EU-CEG NOTIFICATION UNDER TPD
We provide all TPD required information on your e-cigarette and refill container products, though the EU Common Entry Gate (EU-CEG). The notification files are submitted to relevant EU member states, in which you intend to market your products.
POISON CENTERS NOTIFICATION (UFI)
We submit notification files, represented by a Unique Formula Identifier (UFI) code, for each of your hazardous liquids, to EU poison centers.
C&L INVENTORY NOTIFICATION
We create and submit notification files, if relevant, for your hazardous substances to the European Chemicals Agency (ECHA) Classification and Labelling Inventory.
REACH REGISTRATION
We support you throughout the complex registration process including preparation and submission of the REACH registration dossier to the European Chemicals Agency (ECHA).
PIC NOTIFICATION
If you import or export nicotine-containing liquids from or to countries outside the EU customs territory, we can help you fulfil your obligations with respect to notification.
ANNUAL REPORTING
The TPD places an obligation on the manufacturers and importers of electronic cigarettes to submit annual reports on sales of their notified products. We can submit, to the relevant competent body, all relevant information as sales volume, available information on the preferences of consumer groups etc.
Depending on whether your product is an e-cigarette or an e-liquid there are different requirements for notification and registration. E-cigarette hardware must be notified under TPD to the national authorities six months before the intended placing on the market. Also, data on sales volumes must be reported annually to the national authorities.
E-liquids must also be notified under the TPD, and annual sales volumes reported. However, e-liquids are also subject to the European Chemicals legislation and potentially registration and notification. If you import more than 1 tonne of a substance, it must be registered under the REACH regulation. Are you an importer or manufacturer of an e-liquid, and it is hazardous according to the CLP regulation, the hazardous substances must be notified with ECHA’s classification and labelling inventory. If the e-liquid contains nicotine and is imported into the EU or exported outside the EU, annual sales or predicted sales volumes must be reported under the PIC (Prior Informed Consent) legislation.
E-liquids, which are classified as hazardous on the basis of their health or physical effects, must be provided with a Unique Formula Identifier (UFI) intended to help EU Poison Centers to be able to precisely identify the chemicals involved in an incident and provide adequate medical advice. This requires that relevant information on the mixture components are submitted to the appointed bodies (i.e, Poison Centers).
Our regulatory consulting experts can guide you through the notification- and registration obligations for your products or we can manage and carry out the notification and registration processes for you.
