The Tobacco Products Directive – or TPD is a set of regulations regarding the production and sale of electronic cigarettes and e-liquids within the EU. The directive was put into effect in May 2016. Every product has to be in compliance with TPD regulations before being put onto the EU market.
The main guidelines of the TPD are:
1.) The characteristics of the new products should meet standards pertaining to their design. This includes the size 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 Labelling and packaging: New rules have been introduced regarding packaging. For instance the wording “health warning” must be displayed on the label and certain precautions and warnings should be included on the label. Every EU member state has a health warning must be in the language of its nationality.
4.) Labelling classification and packaging regulations (CLP) When it comes to E-liquids, there are regulations for the labelling of mix-ups that are distinct and predate the current vape laws. They include the requirement of an exclamation point or skull and crossbones icon as well as precautionary warnings.
5.) Registration of the producer: Businesses must register with the appropriate authorities (where appropriate) in order to sell directly to consumers via the Internet.
What was the process that led to the TPD take shape?
The EU has introduced new rules as a change to the earlier laws that were in force for more than a decade, and had not kept up with the most recent scientific and market changes.
The TPD was designed to bring about a more uniformity in the laws governing tobacco and other related products (roll-your-own cigarettes, cigars, electronic cigarettes) all across EU. The new laws are 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 objectives for the TPD?
The TPD will:
Harmonize and update legislation to the control of tobacco and create an appropriate regulatory framework for the related products.
Reducing smoking by preventing products containing tobacco from containing ingredients or presenting that encourage youngsters to smoke.
Combat illegal trade by introducing 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 they comply with requirements for safety and market standards.
Do I Legally Need To Be TPD compliant?
Yes, but with some certain exceptions. E-liquids can only be in compliance with the guidelines of the TPD when they have nicotine. For devices, things get slightly more complex. Each device is covered under the terms of the TPD but not all components of a device must be informed. Parts that are specific to electronic cigarettes (like tanks) are required to be notified however, generic components like batteries (‘mods’) don’t.
If you’re not certain if your product is covered by TPD contact us with us.
Is there any TPD loopholes in the TPD?
There are a variety of TPD security loopholes frequently 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 circumvent this, some companies have come up with short-fills or’shake and vape’ items.
Short-fills are nicotine-free refills usually available in 100ml bottles. They’re not filled to capacity by the manufacturer to allow customers can refill the bottles with nicotine-containing e liquid after having purchased the bottle.
The consumer can purchase the short-fill along with a nicotine-only (no flavor) liquid (a “nic shot”) and mix the two 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 authorities suggest regarding short-fills?
Health authorities interpret TPD differently across the EU. The majority of agencies do not regulate short-fills as per TPD regulations, but certain do. The authority in the UK called the MHRA has declared that they won’t regulate short-fills since they do not contain nicotine and that manufacturers and importers should adhere to General Product Safety Regulations (GPSR) instead. This for compliance is a requirement for lab tests.
Tube Extenders
2.) Manufacturers may sell tubes in conjunction with the TPD compatible tank. The TPD limits tank sizes to 2ml. Certain device makers circumvent this limitation by incorporating an empty tube inside the kit that can be combined with other components to make tanks bigger than 2ml. The fact that the tube isn’t actually a tank does not mean it’s not required to be in compliance in accordance with TPD size limit.
What do health officials have to say about tubes?
Again, interpretations differ across Europe. Some authorities are looking to end this tube TPD loopholes in their nation and others do not discuss the problem. The agencies may take on the importers and manufacturers on the matter and demand an explanation of the manner in which the product conforms with the guidelines.
In the UK In the UK, the MHRA has sent out emails to companies that have sent TPD notices with this information:
Tanks that exceed 2 ml
Items that contain non-essential elements that can temporarily alter capacity of tanks like plastic bungs and plugs, will be reviewed in the event that they are not currently being notified. Products that have tanks with capacities that exceed 2ml will be taken off the list that is published.
Squonk box mods
A “squonk” is a type of box mod which consists of a battery as well as bottle or reservoir. It allows users to fill the attached RDA down the middle instead of pouring from above. To add e-liquid into the RDA users press the bottle. The liquid is pushed up the bottle’s nozzle, through the connector, and then to the RDA. The primary benefit over the standard mod is that you can include e-liquid into the RDA more quickly.
Mods in squonk boxes TPD in compliance?
The issue with squonks lies in that government agencies (such like the MHRA) could be able to consider the reservoir to be to be a tank. According to TPD regulations, tanks have to be less than 2ml.
The MHRA has released an official statement (not accessible on the internet) regarding squonk box modifications :
Squonkers
They do not comply with the regulations if they are supplied with a squonk bottle/reservoir , or a tank with a different name that has a capacity of more than 2 ml. Refill containers provided with a squonker need to be in compliance with the applicable regulations.”
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 be required to register your business through an official in the nation where you’re selling.
Who should register?
Regulations for registration differ between markets, however, generally you’ll need to sign up if selling nicotine-containing e-liquids online to the other EU states (see cross-border distance sales in the next section). In the majority of markets, there’s no have to register for sales that are only within your country.
What exactly is TPD registration mean?
TPD registration is the process of submitting details about your company to the organization that is responsible of vape-related products. The process is simple and fast and should not take more than an hour fill out the form.
Cross-border distance sales
The TPD establishes rules for the cross-border sale of e-cigarettes and liquids e-cigarettes. These laws provide 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 members (e.g. through the internet, by phone or mail) and also preventing the other states of membership from offering these products to customers within the UK.
States that do not choose to ban cross-border sales are required to establish an authorization scheme for sellers who engage in the practice.
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