TPD Compliant: What does it mean?

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What does it mean to be TPD compliant?

Alternatively, read about the: 9 Things you don’t need! (to be TPD compliant)

 

If you are a importer or manufacturer of e-cigarettes or e-liquids you need to get your products TPD compliant before you can sell in the EU. But what does it mean to be TPD compliant and how can we help you get your products TPD compliant?

The TPD – stands for Tobacco Products Directive – lays down the rules for the sale and marketing of e-cigarettes and e-liquids in the EU. It came into effect in May 2016. Any product must be fully compliant with the TPD before it is placed on the EU market.

 

 

The key rules of the TPD include:

 

1) Product Characteristics: New products must comply with product requirements such as size of bottle, tank size, child-resistant and tamper-evident packaging as well as refill mechanism technical regulations.

 

2) Notification: Information on the product characteristics, formulation/toxicology (e-liquids only) and emissions, among other things, are submitted to the MHRA via the EU-CEG portal prior to product launch.

 

3) Packaging and labelling: New rules apply to the packaging; health warning must appear on the label and certain warnings and precautions must appear in the leaflet, for example. Each member state has its own regulations (not only should the health warning be in the local language, but the health warning statement differs market to market – see Country-specific information).

 

4) Classification of Packaging and Labelling regulation (‘CLP’): Rules on the labelling of mixtures that pre-date the new e-cigarette regulations apply to e-liquids. These include the requirement of an exclamation mark or skull and bones pictograms, and precautionary statements.

 

tpd compliant

What are the CLP Regulations for e-liquids? Click here

 

5) Producer Registration: Companies must register with the authorities (where applicable) if they wish to sell direct to customers via the Internet.

 

How can we help you get TPD compliant?

 

1) Product Characteristics: We can conduct a full review of the products characteristics to check it is TPD compliant. We can inform you of the TPD rules (with background information) and help you understand if your product meets the child-resistant and tamper-evident packaging rules. We can review the refill mechanism and confirm it meets the technical requirements as laid down by the applicable legislation.

 

2) Notification: We can notify your products on your behalf or provide support so your company can make the notification.  We offer advice and guidance on the notification requirements such as toxicology (e-liquids only) and emissions testing, among other things, and help you to submit through the portal. We can arrange the emissions testing – also known as a ‘TPD test’ through a independent and specialist analytical laboratory.

 


Request a TPD Test


 

3) Packaging and labelling: We can provide country-specific information so your packaging complies with the rules in each Member State including the health warning and any other information that should appear in the leaflet. We can also advise on whether the health warning should appear on the outer carton or label or both which differs market to market.

 

4) Classification of Packaging and Labelling regulation (‘CLP’): We have been trained in the CLP regulation and can offer advise in this regard. We advise on the necessary warnings and precautionary statements that should appear on the pack and where the tactile warning should be presented (on the carton or on bottle itself).

 

5) Producer Registration: We provide the link to the documentation for you to complete. Should you have any questions in completing the form we will advise. Read more about registration below.

 

Please feel free to contact us for more information on how we can help.

Jump to:

Annual Sales Reporting Guidance

What are the penalties for non-compliance?

Do you need a licence to sell e-liquid?

What’s involved in TPD Registration?

 

How did the TPD come about?

 

The EU introduced the these new regulations as a revision to previous rules, which had been in place for over a decade and no longer reflected the latest scientific and market developments.

The revised TPD was designed to harmonise the regulation of tobacco and related products (including roll-your-own, cigars, e-cigarettes) across the EU. The new laws form part of wider tobacco policy aimed at reducing youth uptake of smoking and supporting smokers to quit. The implementation of the TPD was expected to have a positive effect on both.

 

What are the aims of the TPD?

 

The TPD aims to:

 

  • Update and harmonise legislation for the control of tobacco, and establish a regulatory framework for related products.
  • Reduce the prevalence of smoking by making sure tobacco products do not use ingredients or presentation that encourage young people to take up smoking.
  • Fight illicit trade by introducing an EU-wide tracking and tracing system for the legal supply chain and a security feature that combines both visible and invisible elements.
  • Establish a regulatory environment for e-cigarettes and e-liquids to ensure they meet safety and marketing standards.

