Definitions, regulatory framework and role of the Agency
Updated on 09/10/2018
Tobacco, Cigarette, Vaping product, Electronic cigarette, E-liquid, Nicotine, Additives, Flavourings, Toxicity reference values (TRVs), Addiction, Volatile organic compounds (VOC)
The Tobacco Products Directive (2014/40/EU) lays down rules relating to the manufacture, presentation and sale of tobacco and related products (other smoking products, vaping products). While it does not establish a marketing authorisation system, the Directive requires manufacturers and importers to declare these products to the competent authorities of the Member States before they can be marketed. Their composition, emissions, toxicological data on the ingredients, in-depth studies for certain additives and market data must be provided. As part of the transposition of this Directive into French law, ANSES has been tasked with collecting and analysing this information. This mission falls within the general framework of the Agency's health protection activities, especially the work carried out in the area of chemicals, consumer products and the risks associated with air quality.
Tobacco and related products are classified into three categories::
Tobacco products consist fully or partly of tobacco. They include cigarettes, roll-your-own tobacco, pipe tobacco, waterpipe tobacco, cigars, cigarillos, chewing tobacco, nasal tobacco (snuff), and new heat-not-burn tobacco products (HNB).
Vaping products are electronic "vaping" devices (electronic cigarettes), i.e. products for consuming nicotine-containing vapour, as well as the refill containers, i.e. receptacles filled with a nicotine-containing liquid, which can be used to refill an electronic vaping device.
Herbal products for smoking other than tobacco are based on plants, herbs or fruits. They contain no tobacco and can be consumed via a combustion process.
The Tobacco Products Directive (2014/40/EU), which came into force on 19 May 2014, has been applicable in the Member States of the European Union since 20 May 2016. It establishes rules relating to the manufacture, presentation and sale of tobacco and related products.
Before these products can be marketed on the territory of the European Union, their manufacturers and importers are required to declare them to the national authorities concerned. In France, the competent administrative authority is the Ministry of Health.
In application of these provisions, transposed into French law by Order No. 2016-623 of 19 May 2016 (in French), ANSES was tasked under the Ministerial Order of 22 August 2016 (in French) with collecting and analysing the information contained in these declarations. For these products, which are not subject to marketing authorisation, this expert appraisal mission aims to provide scientific and technical support to the competent authority. It is funded by fees paid by the organisations declaring the tobacco products and vaping products (in French).
The Agency's role: expert appraisal and information
In this context, ANSES is responsible for receiving, storing, processing and analysing the information submitted by these organisations on their products.
This mission involves scientific expert appraisal work to identify and assess the hazards of the chemicals to which consumers or those around them are exposed when these products are used. Besides tobacco, whose health effects are known, this concerns the ingredients and additives used in their composition, and especially the volatile compounds formed in the emissions that are inhaled. The Agency established a Working Group (WG) on "Tobacco and vaping products", reporting to its Expert Committee (CES) on "Assessment of chemical risks of consumer items and products", to help it conduct this expert appraisal work.
ANSES is also involved in the Joint Action on Tobacco Control (JATC), a project funded at European level by the 2014-2020 Health Programme and designed to support implementation of the Tobacco Products Directive by the Member States. The Agency is participating in various tasks for this project, including one relating to the analysis of toxicological data on the ingredients and additives in tobacco and vaping products.
Declarations to the authorities in each Member State concerned are made via a centralised computer system, set up by the European Commission and operational since May 2016. At this stage, the national entities only have secure access for consulting the product declarations. The Commission is gradually adding to the features of the consultation interface. The Agency is therefore gradually implementing its process to make available the information on the products as declared, which will be expanded as the features of the centralised information system are developed.
The files are available and can be downloaded from this page. They are updated regularly and enhanced as new features are added to the European database's consultation interface.
Public data (in French, Excel format)
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