Tobacco products and related products, what are we talking about?
Tobacco and related products are classified into three categories:
- tobacco products are composed, even partially, of tobacco. They include cigarettes, rolling tobacco, pipe tobacco, waterpipe tobacco, cigars, cigarillos, chewing tobacco, snuff and new heated tobacco products;
- vaping products are electronic vaping devices, i.e. products for the consumption of vapor containing nicotine, as well as refill bottles, i.e. containers containing a liquid containing nicotine, that can be used to recharge an electronic vaping device;
- herbal smoking products products other than tobacco are products made from plants, aromatic plants or fruits, which do not contain tobacco and which can be consumed by means of a combustion process.
The regulatory framework
The new European Tobacco Products Directive (2014/40/EU), which entered into force on May 19, 2014, has been applicable in the Member States of the European Union since May 20, 2016. It establishes rules concerning the manufacture, presentation and sale of tobacco products and related products.
Before marketing these products on the territory of the European Union, manufacturers and importers are required to declare them to the national authorities concerned. A number of data must be transmitted concerning: composition, emissions, toxicological data on ingredients, in-depth studies for certain additives as well as market data.
> Learn more about EU tobacco product regulations.
As part of the transposition of the European directive at French level, ANSES was appointed to collect and analyze this information. It is not a marketing authorization process (MA) but a declarative registration system before any marketing. ANSES has no power to control products on the market or impose penalties in the event of a breach of the regulations. It provides scientific and technical support to the Ministry responsible for Health which, in France, is the competent authority for the implementation of this European directive.
The role of the Agency: expertise and information
ANSES is responsible for receiving, storing, processing and analyzing the information submitted by the declarants on their products. In this context, it is a pioneer at European level in terms of making a large part of this information from declarations available to the public.
A fact-finding mission
The Agency makes public the list of products marketed on the French market declared more than six months ago, as well as a large amount of information on their characteristics and their composition, within the limits of business secrecy. These data, updated monthly, are now accompanied by an assessment of the quality of the data in the declaration file (missing data, inconsistent data, etc.) and their compliance with regulatory requirements. This information will be expanded and enriched with new criteria, in particular those resulting from expert appraisals.