 

Is the TPD a legal requirement?

 

Yes – with exceptions. E-liquids only need to comply with the rules of the TPD if they contain nicotine. For devices, the picture is a little more complicated. All devices fall within scope of the TPD, however, not all components of a device need to be notified. Components that are unique to e-cigarettes – such as tanks – should be notified but generic parts such as batteries (‘mods’) do not.

If you are unsure if your component falls within scope of TPD please contact us.

 

Are there any TPD loopholes?

 

Several TPD loopholes are being exploited. Two are discussed below:

 

1) An e-liquid only needs to comply with TPD rules if it contains nicotine: The TPD only applies to nicotine-containing e-liquids. To get around this rule some manufacturers have launched a range of ‘short-fills’ – also known as ‘shake and vape’.

Short-fills are nicotine-free refills typically sold in 100ml bottles that are under-filled by the manufacturer to allow room for the decanting of nicotine-containing e-liquid into the bottle after sale by the consumer. A consumer can purchase the short-fill together with a nicotine-only (no flavour) e-liquid – known as a ‘nic shot’ – and combine the two to make a nicotine e-liquid refill.

Because short-fills do not contain nicotine, the rules of the TPD do not apply so manufacturers can take advantage of the benefits of its non-TPD status – namely the restrictions on bottle size and notification requirements.

 

short-fill-tpd-loophole-ecig-Feb

Short-fills exploit a key TPD loophole

What do the health authorities say about short-fills?

 

Interpretations on the rules of the TPD differ among health authorities in the EU. When it comes to short-fills most agencies do not regulate short-fills under TPD rules but some do. The UK authority, the MHRA, have said at previous conferences that they will not regulate short fills because they do not contain nicotine and that manufactures should look to comply with General Products Directive for this product category.

 

2) Manufacturers selling a tube together with a TPD compliant tank: The TPD rule that restricts the size of tanks to 2ml has been sidestepped by some device manufacturers by including a tube in the kit, which can be assembled with other parts to form a tank larger than the 2ml tank provided. The fact the tube is not a tank means it does not need to comply to the TPD restriction on size.

 

What do the health authorities say about tubes?

 

Again, interpretations differ across Europe – some agencies will seek to close the tube TPD loophole in their country while others may not specifically address the issue. Agencies may challenge the manufacturers and importers on the issue and request an explanation as to how the product complies with the legislation. We can offer support in this regard.

 

 


To what extent did the UK transpose the rules of the TPD? Click here to find out 


Do you need a licence to sell e-liquid?

 

No but your business may need to be registered with an authority in the country in which you sell.

 

Who needs to register?

 

Registration rules differ market-to-market but typically if you sell nicotine-containing e-liquids online to other EU states you need to register (see Cross Border Distance Sales below).  In most markets, you do not need to register if you sell only in your own country.

 

What’s involved in TPD registration?

 

TPD Registration involves submitting information about your business to the agency responsible for vape products. The process is relatively quick and easy it should take no more than a hour to complete the form. Please contact us if you have any questions regarding the registration process.

 

Cross-Border Distance Sales

 

The TPD also sets out rules on cross-border distance sales of e-cigarettes and e-liquids. The regulations give EU member states the option of prohibiting cross-border distance sales. For example, the UK has the option of banning businesses within the UK from selling e-cigarettes and e-liquids to other member states (e.g. via the internet, telephone or mail order), and other member states from selling these products to consumers in the UK. Member states that choose not to prohibit cross-border distance sales are obliged to implement a registration scheme for any retailers that engage in them.

The UK has opted to allow cross-border distance sales, but companies engaging in these sales must register with the  MHRA. This means that UK retailers selling e-liquids online, by phone or by post to consumers in other member states (that have chosen not to impose a ban) must register with the MHRA and the authorities in the member state the consumer is based in. Non-UK businesses selling to UK consumers must also register with the MHRA.

 

 


Annual Sales Reporting

 

Under the Article 20.7 of the TPD, vape businesses are required to submit an annual report with sales information to the Agencies. The report should relate to sales in the previous year. Rules on annual reporting differ slightly market-to-market but the main points are presented below.annual-sales-report-tpd-ecig_2018

What information should be in the annual report?

