Selecting the mandatory elements to be put on a hardware label is not a simple thing: many laws (TPD-II, directives specific for electrical and electronic equipment, Consumer Code, CLP…) and many product variables are involved. Let’s see together the main cases.
Devices sold individually, without e-liquid
Unit packets and any outside packaging of devices sold individually, without e-liquid, must include the following:
- commercial name/product description;
- components list;
- technical specifications;
- batch number;
- a recommendation to keep the product out of reach of children;
- disposal instruction;
- instructions for use or leaflet reference;
- country of origin, if located outside the EU;
- information on the potential presence of harmful substances to human health;
- data of the manufacturer / the importer (name, address and telephone number);
- in some Member States, health warning (having specific graphic requirements for font and size) is required; if your device does not contain e-liquid with nicotine when sold, a sentence like this must be added: ‘The health warning applies when the disposal/vaporizer/device contains nicotine e-liquid’;
- where applicable, the CE marking.
The label shall be in the official language of the Member State where the product is marketed. Some Member States require more than one language.
The device itself must be marked with:
- CE marking (where applicable, the CE marking may also appear on the sales packaging);
- the crossed-out wheeled bin symbol, as a designation of a different waste disposal for certain kinds of electrical appliances. In exceptional cases, where this is necessary because of the size or the function of the product, the symbol shall be printed on the packaging, on the instructions for use and on the warranty of the electrical and electronic equipment.
Both the symbols must be printed visibly, legibly and indelibly.
Device sold in combination with e-liquid
The unit packets and any external packaging of devices sold in combination with e-liquid must contain all the information listed previously.
In addition, if the e-liquid sold with the device contains nicotine, the unit packets and any external packaging must include also:
- list of ingredients above the 0,1% (weight/weight) in descending order of weight;
- nicotine content (in mg/ml);
- amount of nicotine delivered per dose (mg/10ml);
- signal words, pictograms and its relative warning, precautionary statements and tactile triangle, if the mixture is dangerous according to the CLP Regulation; please note that this applies also to 0 nicotine e-liquids classified as hazardous.
It is important to remember that in some States nicotine-free products are covered by TPD-II and thus they must be compliant with the same requirements of nicotine containing products .
Verification of compliance
Not so simple…moreover Member States may add specific requirements on labeling and additional national regulations. The regulatory framework can change rapidly and independently in each Member State.
It is also possible to put a series of non-mandatory elements that can be particularly appealing to consumers on unit packets and outside packaging; similarly, some information on packaging is forbidden.
It is therefore always advisable to carry out a professional check on the conformity of the labels, both for products already on the market and for launches in new national markets.
Packaging is in fact the first connection with consumers, but also with the control Authorities.
Contact us to check your labels or to design together those for new markets or new products.