If you are an importer or manufacturer of e-cigarettes or e-liquids, your products must be TPD compliant before you can sell in the EU. But what does it mean to be TPD compliant and how can Medic Pro help?
The key rules of the TPD include:
1) Product characteristics: New products must comply with requirements relating to their design. These include the size of 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) Packaging and labelling: There are new rules about packaging. For example, a health warning must appear on the label, and certain warnings and precautions must appear in the leaflet. Each EU member state health warning which must be in its native language.
4) Classification of labeling and packaging rules (CLP): With e-liquids, there are rules on the labelling of mixtures that are separate and pre-date the new vape laws. These include the requirement for an exclamation mark or skull and crossbones pictogram, and precautionary statements.
5) Producer registration: Companies must register with the authorities (where applicable) to sell directly to customers via the Internet.
How did the TPD come about?
The EU introduced the new rules as a revision to previous laws, which had been in place for over a decade and no longer reflected the latest scientific and market developments.
The TPD was designed to harmonise the laws of tobacco and related products (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 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 smoking by preventing tobacco products from using ingredients or presentation that encourage young people to take it up.
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-cigs and e-liquids to make sure 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, things are a little more complicated. All devices fall within scope of the TPD – however, not all a device’s components need to be notified. Components that are unique to e-cigarettes (like tanks) need to be notified, but generic parts like batteries (‘mods’) don’t.
Are there any TPD loopholes?
There are several TPD loopholes that are commonly exploited
Short-fills (‘shake and vape’)
1) An e-liquid only needs to comply with TPD 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’ or ‘shake and vape’ products.
Short-fills are nicotine-free refills typically sold in 100ml bottles. They’re under-filled by the manufacturer so customers can fill the bottle up with nicotine-containing e-liquid after they’ve bought it.
A consumer can purchase the short-fill together with a nicotine-only (no flavour) e-liquid (a ‘nic shot’) and combine the two to make a nicotine e-liquid refill.
Because short-fills don’t contain nicotine, TPD rules don’t apply. This means manufacturers can avoid things like restrictions on bottle size and notification requirements.