EU-TPD Notifications | EU TPD Notifications for JCGFRC

European Tobacco

EU tobacco directive

The European Tobacco Product Directive (ETPD) regulates the manufacture, marketing, labeling, and sale of tobacco and related products across the EU, ensuring public health protection and market compliance.

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ETPD Overview

Selling nicotine products in Europe and the UK

The EU Tobacco Products Directive (Directive 2014/40/EU) has applied since May 20, 2016. E-cigarettes and refill liquids must be notified to each target country through the EU Common Entry Gate (EU-CEG) at least six months before sale. The UK runs a parallel system through the MHRA under the Tobacco and Related Products Regulations 2016. JJCC Group prepares and files both.

Cigarettes, roll-your-own, cigars, cigarillos, pipe and waterpipe tobacco, smokeless tobacco, novel tobacco products such as heated tobacco, e-cigarettes, refill liquids and herbal smoking products. Tobacco-free nicotine pouches fall outside the TPD and follow national rules.

ETPD Guidelines

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Our Support

How can we support

JJCC Group has helped many of our clients and prepared and submitted 1000s notificiations to the EU-TPD and UK-MHRA. Our services include:

Nicotine concentration

20 mg/mL maximum

Refill container size

10 mL maximum

Tank or cartridge size

2 mL maximum

Packaging

Child-resistant and tamper-evident

Health warning

Nicotine warning on 30% of the two largest surfaces

Regulatory strategy

by country, including fees and national extras.

EU-CEG and MHRA submissions

including submitter ID setup.

Ingredient and emissions data

packages and testing coordination with accredited labs.

Toxicological assessments

of ingredients, by CAS number.

Full eu-tpd and uk-mhra tobacco compliance support

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What to watch

The EU is reviewing the TPD, and changes to flavors, nicotine limits and novel products are expected.
The UK banned single-use vapes in England, Scotland and Wales from June 1, 2025.
Northern Ireland follows EU TPD rules under the Windsor Framework.

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What our clients say about JJCC

Clients trust JJCC Group for expert FDA CGMP guidance, ensuring compliant, high-quality drug and biologics manufacturing.

JJCC streamlined our CGMP compliance process, making FDA audits easier and improving overall manufacturing quality.

Sarah Bennett OWNER

Absolutely! Their expertise in regulatory guidance and training has been invaluable for our drug and biologics operations.

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Their team provides consistent, professional support, ensuring our facility maintains full compliance and operational excellence.

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Faqs

Frequently asked questions

Our Frequently Asked Questions provide clear guidance on EU-TPD and UK-MHRA compliance, covering registration, labeling, testing, submissions, and ongoing regulatory requirements for tobacco products.

These answers help businesses understand obligations, reduce risks, and maintain compliant, safe, and market-ready products across European markets.

What is the EU Tobacco Products Directive?

Directive 2014/40/EU sets EU rules for making, presenting and selling tobacco and related products, including e-cigarettes. It has applied since May 20, 2016.

Who must comply with the TPD?

Manufacturers and importers placing products on an EU market. Distributors must make sure products they sell have been notified.

What is EU-CEG?

The EU Common Entry Gate is the online system for submitting TPD notifications. One submission can target several member states.

How far ahead must e-cigarettes be notified?

At least six months before placing them on the market. A substantial product change needs a new notification.

What is the maximum nicotine strength?

20 mg/mL for e-liquids. Refill containers are limited to 10 mL and tanks to 2 mL.

Do nicotine pouches need a TPD notification?

Tobacco-free pouches are not covered by the TPD. Many EU countries regulate them nationally, and some ban them.

What is required for heated tobacco products?

They are novel tobacco products and must be notified six months before sale. Characterizing flavors are banned in heated tobacco products.

Do I need emissions testing?

Yes. Notifications for e-cigarettes include emissions data, and tobacco products need ingredient and emission reports.

Are there fees?

Many member states charge notification or annual fees. Amounts vary by country.

How does the UK differ after Brexit?

Great Britain uses MHRA notifications under the 2016 UK regulations. Northern Ireland follows EU rules.

Can I sell disposable vapes in the UK?

No. Single-use vapes have been banned in England, Scotland and Wales since June 1, 2025.

What goes in the leaflet?

Instructions for use and storage, contraindications, warnings for at-risk groups, adverse effects, addictiveness and toxicity, and contact details.

Is ongoing reporting required?

Yes. Manufacturers and importers report sales volumes and market data every year, and must report new safety information.

Can one product be notified in several countries at once?

Yes. One EU-CEG submission can cover several member states, but labels must be in each country’s language.

How can JJCC Group help?

We prepare data packages, coordinate testing, file EU-CEG and MHRA submissions, review labels and keep you current as rules change.