The Tobacco Products Directive 2014/40/EU (TPD2) in its Article 6 calls upon the European Commission to develop and update a priority list of additives contained in cigarettes and roll-your-own tobacco by May 2016. Listed additives may contribute to the toxicity or addictiveness of the product, result in a characteristic flavour, facilitate inhalation or nicotine uptake, or lead to the formation of substances that are carcinogenic, mutagenic or reproductive toxins (CMR properties). SCENIHR has performed an extensive literature search of the most frequently used additives in tobacco products across hundreds of brands, and identified 48 priority chemicals and natural products.

Six substances were considered to be the “first priority”, as CM potential could not be ruled out (and according to TPD2, Member States should prohibit the placing on the market of tobacco products containing additives with CMR properties in the unburnt form):

  • diacetyl (there is uncertainty about the genotoxicity potential. There were no data on carcinogenicity).
  • 2-furfural (showed a co-carcinogenic effect with benzo[a]pyrene, present in cigarette smoke).
  • geraniol (may contain the impurity methyleugenol, a genotoxic carcinogen).
  • guaiacol (the only genotoxicity test on mammalian cells (SCE in human lymphocytes) gave positive results).
  • maltol (genotoxicity concern could not be ruled out)
  • titanium dioxide (classified as Group 2B (possibly carcinogenic to humans)).

Manufacturers or importers of cigarettes and roll-your-own tobacco containing a priority-list additive will have to carry out “comprehensive studies” evaluating whether these additives possess any such character.

SCENIHR (2016). Scientific Committee on Emerging and Newly Identified Health Risks. Final opinion on additives used in tobacco products (opinion 1) Tobacco Additives I. 25 January 2016. http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_051.pdf

 

The above items were taken from the March 2016 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)

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