dossier is compiled in the correct format, and submitted directly to the MHRA on your behalf.
Step Five
Technical Dossier Review & Compilation
Once we have completed laboratory testing and a toxicological risk assessment (TRA), the data obtained is reviewed to ensure TPD compliance and a successful submission. The data is then compiled in the correct TPD format.
Step Six
Notification Submission
In the final stage, once an E-liquid has passed been reviewed and a technical dossier prepared, the notification is submitted by us on your behalf.
How else can we help?
We offer all services to enable you to get your e-liquid from an initial concept to market
Formulations
Our expert scientists turn your innovative concepts into industry-leading products.
Lab Analysis
We implement rigorous analysis every step of the way to ensure trust and safety.
Toxicological Review
Our chemists are able to provide toxicological risk assessments (TRA) for any e-liquid.
Notifications
Our compliance experts can navigate the complex process of registering an e-liquid.
Labelling & MSDS
Our experts use the latest legislation to provide you the most up-to-date consultation.
What services do we offer?
We offer all services to enable you to get your eliquid from initial concept to market
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TPD Compliant E-Liquid Formulations
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TPD Notification Service
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TPD Risk Assessments
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TPD Toxicological Risk Assessments (TRAs)
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TPD Emissions Testing
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TPD Product & E-Liquid Component MSDS
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E-Liquid Laboratory Analysis
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E-liquid CLP & Packaging
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Supplement Formulations
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Supplement Lab Testing
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Supplement MSDS
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Supplement CLP & Packaging
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Access to Retail Package
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Eliquid CLP, Packaging & Labelling
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CBD FSA Packaging & Labelling
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Supplement Packaging & Labelling
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Consultation on how to achieve HACCP certification
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Tailored support throughout the certification process
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Consultation on how to manage the HACCP system
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Labelling & packaging consultation
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Creation and/or validation of formulations
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Creation and/or validation of MSDS
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Access to a range of highly regarded certification authorities
Pricing
At Simple Compliance, we try to make things as simple as possible. That is why our prices are displayed upfront, cutting out the initial back and forth. Please enquire with out team to answer any questions you may have regarding our services or prices, who will be more than happy to discuss how we can help you simplify your compliance.
E-Liquid TPD Notifications
| 1 Submission | £685 |
| 3 Submissions | £645 |
| 10 Submissions | £595 |
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* Introductory offer: up to 50% off your first notification |
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SDS
| 1 SDS | £90 |
| 3 SDS | £80 |
| 5 SDS | £70 |
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* Introductory offer: Commit to 5 SDS, get one free |
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CLP
| 1 CLP Check | £40 |
| 3 CLP Checks | £35 |
| 5 CLP Checks | £30 |
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* Introductory offer: Commit to 5 CLP checks, get one free |
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Formulations
| Dependent on your requirements, the number of hours required for a formulation development will vary. Please enquire with our team to get a custom quote. | |
| Standard rate | £180 /hour |
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| * Commit to 10 hours of development and get 1 hour free * Discounted rates on CLP & SDS: Formulation, CLP and MSDS package |
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Why work with us?
- Simple for the client and by-extension consumer
- Cheaper than competitors: Price guarantee, significantly reduce costs
- No hassle or stress, we handle everything
- Years of experience in the vape and food industry
- Team of experienced chemists and formulation scientists