 

The following information for each notified product should be included:

  • Sales volumes: Indicate the number of units sold (for multipacks count the number of individual units)
  • Mode of sale: Indicate how the product was sold – via website, through distribution channel, retail outlet etc.
  • Market Surveys: What market research has been done on your products/brand? What do customers like about a product? Provide a summary of the findings in the report.
  • Consumer Preferences: Write about the type of customer buys your product. Who typically buys your products? They may be an ex-smoker, in their 30’s, for example.

 

When should the report be submitted?

 

The deadlines for submitting the report differ across the EU: The UK want the report by May; Germany by June. Some agencies have asked for the report as early as March.

 

How should the information be submitted?

 

Again, rules differ across the EU. Two options are available: 1) the EU-CEG – the portal by which notifications are submitted – 2) direct to the agency by email. The UK asks that if the report is submitted via the portal, a copy of the report is sent by email too. We can advice on the country-specific requirements – contact us for more information.

 


Read more about the TPD Regulations here.


 

Are all products required to be in the report?

 

No. Only notified products are required to be included in the report.

 

What happens if the report is not submitted, or it’s late?

 

It depends on the market. Some authorities charge a penalty fee if the report is not submitted or is overdue. However, it is unlikely to come get to that stage especially because the requirements are still quite new.

 

Why do they want the data?

 

Ultimately, the authorities are collecting the sales information to answer the question: Does vaping lead to nicotine addition and/or smoking among the young and non-smokers?

 

The information they receive forms part of the research into vaping and the ‘gateway effect’.

 

If you feel you lack the required information – don’t panic.

 

We are familiar with the requirements across the EU and can provide solutions to help you submit quickly and efficiently.

Penalties for non-compliance

 

What are the penalties for non-compliance with the TPD?

 

Vape businesses can receive penalties for not complying with the provisions in the TPD.  In the UK, a vape business could receive a penalty for any of the following offences:

 

  • Failure to adhere to rules on product characteristics
  • Failure to submit a notification
  • Failure to establish and maintain a vigilance system
  • Failure to inform the MHRA if a manufacturer has reason to believe that an e-cigarette or refill container is not safe, of good quality, or compliant with the regulations.
  • Failure to immediately take corrective action to bring product into compliance (or withdraw the product, recall the product).
  • Failure to comply when any Member State asks a producer to provide information on the safety and quality aspects or any adverse effects of electronic cigarettes or refill containers, by a reasonable date.
  • Failure to inform MHRA, and an authority of any Member State in which the product has been supplied, details of risk to human health, among other things.

 

The severity of the penalty will vary between Member States. But in the UK, a person found guilty of an offence can lead to maximum 2-year imprisonment or a fine, or both.

 

Provided the vape business addresses the compliance issues in a timely manner and communicates with the health authority it is unlikely to lead to a penalty as severe as imprisonment. A TPD consultant can facilitate the communication and support the producer to correct the issue.

Useful Links

Which lab should you use for e-liquid testing?

What should appear on the e-liquid warning label?

Read our notes on the TPD Requirements.

Get a product notified

“The regulatory support we received over the past 2 years has been fantastic. It has been professional and reliable and the best we’ve found. From assisting us with the notifications to e-liquid testing they’ve helped get us TPD compliant and even saved us money.

We will continue to get their advice on all regulatory matters.”

Sam (E-liquid Manufacturer)

9 Things You Don’t Need! (To Be TPD Compliant)

 

Lots has been written about what you need to do to comply with TPD. But what don’t you need?  What is NOT required? Little is said on this topic but it is equally important.

Some of the things that are not requirements of the TPD are explored below:

1) Lab testing at an MHRA/FDA Approved Lab

2) ‘TPD Certificate’ or ‘Approval by agency ’

3) E-liquid Analysis by GC-MS and ‘screening’

4) GC-MS to identify e-liquid composition (formulation)

5) Nicotine delivery per dose for e-liquids

6) Good Manufacturing Practice

7) Quality Management Systems (QMS) (e.g. ISO 9001)

8) Health Criteria Values (HCVs)

9) Toxicological Risk Assessments (TRA’s)

1) Lab testing at an MHRA/FDA Approved Lab

 

Sending ecigs to be tested at a lab that has been ‘approved’ by the MHRA or FDA is not a requirement of the TPD. And it is unlikely to ever be a requirement.

