TPD Requirements: Regulatory Notes on Article 20.3

 

An extract of the TPD requirements Article 20 along with regulatory notes on paragraphs 3 is presented below.

“3. Member States shall ensure that:

(a)  nicotine-containing liquid is only placed on the market in dedicated refill containers not exceeding a volume of 10 ml, in disposable electronic cigarettes or in single use cartridges and that the cartridges or tanks do not exceed a volume of 2 ml;

Note: Separately bought nicotine solution, which is commonly used in the mixing of ‘homemade’ DIY e-liquids and is often purchased in 7.2% concentration, is within scope of the TPD and its product restrictions including nicotine concentration (>2.0%) and container size (>10 ml).

(b)  the nicotine-containing liquid does not contain nicotine in excess of 20 mg/ml;

See guidance on tolerance level for nicotine concentration (label claim vs. actual content).

(c)  the nicotine-containing liquid does not contain additives listed in Article 7(6);

The EU Manufacturing standards, currently in development, shall align with this provision.  Additives in Article 7(6) include vitamins, caffeine, colourants and chemicals classed as carcinogens, mutagens or reprotoxins in unburnt form. 

(d)  only ingredients of high purity are used in the manufacture of the nicotine-containing liquid. Substances other than the ingredients referred to in point (b) of the second subparagraph of paragraph 2 of this Article are only present in the nicotine-containing liquid in trace levels, if such traces are technically unavoidable during manufacture;

‘Substances’ refers to heavy metals and other contaminants, the levels of which should be controlled in the finished product. 

(e)  except for nicotine, only ingredients are used in the nicotine-containing liquid that do not pose a risk to human health in heated or unheated form;

Permitted flavouring compounds may, in the future, be prohibited on new and emerging toxicological information.


Request a tox profile for notification purposes here


(f)  electronic cigarettes deliver the nicotine doses at consistent levels under normal conditions of use;

An indication of the emitted nicotine dose via laboratory testing (see TPD Testing) may be required on packaging in some EU markets along with the nicotine label claim.

(g)  electronic cigarettes and refill containers are child- and tamper-proof, are protected against breakage and leakage and have a mechanism that ensures refilling without leakage.”

Technical standards for refill mechanism and standards for child-resistant packaging for reclosable and non-reclosable packaging apply.  Notably, devices should have tanks that are child-resistant.

More on TPD Requirements: Read notes on paragraph 1 and 2