The Tobacco Products Directive – or TPD is a set of guidelines for the manufacture and sale of e-cigarettes and eliquids within the EU. The directive was put into effect in May 2016. All products must be TPD compliant prior to being placed onto the EU market.
The main guidelines of the TPD are:
1.) The characteristics of the new products have to meet the standards pertaining to 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 must have a health warning should be in the language of its nationality.
4.) Classification of labels and packaging regulations (CLP) For E-liquids, there are regulations regarding the labelling of mixed substances which are separate 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.) Production registration 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 get started?
The EU has introduced new rules in a revision of earlier laws that were in force for more than a decade and had not kept up with the most recent scientific and market advancements.
The TPD 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 laws are an element of a larger tobacco policy, which aims at reducing the use of tobacco by young people and helping smokers quit. The TPD was anticipated to have an impact on both.
What are the goals that the TPD?
The TPD is designed to:
Harmonize and update legislation to the prevention of tobacco use, and create a framework of regulation for similar products.
Reducing smoking by preventing products containing tobacco from containing ingredients or presenting that encourage youngsters to try it.
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 the visible and invisibly visible components.
Set up a safe and controlled environment for e-cigarettes and liquids to ensure they comply with requirements for safety and market 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 slightly more complex. Each device is covered under the terms of the TPD However, not all components of a device must be informed. Parts that are specific to electronic cigarettes (like tanks) must be informed however, generic components like batteries (‘mods’) don’t.
If you’re not certain if your item is covered by TPD contact us with us.
Do you know of any TPD loopholes in the TPD?
There are many TPD loopholes often used to get around the rules – we’ve covered 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-based liquids. To get around this restriction, some companies have come up with various’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, so that customers are able to fill the bottle with nicotine-containing e-liquid once they’ve purchased the bottle.
The consumer can purchase the short-fill in conjunction with nicotine-only (no flavor) E-liquid (a “nic shot”) and then combine them to make a nicotine-e-liquid refill.
Because short-fills don’t contain nicotine, TPD rules don’t apply. This means that manufacturers can bypass restrictions like the size of bottles and requirements for notification.
What do health authorities have to say regarding short-fills?
Health authorities interpret TPD differently across the EU. The majority of agencies do not regulate short-fills as per TPD rules, though certain do. The UK’s regulatory body known as the MHRA has declared that they won’t regulate short-fills since they do not contain nicotine and that manufacturers and importers must comply with General Product Safety Regulations (GPSR) instead. This is why, to be in compliance will require lab testing.
Tube Extenders
2.) Manufacturers may offer a tube in conjunction with an TPD certified tank. The TPD limits tank sizes to 2ml. Some manufacturers of devices circumvent this restriction by including tubes in their kits that can be combined with other components to create tanks that is larger than 2ml. The fact that the tube isn’t a tank does not mean it’s not required to be in compliance to the TPD size limit.
What do health officials have to say about tubes?
Again, interpretations differ across Europe. Some authorities are looking to shut this tube TPD loophole within their countries however, others do not specifically discuss the problem. Agents may ask producers and importers regarding the issue , and request an explanation of the manner in which the product conforms with the regulations.
In the UK In the UK, the MHRA has sent out emails to companies that have filed TPD notification with the information:
Tanks that exceed 2 ml
Items that contain non-essential elements that can temporarily alter capacity of tanks including plastic bungs and plugs, are subject to scrutiny 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 mod in a box comprising a battery and bottle or reservoir. It allows users to fill 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. This forces liquid upwards through the bottle’s nozzle, through the connector, then finally in the RDA. The major advantage over the conventional mod is that you can include e-liquid into the RDA more easily.
Mods in squonk boxes TPD conforming?
The issue with squonks lies in that some agencies (such like the MHRA) could think of the reservoir as to be a tank. In accordance with TPD rules, tanks should be less than 2ml.
The MHRA has released an official statement (not accessible on the internet) regarding squonk box modifications :
Squonkers
These products don’t conform to the regulations when they are used with a squonk squonk/reservoir bottle or tank with a different name, with a capacity greater than 2 ml. The refill containers that are supplied with a squonker have to comply with the applicable regulations.”
Therefore, the answer is no Squonk Box Mods aren’t TPD conforming.
Do you require a license to sell E-liquid?
However, you may be required to register your business by a local authority within the state that you’re selling your products in.
Who is required to sign up?
Regulations for registration differ from market to market but generally, you’ll have to sign up if selling nicotine-containing eliquids online to other EU states (see cross-border distance sales in the next section). In the majority of markets, you do not have to sign up for sales that are only within your country.
What exactly is TPD registration mean?
TPD registration requires you to provide information regarding your business to the company that is that is responsible of vape-related products. The process is simple and quick to complete – it shouldn’t take more than one hour to fill out the application.
Cross-border distance sales
The TPD provides rules regarding crossing-border distance sales of electronic cigarettes and electronic liquids. The laws allow EU members the option of preventing the sale of distance products across borders.
For instance for example, the UK is able to bans UK companies from selling electronic cigarettes and e-liquids in other members (e.g. via the internet, phone or mail) and also preventing different member states are prohibited from selling these products to customers who reside in the UK.
Member states that decide not to restrict cross-border distance sales must have an authorization scheme for sellers who engage in the practice.
Menu