Limite di nicotina 20 mg/ml: la regola TPD

18+ only · Regulatory explainer for EU vape wholesalers, distributors and retailers.

If you buy vape stock in the EU, one number governs almost every purchasing decision: 20 mg/ml. It is the maximum nicotine concentration permitted for e-liquid and for disposable devices under the Tobacco Products Directive. Get it wrong and the stock cannot be legally sold; get the sizing right and the same device can serve both the EU and export markets. Here is what the cap actually covers, where the ambiguity sits, and how it interacts with what your customers actually ask for.

What the 20 mg/ml cap covers

Directive 2014/40/EU sets a maximum nicotine concentration of 20 mg/ml for e-liquids, including the liquid inside a disposable device or a prefilled pod. The limit applies to the product as placed on the market — so it is measured on what is in the reservoir, not on a diluted or “as-consumed” basis. Anything above 20 mg/ml cannot be placed on the EU market regardless of how it is labelled or packaged.

20 mg/ml is 2% — and 5% is not allowed in the EU

The most common confusion in day-to-day wholesale is between mass concentration and percentage labelling:

The 5% SKUs that circulate widely in other regions are, in EU terms, non-compliant stock. They cannot be placed on the EU market, cannot be advertised to EU consumers, and should not be sold to EU retailers. If your supplier is offering you 5% devices for Consegna UE, the question to ask is which market they are actually intending to supply.

Why 20 mg/ml is a commercial constraint, not just a legal one

The cap drives three practical consequences for a wholesale buyer:

• SKU duplication. A brand sold at both 2% and 5% is effectively two product lines. Your EU-facing catalogue can only carry the 2% and 0% variants, which means your order sheet and stock counts need to separate them explicitly.
• Consumer substitution. Nicotine-seeking customers in markets where high-strength is unavailable will often trade up on device capacity instead — more puffs, larger battery, dual flavour — rather than on nicotine strength. That shifts demand toward long-puff formats.
• Export complexity. If you serve both EU and non-EU markets, you need either physically segregated stock or documented controls, because one mis-picked carton is a compliance event.

How the cap interacts with the 2 ml rule

The 20 mg/ml concentration limit works alongside a separate volume limit: a disposable or pod reservoir may not exceed 2 ml, and refill containers for open systems are capped at 10 ml. The two limits are independent — you cannot compensate for a low concentration by enlarging the tank.

The practical effect is that total nicotine per device is capped too: at 2 ml and 20 mg/ml, a compliant disposable holds a maximum of 40 mg of nicotine regardless of how many puffs it claims. That is why the marketing race in the EU has moved to puff count and flavour variety rather than strength.

Zero-nicotine in a regulatory grey zone

Products with no nicotine sit in an awkward position. Under TPD, “e-cigarettes” are largely defined by nicotine content, so a 0 mg/ml device may fall outside the TPD notification requirements in some member states — but several countries regulate nicotine-free vaping products separately, and national rules on retail licensing, advertising and youth access frequently still apply. Do not assume “0 mg” means “unregulated”. Check the position in each market you supply.

That said, for markets where nicotine disposables have been restricted, a compliant 0 mg line is often the only saleable disposable format. Ask us which SKUs are available in 0 mg.

What to check on every incoming order

1. Confirmed concentration on the pack, in both percentage and mg/ml. They must agree.
2. EU-CEG notification covering that exact strength. A notification for the 2% variant does not cover the 5% one.
3. Reservoir volume at or below 2 ml, and reorder containers at or below 10 ml.
4. Destination market rules — several member states go beyond TPD on strength-adjacent issues such as flavour categories and device type.

Where we stand

Every SKU we ship inside the EU is at or below 20 mg/ml with a matching EU-CEG notification. Higher-strength variants are held for verified non-EU and re-export buyers only, and are never listed in the EU-facing catalogue. The TPD compliance field guide covers the wider framework, and the compliance centre lists the documents we supply per SKU.

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Informational only, not legal advice. National rules can be stricter than TPD. Confirm the position in each market you supply with a qualified adviser.