The TPD - know the rules imposed and future rules on tobacco products
The TPD (Tobacco Products Directive) regulates vape products as tobacco products by imposing specific regulations on member countries. Each member country then transposes this European regulatory framework into its own legislation.
What are the legal bases of the TPD?
On 3 April 2014, the European Commission publishes the Tobacco Products Directive n°2014/40/EU, which sets out rules on the manufacture, presentation and sale of tobacco and related products. Without introducing a marketing authorisation system, the directive requires manufacturers and importers to declare these products to the competent authorities of the Member States before they are marketed. Composition, emissions, toxicological data on ingredients, in-depth studies for certain additives as well as market data must be provided. It prohibits sales to minors and advertising. It also sets out the packaging and information requirements in European territories.
The TPD was transposed into French law on 19 May 2016 by Order No. 2016-623.
What are the rules imposed by the TPD?
The TPD rules on product characteristics in European territories
The capacity of a bottle of nicotined e-liquid is limited to 10 ml. Its nicotine content must be less than or equal to 20 mg/ml. The bottle must have a tamper-proof safety device and be protected against breakage and leakage.
The name of the e-liquid must no longer contain the word "Tobacco" or refer to tobacco. This has led manufacturers to replace this word with the term "Classic" (Classic blond = blond tobacco).
For disposable tanks and cartridges pre-filled with nicotine e-liquid, the maximum capacity is set at 2 ml.
TPD rules on packaging:
The bottle of an e-liquid must mention the following information:
- the composition of the e-liquid containing nicotine ;
- the average nicotine content and the quantity dispensed per dose;
- the batch number;
- a recommendation that the product should be kept out of reach of children;
- a health warning: "The nicotine contained in this product is highly addictive. Its use by non-smokers is not recommended".
A leaflet containing the following information must also accompany the e-liquid
- instructions for use and storage of the product
- warnings for specific risk groups
- undesirable effects;
- addictive effect and toxicity;
- contact details of the manufacturer or importer.
TPD rules on quality control of e-liquids
In France, manufacturers and importers must submit a marketing notification file to the ANSES (National Agency for Food, Environmental and Occupational Health Safety) 6 months before the nicotine e-liquid is put on sale. This file must contain, in particular, the composition, the toxicological data of the ingredients and emissions or the manufacturing process of the product.
Finally, the TPD prohibits direct or indirect propaganda or advertising in favour of vaping products.