AISILE

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Regulatory hub
AISILE Replacement Pods

EU rules for prefilled pods, before TPD3 moves them.

The EU framework is under revision. This page sets out the limits that govern a pod today, the notification reality across 27 member states, and how to design a range that does not need retooling when the ceilings move.

TPD Article 20Notify per member stateTPD3 expected Q4 2026

The governing framework

TPD Article 20, state by state

Directive 2014/40/EU sets one envelope for the whole Union, but access to it is granted 27 times over. The product is designed once; the paperwork is filed per country.

A range built for 2027 should assume the ceiling can move. Keep the pod geometry modular so a change in capacity or permitted format re-specifies the pod without invalidating the host device.

Governing law
Directive 2014/40/EU (TPD), Article 20
Applies to
27 EU member states
Nicotine ceiling
20 mg/ml
Pod / tank ceiling
2 ml
Refill container
10 ml maximum, with limits on nozzle size
Notification
Per member state via EU-CEG, six months before sale

The UK inherited the same 2 ml / 20 mg/ml envelope, so one compliant configuration travels from Berlin to Birmingham unchanged — only the filings differ.

Hard limits

What TPD fixes today, and what it does not

The directive fixes the product envelope EU-wide. Everything around single-use products and flavours is left to the member states, which is where the divergence lives.

Table 1 — EU position for a prefilled pod order.
ItemEU positionEffect on your project
Nicotine strengthMaximum 20 mg/mlCeiling for every pod SKU sold in the EU
Pod / tank capacityMaximum 2 mlSame chamber limit as the UK; shared tooling
Refill containerMaximum 10 mlApplies if you also ship bottled liquid
EU-CEG notificationPer member state, 6 months before saleMulti-state filing; fees differ by state
Single-use vapesNo EU-wide ban; member states decideBelgium removed them in 2025; others in progress
FlavoursNo EU-wide ban; some states restrictVerify the destination state before naming ranges
TPD3Proposal expected around Q4 2026Design hardware modular to today's ceilings

Swipe the table sideways to see every column →

The notification workload is the part buyers underweight. Six months of lead time per state, filed six months before the product ships, means the regulatory calendar starts before the tooling order does.

Timeline

How the EU got here

2014

TPD2 adopted

Directive 2014/40/EU fixes the Article 20 envelope: 20 mg/ml, 2 ml tanks, 10 ml refills, prescribed warnings.

20 MAY 2016

Rules apply EU-wide

Member states transpose the directive. EU-CEG becomes the single notification channel, filed per country.

2025

Member-state single-use bans

Belgium removes single-use vapes from sale; other states move on their own timetables. No EU-wide ban exists.

Q4 2026 (expected)

TPD3 proposal

Ceilings, flavours and environmental rules all on the table. Treat every current position as provisional until the text lands.

Buyer checklist

Five things to settle before you quote an EU launch

01 · Confirm the format
Rechargeable host, swappable prefilled pod
02 · Design to 2 ml / 20 mg/ml
The envelope the UK shares, so one build serves both
03 · Map the filings
One EU-CEG notification per destination state, fees differ
04 · Track TPD3
Avoid hardware commitments that assume today's ceilings
05 · Name the responsible person
Notification sits with the brand holder in each state

The AISILE platform is built to the 2 ml / 20 mg/ml envelope by default, and the pod geometry stays modular so a TPD3 re-specification does not retool the device.

Questions

EU questions buyers ask first

No. Under TPD Article 20 every member state runs its own notification, filed through the EU-CEG system at least six months before the product is placed on that market. One EU launch is a multi-state filing exercise, and fees differ by state.

20 mg/ml maximum nicotine strength, a 2 ml maximum tank or pod capacity, and 10 ml maximum for refill containers, with prescribed health warnings on packaging. These are the same ceilings the UK applies, so a single 2 ml / 20 mg/ml configuration serves both.

There is no EU-wide ban. Single-use restrictions are decided member state by member state — Belgium removed them from sale in 2025 and others are moving — so check the destination country. A rechargeable host with swappable prefilled pods stays outside every single-use definition proposed so far.

TPD3 is the pending revision of the Tobacco Products Directive, with a proposal expected around Q4 2026. Ceilings, flavours and environmental rules are all on the table, so treat today's positions as provisional and keep pod hardware modular enough to re-specify.

No. It is a summary of published rules intended to help a buyer frame a project. Confirm the current position with your own regulatory consultant before you rely on it.

Next step

Designing for the EU? Send the brief and the destination states.

The factory configures to the 2 ml / 20 mg/ml envelope by default and will say plainly when a requirement sits outside it.

EU enquiries

Selling prefilled pods into the EU?

Send your destination states and volume band and we confirm the TPD-ready configuration, the manufacturer-side documentation each notification needs, and the lead time on a trial run.

Email
moyucong@yunmiaonet.cn
WhatsApp
+86 15561912527
Sampling
7–15 days
Production
15–30 days
MOQ
Set per SKU — tell us your target volume

Request a quote

Fields marked with an asterisk are the ones our factory team needs to quote accurately.

Drives the compliance paperwork we prepare with your order.

Typical first response within one working day. We reply from Shenzhen, GMT+8.

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