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TPD TRANSPOSITION IN ITALY

DIRECTIVE 2014/40/UE AND TRANSPOSITION IN ITALY

LEGISLATIVE DECREE OF 12 JANUARY 2016, N. 6

The DIRECTIVE 2014/40 / EU (TPD: Tobacco Products Directive) of the European Parliament and of the Council of European Union of 3 April 2014 regulates at EU level the manufacture, presentation and sale of tobacco products and related products.

 

The Article 20 is entirely dedicated to electronic cigarettes, imposing obligations to which producers and importers have to fulfill in order to be able to market their products within the Member States of the European Union. The TPD applies to hardware and nicotine containing refill liquids.

It does not apply to non-nicotine containing refill liquids and to hardware sold with them. Since it is a Directive, each EU member state will have to transpose it at the national level. In Italy, the Directive has been transposed with the Legislative Decree of January, 12 2016 (6) (D.Lgs. 6/2016) and the competent reference competent authority is the Ministry of Health.

 

REQUIREMENTS FOR ELECTRONIC SIGARETTES AND NICOTINE CONTAINING REFILL LIQUIDS (D.Lgs. 6/2016 )

 

Manufacturers and importers of electronic cigarettes and nicotine containing refill liquids must submit a notification to the competent authorities of Member States of any such product they intend to place on the national market concerned. The notification shall be submitted in electronic form six months before the intended placing on the market.

 

The EC is in charge, through the European Portal EU-CEG, to transmit the notified data to Member States declared among the markets of interest (in Italy to the Ministry of Health).

 

For electronic cigarettes and nicotine containing refill liquids already placed on the market on May 20, 2016, the notification is submitted within six months of that date (within November 20, 2016). On the base of on this pre-requisite, these products that have been successfully notified within the deadline, will be continuously maintained on the market as exemption.

Non compliant products, only if they have a production line batch prior to November 20, 2016, can remain in store and in the supply chain no later than May 20, 2017. A new notification shall be submitted for each substantial modification of the product.

 

NOTIFICATION FEE:

not yet established

ANNUAL FEE

not yet established

 

nicotine containing refill liquids

Nicotine containing liquids:

  • is only placed on the market in dedicated refill containers not exceeding a volume of 10 ml;
  • is only placed on the market in disposable electronic cigarettes or in single use cartridges and that the cartridges or tanks do not exceed a volume of 2 ml;
  • does not contain nicotine in excess of 20 mg/ml;
  • does not contain the following additives:
  • vitamins or other additives that create the impression that a tobacco product has a health benefit or presents reduced health risks;
  • caffeine or taurine or other additives and stimulant compounds that are associated with energy and vitality;
  • additives having colouring properties for emissions;
  • additives that have CMR properties in unburnt form.
  • are manufactured with only high purity ingredients
  • are manufactured with only ingredients, except for nicotine, that do not pose a risk to human health in heated or unheated form;

Electronic cigarettes and nicotine containing refill liquids are child- and tamper- proof, are protected against breakage and leakage and have a mechanism that ensures refilling without leakage.

 

LEAFLET

Unit packets of electronic cigarettes and nicotine containing refill liquids include a leaflet with information on:

  • 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;
  • contra-indications;
  • warnings for specific risk groups;
  • possible adverse effects;
  • addictiveness and toxicity;
  • contact details of the manufacturer or importer and a legal or natural contact person within the Union

 

unit packets and any outside packaging

Unit packets and any outside packaging of electronic cigarettes and nicotine containing refill liquids include:

  • list of all ingredients contained in the product in descending order of the weight
  • an indication of the nicotine content of the product
  • the delivery per dose
  • the batch number
  • a recommendation to keep the product out of reach of children;
  • the following health warning: «Prodotto contenente nicotina, sostanza che crea un'elevata dipendenza. Uso sconsigliato ai non fumatori.»

 

The labelling of unit packets and any outside packaging of electronic cigarettes and nicotine containing refill liquids shall not include any element or feature that:

  • suggests that a particular tobacco product is less harmful than others or aims to reduce the effect of some harmful components of smoke or has vitalising, energetic, healing, rejuvenating, natural, organic properties or has other health or lifestyle benefits
  • resembles a food or a cosmetic product
  • suggests that a certain tobacco product has improved biodegradability or other environmental advantages

 

The labelling of unit packets and any outside packaging of electronic cigarettes and nicotine containing refill liquids must also include CLP (Classification, Labeling and Packaging) classification requirements. The European CLP Regulation n ° 1272/2008 imposes as from June 1, 2015 the classification, labeling and packaging of mixtures containing hazardous substances.

 

SALES AND CROSS-BORDER DISTANCE SALES

The sale of electronic cigarettes and nicotine containing refill liquids is not permitted under the age of 18. The cross-border distance sales of electronic cigarettes and refill containers is not permitted.

 

ADVERTISING, PROMOTION, PUBLIC USAGE

Commercial communications for the promotion of electronic cigarettes and/or refill containers is prohibited. The use of electronic cigarettes in public places (except for schools) are allowed.

 

 

 

For any further information please contact:

 

Il nostro lavoro per rendere un prodotto conforme alla TPD-II

In breve

1
RICHIESTA INFORMAZIONI SULLA SOCIETà E SUI PRODOTTI

per conoscere la società e i prodotti vi chiederemo di compilare un modulo dedicato. Seguirà la stipula di un accordo di segretezza e di un preventivo.

2
RICEZIONE DEI CAMPIONI E REGISTRAZIONE DELLA VOSTRA SOCIETA’ PRESSO IL PORTALE EU-CEG

controlleremo che tutto sia in ordine per poter iniziare il processo operativo e richiederemo per vostro conto il Submitter ID alla Commissione Europea.

3
RICERCA BIBLIOGRAFICA TOSSICOLOGICA

e successiva redazione di un report di valutazione del rischio per ogni ingrediente. Svilupperemo un pacchetto di analisi in linea con le vostre necessità.

4
ANALISI DELLE EMISSIONI

e conseguente redazione di un report analitico. Parametri e condizioni saranno stabilite in funzione del prodotto e delle normative vigenti nei mercati di destinazione.

5
VERIFICA DELLA CONFORMITÀ DEI PRODOTTI

verificheremo che i vostri prodotti siano conformi alla normative. In caso contrario valuteremo sinergicamente come poter ottenere la conformità.

6
REDAZIONE DI UN DOSSIER TECNICO COMPLETO

mediante la valutazione integrata di informazioni provenienti dal produttore, dai laboratori di prova e dalla valutazione del rischio tossicologico.

7
NOTIFICA

attraverso il portale predisposto dalla Commissione che consentirà di ricevere l’EC-ID necessario per vendere nel territorio della UE.