Review of industry reports on EU priority tobacco additives part A: Main outcomes and conclusions

Anne Havermans (1) , Nadja Mallock (2) , Efthimios Zervas (3, 4) , Stéphanie Caillé-Garnier (5) , Thibault Mansuy (6) , Cécile Michel (6) , Jeroen L A Pennings (1) , Thomas Schulz (2) , Per E Schwarze (7, 8) , Renata Solimini (8) , Jean-Pol Tassin (9, 10) , Constantine I Vardavas (11) , Miguel Merino (12) , Charlotte G G M Pauwels (1) , Lotte E van Nierop (1) , Claude Lambré (13) , Anette K Bolling (7, 8)

1 RIVM - National Institute for Public Health and the Environment [Bilthoven]
2 BfR - German Federal Institute for Risk Assessment [Berlin]
3 Hellenic Open University [Patras]
4 Hellenic Thoracic Society
5 UB - Université de Bordeaux
6 DER - Direction de l'Evaluation des Risques
7 NIPH - Norwegian Institute of Public Health [Oslo]
8 ISS - Istituto Superiore di Sanità = National Institute of Health
9 UP1 - Université Paris 1 Panthéon-Sorbonne
10 NPS - Neuroscience Paris Seine
11 Hellenic Cancer Society
12 AGAPA - Andalusia Agency For Agriculture and Fisheries Development
13 INRS (Paris) - Institut national de recherche et de sécurité (Paris)

The European Union Tobacco Products Directive (EU TPD) mandates enhanced reporting obligations for tobacco manufacturers regarding 15 priority additives. Within the Joint Action on Tobacco Control (JATC), a review panel of independent experts was appointed for the scientific evaluation of the additive reports submitted by a consortium of 12 tobacco manufacturers. As required by the TPD, the reports were evaluated based on their comprehensiveness, methodology and conclusions. In addition, we evaluated the chemical, toxicological, addictive, inhalation facilitating and flavoring properties of the priority additives based on the submitted reports, supplemented by the panel's expert knowledge and some independent literature. The industry concluded that none of the additives is associated with concern. Due to significant methodological limitations, we question the scientific validity of these conclusions and conclude that they are not warranted. Our review demonstrates that many issues regarding toxicity, addictiveness and attractiveness of the additives have not been sufficiently addressed, and therefore concerns remain. For example, menthol facilitates inhalation by activation of the cooling receptor TRPM8. The addition of sorbitol and guar gum leads to a significant increase of aldehydes that may contribute to toxicity and addictiveness. Titanium dioxide particles (aerodynamic diameter <10 µm) are legally classified as carcinogenic when inhaled. For diacetyl no report was provided. Overall, the industry reports were not comprehensive, and the information presented provides an insufficient basis for the regulation of most additives. We, therefore, advise MS to consider alternative approaches such as the precautionary principle.

Mots clés: Tobacco additives; Toxicity; Addictiveness; Inhalation facilitation; Attractiveness; Tobacco regulation; Public Policy

Domaines: Sciences cognitives; Sciences du Vivant [q-bio]

Anne Havermans, Nadja Mallock, Efthimios Zervas, Stéphanie Caillé-Garnier, Thibault Mansuy, et al.. Review of industry reports on EU priority tobacco additives part A: Main outcomes and conclusions. Tobacco Prevention & Cessation, 2022, 8, pp.1 - 18. ⟨10.18332/tpc/151529⟩. ⟨hal-03807731⟩