Rappresentate Fiscale Autorizzato:
By Paciello M. (Foggia, Italia) on 10 Oct. 2019 :
By Manuel P. (Francavilla al Mare, Italia) on 14 Dec. 2018 :
The decree applies to vaping products, defined as:
« electronic cigarette: a product that can be used for consumption of nicotine-containing vapor via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. Electronic cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges»
« refill container: a receptacle that contains a nicotine-containing liquid, which can be used to refill an electronic cigarette»
a) name and address of the manufacturer, of the natural or legal responsible person within EU and, if applicable, of the EU importer;
b) a list of all ingredients contained in the product, and emissions resulting from the use of the product, by brand name and type, including quantities thereof;
c) toxicological data regarding the product’s ingredients and emissions, including when heated, referring in particular to their effects on the health of consumers when inhaled and taking into account, iter alia, any addictive effect;
d) information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions;
e) a description of the components of the product; including, where applicable, the opening and refill mechanism of the electronic cigarette or refill containers;
f) a description of the components of the production process, including whether it involves series production, and a declaration that the production process endures conformity with the requirements of this Article;
g) a declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably forseenable conditions.
The Ministries of Health and of Economy make the presented information available to the public on their institutional web sites, due regard being had to the protection of confidential business information.
Nicotine-containing electronic cigarettes or nicotine-containing refill containers must meet the following requirements:
a) are introduced onto the market:
1) in refill containers that do not exceed 10ml
2) in single-use electronic cigarettes with tanks that do not exceed 2 ml,
3)in single-use cartridges that do not exceed 2 ml,
b) nicotine concentration is not to exceed 20mg/ml.
c) eliquids are not to contain the following additives:
– vitamins or other additives that give the impression that a tobacco product benefits health or constitute a minor risk to health;
– caffeine or taurine or other additives and energy stimulants that have a connotation of energy and vitality;
– coloring additives for emissions
– additives that have CMR proprieties in unburnt form
d) must be made of high-purity ingredients only
e) except for nicotine, only ingredients that do not pose a risk to human health in heated or unheated form may be used.
Electronic cigarettes must deliver nicotine doses at consistent levels under normal conditions of use.
Electronic cigarettes and refill containers must be child- and tamper-proof, protected against breakage and leakage and must have a mechanism that ensures refilling without leakage.
Unit packets of electronic cigarettes and refill containers must include a leaflet detailing:
a) instructions for use and storage of the product, including a reference that the product is not recommended for use by young people and non-smokers.
c) warnings for specific risk groups;
d) possible adverse effects;
e) addictiveness and toxicity;
f) contact details of the manufacturer or importer and a legal or natural contact person within the Union.
Unit packets and outside packaging/labeling of electronic cigarettes and refill containers:
a) include a list of all ingredients contained in the product in descending order of the weight and an indication of the nicotine content of the product and the delivery per dose, the batch number and a recommendation to keep the product out of reach of children;
b) do not include elements and caractheristics listed as follows:
– imply that a certain product has revitalizing, energizing, healing, rejuvenating, natural, biological properties, o delivers other benefits to health or to lifestyle;
– resemble a food or a cosmetic product.
c) Should contain a health warning label: “Not to be used by non-smokers.” The warning should be displayed on two largest surfaces of a unit packet and of the outside packaging and it must cover 30% of the surfaces of the unit packet and of the outside packaging.
ITALY: Until the 20th of May 2017 the retail sale is allowed, to public and to retailers, of non compliant products. After the 20th of May 2017 the retailers will only be allowed to purchase from manufacturers or importers that have notified the articles in accordance with the TPD directive.
SLOVENIA: From the 11th of March 2017 on the resellers will be allowed to purchase from manufacturers or importers that have notified the articles in accordance with the TPD directive.
GREECE: From the 1st of March 2017 the resellers the resellers will be allowed to purchase from manufacturers or importers that have notified the articles in accordance with the TPD directive.
CROATIA: The directive has not been implemented yet.