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EU Vape Rules Under the TPD: The Limits Every Product Must Meet

Every nicotine vape sold in the EU must stay within Article 20 of the Tobacco Products Directive: 20 mg/ml of nicotine, 2 ml tanks and 10 ml refills, notified six months before sale.

The Berlaymont building in Brussels, headquarters of the European Commission
The Berlaymont building in Brussels, headquarters of the European Commission. File photograph. Photo: Romaine / Wikimedia Commons, CC0. Image: Romaine / Wikimedia Commons (CC0) Image source · CC0 · Display crop and size variants; source image content retained.

Key points

  • Article 20 of Directive 2014/40/EU caps nicotine in vape liquid at 20 mg/ml.
  • Refill containers are limited to 10 ml, and cartridges and tanks to 2 ml.
  • Manufacturers and importers notify national authorities six months before a product goes on sale.
  • The Commission opened a consultation on revising the directive on 22 May 2026.

Every nicotine vape sold in the European Union has to fit inside the limits written into Article 20 of the Tobacco Products Directive: no more than 20 mg/ml of nicotine, cartridges and tanks of no more than 2 ml, and refill containers of no more than 10 ml. Member states have applied Directive 2014/40/EU since 20 May 2016, and the European Commission is now preparing to revise it.

Four numbers set the baseline

Rule Limit under Article 20
Nicotine in the liquid 20 mg/ml maximum
Dedicated refill containers 10 ml maximum
Cartridges and tanks 2 ml maximum
Notification Filed electronically six months before a product is placed on the market

Ingredients and device safety

The liquid may not contain the additives listed in Article 7(6) of the directive, and only ingredients of high purity may be used. Ingredients other than nicotine must not pose a risk to human health in heated or unheated form, and the device has to deliver nicotine at consistent levels under normal conditions of use. Products must be child- and tamper-proof, protected against breakage and leakage, and refillable without leaking.

Notification comes before the first sale

Manufacturers and importers notify the competent authorities of the member states where they plan to sell, six months ahead of launch. After that they report every year, including sales volumes by brand name and type of product, so a new SKU cannot simply appear on a shelf the week it is shipped.

Leaflets, warnings and advertising

Each unit packet carries a leaflet on use, storage and risks, including a statement that the product is not recommended for young people and non-smokers. Member states choose between two health warnings, both of which open with “This product contains nicotine which is a highly addictive substance.”

Article 20(5) also restricts commercial communications for e-cigarettes in printed publications, online services, radio and audiovisual media, along with sponsorship of radio programmes and of events with a cross-border effect.

National rules sit on top

The directive sets a common floor for the single market rather than a complete rulebook. Matters it leaves open, including flavour restrictions, taxes and minimum sales ages, are decided nationally, so a product that meets Article 20 can still face different conditions from one EU country to the next.

A revision is in preparation

On 22 May 2026 the Commission opened a public consultation on revising the Tobacco Products Directive and the Tobacco Advertising Directive, pointing to the rapid emergence of novel tobacco and nicotine products, particularly among young people. The consultation ran until 14 August 2026, and the Commission has said the revision is planned before the end of 2026. Until a new directive is adopted and transposed, the Article 20 limits are the ones that apply, and distributors supplying several EU markets should track both the proposal and each country’s own rules.

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18+ only. This site is for adult readers and provides news and information only. It is not medical, legal or purchase advice. Nicotine is addictive. Always check the official text of any regulation in your market. Health Information

Adrian Cole

Adrian Cole covers vape regulation for VapeBrief. He spent nine years working in e-cigarette export compliance.

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