The Tobacco Products Directive – or TPD is a set of guidelines regarding the production and sale of electronic cigarettes and e-liquids within the EU. The directive was put into effect in May 2016. All products must be conforming to TPD regulations before being put onto the EU market.
The most important guidelines of the TPD are:
1.) The characteristics of the new products should meet specifications regarding their design. This includes the volume of the bottle (max. 10 ml), tank size (max. 2 ml), child-resistant/tamper-evident packaging and refill mechanism technical rules.
2) Notification: Product information – for example, product characteristics, formulation/toxicology and emissions – must be submitted to the MHRA via the EU-CEG portal prior to product launch.
3.) Labelling and packaging The new regulations apply to labelling and packaging. concerning the packaging. For instance the wording “health warning” must be included on the label as well as certain warnings and precautions are required to be within the information leaflet. Every EU member state has a health warning must be in the language of its nationality.
4.) Classification of labels and packaging regulations (CLP) When it comes to the e-liquids, there’s a set of rules regarding the labelling of mixed substances that are distinct and predate the current vape laws. They include the requirement of an exclamation point or skull and crossbones icon and the precautionary statement.
5.) Production registration Businesses must register with authorities (where appropriate) in order to sell directly to consumers via the Internet.
What was the process that led to the TPD get started?
The EU has introduced new rules as a change to the earlier laws that had been in effect for more than a decade, and did not reflect the most recent scientific and market advancements.
To be TPD compliant was designed to bring about a more uniformity in the law on tobacco and other related products (roll-your-own cigars, cigarettes, e-cigarettes) throughout the EU. The new legislation is part of a wider tobacco policy, which aims at reducing smoking among youth and helping smokers quit. The TPD was anticipated to have a positive impact on both.
What are the goals that the TPD?
The TPD will:
Revise and harmonize legislation for the prevention of tobacco use, and create an appropriate regulatory framework for the related products.
Reducing smoking by preventing products containing tobacco that contain ingredients or presentation that encourage youngsters to smoke.
Combat illegal trade with the introduction of an European-wide tracking and tracing system to trace the legal supply chain, as well as an enhanced security system that integrates both invisible and visible elements.
Create a regulatory framework for e-cigarettes and liquids to ensure that they are in compliance with the safety and quality standards.
Does the TPD an obligation of law?
Yes, with a few certain exceptions. E-liquids can only be in compliance with the regulations of the TPD when they are containing nicotine. For devices, things get somewhat more complicated. Every device falls within the scope of the TPD However, not all components of a device require notification. The components that are exclusive to electronic cigarettes (like tanks) are required to be notified while generic parts such as batteries (‘mods’) don’t.
If you’re unsure if your item is within the definition of TPD contact us with us.
Is there any TPD loopholes in the TPD?
There are many TPD loopholes often used to gain advantage – we’ve listed some of these below.
Short-fills (‘shake and vape’)
1.) E-liquids are only required to conform to TPD if it is containing nicotine. The TPD is only applicable to nicotine-rich E-liquids. To get around this restriction, some companies have come up with short-fills or’shake and vape’ items.
Short-fills are refills that don’t contain nicotine and are typically sold in bottles of 100ml. They’re filled less than the recommended amount by the manufacturer to allow customers are able to fill the bottle with nicotine-containing e liquid after having purchased the bottle.
Consumers can buy the short-fill along with a nicotine-only (no flavor) E-liquid (a “nic shot”) and then combine them to create a nicotine e-liquid refill.
Because short-fills don’t contain nicotine, TPD rules don’t apply. Manufacturers can therefore bypass restrictions like sizes of bottles or notification requirements.
What do health officials have to say regarding short-fills?
Health authorities interpret TPD differently across the EU. The majority of agencies do not regulate short-fills in accordance with TPD rules, though certain do. The UK’s regulatory body called the MHRA has stated that they won’t regulate short-fills as they do not contain nicotine and that manufacturers and importers should adhere to General Product Safety Regulations (GPSR) instead. This is why, to be in compliance will require lab testing.
Tube Extenders
2.) Manufacturers are able to offer a tube in conjunction with an TPD certified tank. The TPD limit tank size to 2ml. Certain device makers circumvent this limitation by incorporating an empty tube inside the kit that can be combined with other components to create an oversized tank that is bigger than 2ml. The fact that the tube isn’t a tank does not mean it isn’t required to conform in accordance with TPD size limitation.
What do health authorities suggest about tubes?
Again, interpretations differ across Europe. Some authorities are looking to end this tube TPD loophole within their nation however, others do not specifically deal with the problem. Agents may ask producers and importers regarding the matter and demand an explanation of the way in which the product is compliant with the regulations.
In the UK In the UK, the MHRA has sent out emails to companies that have sent TPD notification with the information:
Tanks that exceed 2 ml
Products that are found to have non-essential elements that can temporarily alter the size of the tank including plastic bungs and plugs, will be reviewed in the event that they are not currently being notified. Any products that are found to have tanks with capacities that exceed 2ml will be taken off the list of approved products.
Squonk box mods
A “squonk” is a type of box mod which consists of a battery as well as bottle or reservoir. This allows users to charge the attached RDA from the bottom instead of drips from above. To add e-liquid into the RDA it is necessary to press the bottle. The liquid is pushed up the bottle’s nozzle into the connector, and then to the RDA. The primary benefit over the standard mod is that it allows users to add liquids to the RDA more easily.
Are mods for squonk boxes TPD in compliance?
The issue with squonks is that some agencies (such like the MHRA) could be able to consider the reservoir to be to be a tank. In accordance with TPD regulations, tanks have to not exceed 2ml.
The MHRA has released an announcement (not accessible on the internet) on the mods to squonk boxes :
Squonkers
These products don’t comply with the regulations if they are supplied with a squonk bottle/reservoir , or a tank under any other name that has a capacity of more than 2 ml. The refill containers that are supplied with a squonker have to comply with the regulations applicable to them.”
The answer is yes Squonk box mods aren’t TPD compatible with TPD.
Do you require a license to sell E-liquid?
However, you may have to register your company by a local authority within the state that you’re selling your products in.
Who is required to sign up?
The rules for registration vary from market to market however, generally you’ll need to sign up if you sell nicotine-containing eliquids online to other EU states (see the section below on cross-border distance sales). In many markets, you do not have to register when you only sell in your country.
What is TPD registration entail?
TPD registration requires you to provide information about your company to the company that is that is responsible to regulate vape product. The process is fairly simple and fast and should not take more than one hour to fill out the form.
Cross-border distance sales
The TPD establishes rules for the cross-border sale of e-cigarettes and liquids e-cigarettes. The laws allow EU members the option of preventing the sale of distance products across borders.
For instance For instance, the UK is able to prohibiting UK companies from selling electronic cigarettes and e-liquids to state members (e.g. through the internet, by phone or mail) and also preventing the other states of membership from offering the products to consumers within the UK.
States that do not choose to ban cross-border sales are required to establish a registration system for all sellers who engage in these transactions.
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