All tobacco product notifications within the European Union must be submitted through the EU Common Entry Gate (EU-CEG) platform. This system ensures standardized submission of information on ingredients, emissions, toxicology, and product design to the competent authorities in each Member State.
Information required from manufacturers and importers submitted to the competent authorities:
- Full list of ingredients used in the manufacture of tobacco products, including quantities, listed in descending order by weight;
- Information on emissions and their levels from the tobacco products;
- Available internal and external studies and market research (including summaries) relating to ingredients and emissions, particularly regarding effects on public health and attractiveness to various groups, including young people.
The ingredient list must include:
- Rationale for the inclusion of each ingredient in the tobacco product;
- Ingredient status under Regulation (EC) No 1907/2006 (REACH) and classification under Regulation (EC) No 1272/2008 (CLP);
- Relevant toxicological data on each ingredient in burnt and unburnt form, especially regarding consumer health impacts and addictiveness.
Manufacturers and importers must identify any trade secrets during the notification process.
In the event of changes in product composition, competent authorities must be notified.
New or modified tobacco products must be notified prior to being placed on the market.
Manufacturers and importers are also required to submit annual sales volume data by brand and product type, in units or kilograms, broken down by EU Member State.
For cigarettes and roll-your-own tobacco, a technical document must be provided with a general description of additives and their properties.
For ingredients other than tar, nicotine, and carbon monoxide, and for emissions, manufacturers must specify the measurement methods used.
Electronic Cigarette Notification
Information required from manufacturers and importers during notification of e-cigarettes and refill containers:
Manufacturers and importers must notify competent authorities of each product they intend to place on the EU market, at least six months in advance, via electronic submission.
Each significant product modification also requires a new notification.
The submission must include:
- Name and contact details of the manufacturer or legal entity within the EU, and importer if applicable;
- Full list of ingredients and emissions by brand and product type, with quantities;
- Toxicological data for all ingredients and emissions, including after heating, with emphasis on health risks and addictiveness;
- Nicotine dose and uptake information under normal or reasonably foreseeable conditions;
- Description of product components and manufacturing process;
- Statement of full responsibility by the manufacturer/importer for product quality and safety under normal or foreseeable use conditions.
The manufacturer or importer must ensure that:
- Nicotine-containing liquids are only sold in refill containers not exceeding 10 ml, or in single-use cartridges or tanks not exceeding 2 ml;
- Nicotine concentration does not exceed 20 mg/ml;
- No prohibited additives are present in the nicotine-containing liquid;
- Only high-purity ingredients are used, and non-ingredients appear only in trace levels if technically unavoidable;
- All components are safe when heated or unheated;
- Nicotine is delivered consistently under normal use;
- Products are child-resistant, tamper-proof, shatter-proof, and leak-proof, and offer refill systems that prevent leakage.
Herbal Smoking Products – Notification Requirements
Manufacturers and importers must submit:
- List of all ingredients, including quantities, used in the product, broken down by brand and type.
Any changes in composition must also be reported to the competent authority.
All required data must be submitted before placing a new or modified product on the market.
HOW TO SUBMIT A NOTIFICATION
Notifications must be submitted electronically through the EU-CEG (European Common Entry Gate).
Upon registration in the ECAS system, you will receive a Submitter ID, which must be used in all communications and product notifications submitted via EU-CEG.
- Create an account in the European Commission’s ECAS system.
- Fill out and submit the application form with as much detail as possible, including optional fields and supporting documents (e.g., business registration, utility bills, tax declarations).
Once you receive your Submitter ID, you can transmit information through two options:
- Standalone application (suitable for smaller companies): Use the XML data generator to create notifications, which can then be uploaded into EU-CEG.
- System-to-system interaction (for larger infrastructures): Requires access to the EU’s e-Delivery network, managed by the European Commission. Their IT services will guide you in setting up the technical solution.
More information:
https://health.ec.europa.eu/euceg/introduction_en