But vape products should not be tested at just any lab. When sourcing a lab to do your testing, you should check:

 

  • Independent from the vape industry: Check that the lab has no ties with manufacturers or other vape businesses. Why? Because your test results should be treated as confidential and should only be known to the lab, your company and the authorities*.

 

  • Well-established: Ensure that the lab has been around for a few years and works in different sectors, such as pharmaceutical or agrochemical.

 

  • Language: We recommend testing using labs in the UK because the test generates a report that needs to be understood by the agencies in the EU. English is the common language in which all agencies can communicate.**

* There may come a time when the results are published but not for some years.

** Ideally, translations into the native language would be beneficial.

2) ‘TPD Certificate’ or ‘Approval by agency’

 

There is no such thing – the authorities (MHRA) will not issue you with a TPD certificate nor ‘approve’ the product. In the case of the UK authority, the MHRA, they will do some basic compliance checks and simply indicate that the manufacture ‘declares’ compliance with the TPD.

 

What does this mean?

 

It means the onus is on the manufacturer to confirm that the product complies with the rules for the TPD rather than the health authority issuing an ‘approval’.

 

What checks do the agencies make?

 

Each agency is different. The MHRA make a number of basic checks to ensure the essential elements of the notification are included. They do not disclose what exactly they check but from our experience, they will check that, at least, the tox and emissions data broadly complies with the TPD requirements, and declarations are included, among other admin information.

3) E-liquid Analysis by GC-MS and ‘screening’

 

E-liquid analysis by GC-MS is not strictly a requirement of the TPD but the picture is a little more complex. For TPD notification purposes, we do not advise our clients to get an analysis on the e-liquid – at least, not at this early stage of TPD regulation.

 

There will come a time for GC-MS testing on the e-liquid. This type of testing will form part of the manufacturing standard in development (see GMP manufacturing below).

 

In some cases, there may also be a requirement for GC-MS testing perhaps because of a compliance issue highlighted by an agency.

 

If not test on the liquid, what is testing required?

 

To get the e-liquid through the notification process, the only test required is one on the emissions where the e-liquid is put into a device, activated and the chemicals/metals that are emitted are reported.

 

For both e-liquid and devices, apart from an emissions test no other tests are required.

4) GC-MS on e-liquid composition (formulation)

 

An attempt to identify the chemical composition and quantities of an e-liquid with a sufficient degree of accuracy is, in most cases, futile and not a worthwhile activity. The only way to really know the ingredients and quantities in an e-liquid is to know the formulation.

5) Nicotine delivery per dose for e-liquids

 

An emissions test to check the amount of nicotine delivered per dose (sometimes seen on e-liquid bottles as 0.1 mg per puff) is not required for e-liquids but it is for devices.

 

Why not? Many factors play a part in the in amount of nicotine delivered per dose – the eliquid is one but other factors play a more important role, for instance, the device.

 

Nicotine delivery per dose is a requirement for devices (which should be printed on the pack).

6) Good Manufacturing Practice

 

Good Manufacturing Practice is not a requirement of the TPD. The TPD does not state GMP as a requirement and the manufacturing standards in development are unlikely to require it.

 

GMP is required for the manufacturing of medicines and standards for e-liquid manufacturing currently in development are expected to raise the bar closer to the medicines standard. But, in our view, they will fall short of a requirement for GMP.

7) Quality Management Systems (QMS)

 

QMS (e.g. 9001) is not a requirement of the TPD. Businesses may wish to implement a QMS for operational improvements or creditability reasons but the TPD does not require companies to have one.

 

The TPD does state that manufacturers and importers keep a system for collecting suspected adverse events which is different to a QMS. (See our Vigilance page).

8) Health Criteria Values (HCVs)

 

For peace of mind, a manufacturer may want to get HCVs for e-liquids – but these are not a part of TPD compliance.

9) Toxicological Risk Assessments (TRA’s)

 

TRA’s are not a requirement of the TPD. But again, for peace of mind, a manufacturer may prepare one.

 

What tox is required?

 

Information in the literature search on the available toxicological information on each ingredient should be presented. Read more here.