Most compliance failures do not happen in the factory. They happen because a distributor assumed the supplier had filed something the supplier was never legally able to file. This is the checklist we walk through with every new EU buyer.
1. Start with the product definition
EU rules under the Tobacco Products Directive (2014/40/EU) treat a disposable vape as an electronic cigarette. That single classification drives everything else: nicotine strength limits, the notification obligation, labelling rules and the emissions data you must hold.
- Nicotine limit: 20 mg/ml maximum for e-liquid placed on the EU market.
- Volume limits: refill containers are capped at 10 ml; the tank or reservoir limit applies to refillable devices.
- No health claims: any statement implying reduced harm needs separate authorisation.
Disposable devices with sealed reservoirs sit slightly differently from refillable tanks, which is exactly why you want the classification confirmed in writing for the specific product you are importing.
2. The notification obligation sits with you
Article 20 requires manufacturers and importers to submit a notification to the competent authority of each member state before the product is placed on that market. In practice:
- You cannot notify a product you have not yet imported — but you cannot import it until it is notified. This is why notification is a pre-order activity, not a post-shipment one.
- Most authorities operate a submission portal and charge a per-product fee; several require the notification a set period before the market launch date.
- You will need the technical file from your manufacturer to complete the submission.
This is the step where a clear division of labour matters. As the manufacturer we prepare the technical file. As the importer, you file. Any supplier claiming to have “done the TPD” for you is usually referring to the file, not the filing.
3. The technical file your manufacturer must supply
| Document | What it covers | Supplied by |
|---|---|---|
| Product specification | Device type, reservoir volume, coil resistance, output power, nicotine strength | Manufacturer |
| Ingredient data | Full e-liquid composition with CAS numbers and nicotine purity | Manufacturer |
| Emissions testing | Aerosol analysis carried out to the applicable method | Accredited lab |
| Non-clinical testing | Toxicological data on the e-liquid and its ingredients | Accredited lab |
| MSDS | Safety data sheet for the e-liquid and for the battery | Manufacturer |
| UN38.3 report | Lithium battery transport test summary | Cell supplier / lab |
| CE / RoHS / WEEE | Electrical safety, restricted substances and waste electronics declarations | Manufacturer |
| Notification submission | The in-country filing with the competent authority | Importer / distributor |
4. Labelling and packaging
- Health warning: the prescribed text must appear in the official language(s) of the member state, occupying the required share of the front and back surfaces.
- Ingredient list and nicotine content: stated on the pack, with the nicotine strength in mg/ml.
- Batch number: printed on the device or the unit pack so any batch can be traced and recalled.
- Child-resistant and tamper-evident construction where the rules require it for the device category.
- No promotional claims on pack or artwork.
5. Battery transport and logistics
Disposable vapes contain lithium cells, so air and sea freight need a UN38.3 test summary, the correct dangerous-goods documentation, compliant inner packaging and carton labelling. Freight forwarders that do not specialise in battery goods will hold your container at origin, which is how a 25-day lead time becomes a 60-day one.
6. Age verification and advertising
Distance-selling rules require age verification for online retail, and cross-border promotion of vaping products is restricted in most member states. As a B2B seller you are not exempt from the underlying product rules — you are just one step earlier in the chain.
Country-by-country differences are the real risk
Several member states layer national restrictions on top of the TPD, including flavour restrictions, plain-packaging requirements and outright bans on disposables. None of that is harmonised. Before you order, confirm the current national position in the specific countries you plan to sell into — and re-check it before each reorder, because these rules change faster than container cycles.
Quick pre-order checklist
- Confirm the product classification and nicotine strength against the target market.
- Confirm the national position on disposables in each country you sell into.
- Request the full technical file and verify test reports are current and match the SKU.
- Book notification submission timing before you place the production order.
- Approve packaging artwork in the correct language with the correct warning surface share.
- Confirm your forwarder handles lithium battery goods and has the UN38.3 summary on file.
- Put age-verification in place for any online channel.
The wholesale terms page lists exactly which documents we supply with each shipment, and our product range shows which configurations are available for TPD-compliant builds.