Published on 10/11/2020
Tobacco, Cigarette, Vaping product, Electronic cigarette, E-liquid, Nicotine, Addiction
Under the regulations on tobacco and related products, ANSES is responsible for collecting and analysing the information reported by manufacturers on the products sold in France. As part of this work, the Agency is providing expert scientific support to the Directorate General for Health (DGS). It provides knowledge on the products placed on the French market, along with scientific intelligence on product composition. The Agency also conducts expert appraisals to assess the health risks associated with these products, which ties in with its other work on chemicals in consumer products and the health risks related to air quality. Overview of ANSES's responsibilities
What is meant by tobacco and related products?
Tobacco and related products fall 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 heated tobacco products.
- Vaping products consist of electronic "vaping" devices (electronic cigarettes), i.e. products for consuming nicotine-containing vapour, and 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 do not contain any tobacco and can be consumed via a combustion process.
The new European 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 on the manufacture, presentation and sale of tobacco and related products.
Before these products can be marketed within European Union borders, their manufacturers and importers are required to declare them to the relevant national authorities. Data to be provided include information on product composition and emissions, toxicological data on ingredients, in-depth studies for certain additives, and market data.
As part of the transposition of the European directive into French law, ANSES has been tasked with collecting and analysing this information. The process is not a marketing authorisation (MA) process, but a registration system based on the reporting of information before marketing can take place. ANSES cannot control the products on the market, nor can it enforce penalties for infringement of the regulations. Its role is rather to provides scientific and technical support to the French Ministry of Health, which is the competent authority in France for the implementation of the European directive.
The Agency's role: expert appraisal and information
In this context, ANSES is responsible for receiving, storing, processing and analysing the information submitted by manufacturers on their products. Its efforts to make most of the information reported accessible to the public are ground-breaking on a European scale.
ANSES’s mission to inform
The Agency is publishing a list of products sold on the French market that have been reported more than six months ago, along with detailed information on their characteristics and composition, within the limits of business secrecy. These data, which are updated monthly, now include an assessment of the quality of reported information, which highlights missing or inconsistent data, for example, and their compliance with regulatory requirements. This information will be supplemented and enhanced through new criteria, particularly criteria that have become available through expert appraisal work
Expert assessment tasks
These involve scientific expert appraisal work to identify and assess the risks associated with the chemicals to which consumers or those around them are exposed when these products are used. Besides the well-known health effects of tobacco smoke, the concern relates especially to the substances emitted when vaping products and new heated tobacco products are consumed. The main objectives of the expert appraisal work are to:
- improve our understanding of product composition, the ways in which products are used and the monitoring of supply and demand trends;
- measure the impact on consumer health;
- propose a strategy for monitoring and controlling product compliance.
For its expert assessment work, ANSES is supported by a working group of experts on “tobacco and vaping products”.
The fight against smoking
In France, ANSES’s action falls under the National Tobacco Control Programme 2018–2022 (PNLT). On a wider scale, the Agency is engaged in the Joint Action on Tobacco Control (JATC) project funded by the European Commission to harmonise implementation of the Directive across Member States.
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