Background The transposition of the New Tobacco Product Directive (TPD) 2014/40/UE in Italy entered into force in 2016. Main regulations were: Reporting obligations, ban of some ingredients and of some products with characterising flavours Pictorial warnings with Quitline number Sale ban of 10-cigarette packages Reporting obligations for new electronic-cigarettes (e-cigs); Advertising ban; child - and tamper - proof for refill containers. The transposition was an occasion to add new measures: Stricter enforcement of the sale ban to minors Smoking ban in cars with minors and pregnant women Smoking ban in outdoor areas of Pediatric and Gynecologic Departments Sale ban of e-cig and refill containers to minors Methods Presentation of the evaluation plan of the impact of the new TPD in Italy. Presentation of preliminary results for the year 2017. Results - The behavioural risk factor surveillance system PASSI, the ISTAT survey and the DOXA surveys on representative samples of Italians will allow us to study smoking and e-cigarette prevalence in adults; quitting attempts among smokers; the impact of pictorial warnings on smokers; second-hand smoke exposure in non-smokers; attitudes, perception, and behaviours of Italians after the coming into force of the new TPD; - The GYTS (Global Youth Tobacco Survey) will monitor smoking and e-cig prevalence, tobacco access and availability among Italian adolescents; - the National Institute of Health (ISS) will monitor the compliance with the smoking ban in cars, and the outdoor ban outside some Hospital Departments; - Temporal trend in Quitline calls will be studied. The impact of pictorial warnings will be also studied among smokers calling the Quitline, or attending Italian Smoking Cessation Centers; - The online transmission of ingredients of tobacco products from tobacco companies will be followed at the ISS. We will add preliminary results not yet produced. Conclusions The evaluation plan will allow to study all dimensions of the TPD impact.

Introduction The transposition of the New Tobacco Product Directive (TPD) 2014/40/UE in Italy - the law n.6/2016 - entered into force in 2016. This law contains all the TPD regulations, and other new measures: 1. Stricter enforcement of the tobacco sale ban to minors, with higher fines and withdrawal of the sell licence for tobacco retailers; 2. Smoking ban in cars with minors and pregnant women 3. Smoking ban in outdoor areas closed to Pediatric and Gynecologic Hospital Departments 4. Sale ban of e-cig and refill containers to minors. Main aim is to show the evaluation plan of the new TPD in Italy. Material and Methods Presentation of the different tools of the evaluation plan. Results - The behavioural risk factor PASSI, the ISTAT, and the DOXA surveys on representative samples of Italians, will allow to study smoking and e-cigarette prevalence in adults; quitting attempts among smokers; the impact of pictorial warnings on smokers; second-hand smoke exposure; attitudes, perception, and behaviours of Italians after the coming into force of the new law; - The GYTS will monitor smoking and e-cig prevalence, tobacco access and availability among adolescents aged 13-15 years; - the National Institute of Health (ISS), in collaboration with some Regional Health Departments in Italy, will monitor the compliance with the smoking ban in cars, and with the outdoor ban in hospitals; - Temporal trend in phone calls to the Italian Quitline will be monitored. Moreover, the impact of pictorial warnings will be studied among smokers calling the Italian Quitline, or attending Italian Smoking Cessation Centers. - The online acquisition and transmission of ingredients from tobacco companies will be followed at ISS. Conclusions This evaluation plan will allow to study all the dimensions of the impact of the TPD in Italy. Funding This study was funded by the Italian Ministry of Health (MADES project, chapter 4100/22).