Directive 2014/40/EU concerning the manufacture, presentation and sale of tobacco and related products came into force in May 2016. Manufacturers of tobacco and vaping products have since been required to report on the composition, emissions, toxicity and sales volumes of their products before marketing them. The Directive has also established a specific regulatory framework for electronic cigarettes and e-liquids containing nicotine. In France, ANSES has been designated to collect and analyse all information from manufacturers, and a roadmap has been drawn up for this purpose with the Directorate General for Health.
The manufacturers must provide comprehensive information on ingredients in, and emissions from, tobacco products and products used with electronic cigarettes in order to assess their attractiveness, addictiveness and toxicity, and improve knowledge of the risks to human health associated with the consumption of such products.
The Agency carried out an unprecedented overview of the types and composition of products sold on the French market
It also reviewed the information submitted since May 2016. Between May 2019 and June 2020, 3 173 tobacco products and 33 813 vaping products were reported to be sold on, or intended for, the French market.
These were mainly cigarettes, cigars and cigarillos, as well as e-liquids packaged in refill containers or cartridges. This review enabled ANSES to draw up a list of reported substances found in the products. More than 850 additives were referenced for tobacco products, while the first ever reference list for vaping products was drawn up, containing nearly 1,200 substances.
The tobacco products reported for the French market contained a varying number of additives. Cigars contained just one additive while an average of thirty were reported for cigarettes, and even more for pipe tobacco. The majority of additives were used as flavour or taste enhancers. These facilitate tobacco initiation by hiding its naturally acrid taste, and can also influence smoking habits. Under the European directive, manufacturers must provide in-depth studies on fifteen additives in cigarettes and roll-your-own tobacco, documenting their effects in terms of increased toxicity or addictiveness, increased nicotine inhalation and the forming of carcinogenic, mutagenic or reprotoxic substances. The studies submitted by manufacturers in mid-2018 are currently being evaluated by a group of European-level experts in particular.
Most e-liquids for vaping reported for the French market contained a diluting agent such as propylene glycol (PG) and/or glycerol (vegetable glycerine [VG]), had a mean nicotine content of approximately 6 mg/ml and could contain up to fifteen flavouring substances. The most common ones were derived from vanillin, maltol, menthol and esters with a fruity aroma.. Sugars and sweeteners (e.g. glucose/fructose and sucralose), acids used in nicotine salts and plant extracts were also found.
This analysis enabled ANSES to identify inconsistencies and non-conformities and notify them to the reporting companies
Information on product composition and especially on sales volumes was lacking, and several inconsistencies in the information submitted were also apparent. On the basis of the information reported, some less frequent non-conformities identified by the Agency included emissions above the regulatory threshold for certain cigarettes, and excessive nicotine content in some vaping products. Rare cases were also identified involving the reporting of prohibited substances, such as vitamins and carcinogenic, mutagenic and reprotoxic substances.
ANSES informed all the reporting companies concerned of the non-conformities identified and asked them to address the issues, either by taking steps on the products or the information reported in accordance with the European process. Non-compliant products require special attention from the authorities to ensure that they are no longer offered for sale.
Drawing on its expertise, the Agency will share its recommendations with the Commission and EU Member States to improve the reporting process, especially as part of its contribution as a partner to the Joint Action on Tobacco Control (JATC). This includes, for example, compiling a validated list of substances to avoid inconsistent information on ingredients or emissions being reported.
Data have been published to inform consumers
As part of its mission to inform the public, ANSES is publishing the list of reported products, along with their characteristics and composition, and any discrepancies identified in the information submitted, on its website ( tobacco data , vaping data ) and on data.gouv.fr. To date France is the first Member State to publish such detailed information on these marketed products.
Beyond regulatory compliance requirements, the current concern is the assessment of health risks associated with inhaling certain chemicals contained in vaping products and new heated tobacco products. Work on ranking the substances in question is under way as this is a prerequisite for any risk assessment process.