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E-liquids for electronic cigarettes are regulated by the Tobacco Products Directive (TPD, Directive 2014/40/EU). The TPD requires Member States to ensure that electronic cigarettes and their refill containers are only placed on the market if they comply with the TPD and with all other relevant Union legislation (Article 20(1)), including the obligations under the CLP Regulation.
Under CLP, the classification, labelling and packaging of an e-liquid is the responsibility of the formulators or importers of the liquid. Under TPD, they must also submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market. This notification should include the classification of the mixture in accordance with CLP.
The TPD sets its own labelling requirements for the unit packets of electronic cigarettes and refill containers (TPD Article 20(4)). In addition, the refill containers must also be labelled and packaged in accordance with CLP if the e-liquid is classified as hazardous. In that case, the unit packet must have a CLP label, with TPD-related information as supplemental. Overlapping information only needs to be indicated once: for example, the list of all ingredients required by TPD vs the list of ingredients contributing to classification under CLP.
It should be noted that the TPD provides that the nicotine content must not exceed 20 mg/ml and only ingredients that do not pose a risk to human health in heated or unheated forms may be used in the nicotine-containing liquid. However, other components of e-liquids have also been identified as hazardous and need to be considered in the classification and labelling of the e-liquid.
According to TPD, electronic cigarette devices and refill containers have to be child- and tamper-proof, protected against breakage and leakage and have to have a mechanism that ensures refilling without leakage (Article 20(3)g).
A refillable electronic cigarette device that is empty when placed on the market is not subject to the labelling obligations under CLP, as the hazards are dependent on the contents of the refill container.