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The original protocol was approved by the FAF Panel on 17 January 2020 and it was originally published asEFSA supporting publication on 18 February 2020, as Annex of the Technical report. Outcome of the public consultation on a draft protocol for the assessment of hazard identification and characterisation of sweeteners. EFSA supporting publication 2020: EN-1803. 28 pp. doi:10.2903/sp.efsa.2020. EN-1803. During the implementation of this protocol, the following revisions and further elaborations were introduced: Section 1.4: a clarification on the key studies to consider in the risk assessment and evaluated according to the protocol was added, in order to take into account substances for which no health-based guidance value (HBGV) was derived. Section 1.6: it was specified that a more detailed approach for assessing the relevance and reliability of genotoxicity studies has been developed and is currently reported in Appendix B. Section 1.7.1: regarding human data, additional type of studies (e.g. studies with mixtures, studies on absorption of nutrients), not specified in the inclusion/exclusion criteria of Table 5, have been considered for inclusion, using either a narrative or systematic (i.e. risk of bias evaluation) approach. Section 1.7.2: regarding animal data, a clarification on how to consider studies performed with mixtures (specified, unspecified, commercial (trade) names) has been added. Additional type of studies (i.e. studies using animal disease models), not specified in the inclusion/exclusion criteria of Table 7, have been considered for inclusion using a narrative approach. Section 1.9: further details on a stepwise approach on which studies should be considered in the weight of evidence has been added, based on the outcome of the risk of bias (RoB) evaluation of key studies. Section 1.10: new calls for data more recently launched by EFSA have been added. Section 1.12: some changes regarding the selection of the key questions for RoB evaluation for human studies have been introduced. Tables on animal and human studies with the decision guiding the scoring for the different RoB questions are currently reported in Appendix C and D. In addition, some further considerations on studies evaluated as tier 3 have been added. Section 1.13: a revised version of the data extraction forms have been developed, including additional information/explanations on the different fields of the data extraction tables. Section 1.14: a more detailed description of the different steps of the weight of evidence analysis have been included. The approach has been further developed based on NTP-OHAT, 2019 with some modifications and adaptations. Section 1.16: some changes have been introduced in order to reflect how the uncertainties for the published opinions on sweeteners were addressed (i.e. Thaumatin (E 957), Neohesperidine dihydrochalcone (E 959)), for which few studies were available and it was thought to express uncertainties in a narrative way only).

The increasing worldwide interest in Lead-cooled Fast Reactors (LFRs) substantiates the need to validate the analytical codes and methods used to support their design. For neutronic analyses, this is chiefly reflected in assessing the impact of nuclear data uncertainties on the integral and local parameters resulting from such analyses. The aim of refining nuclear data moves continuous efforts for more accurate measurements, be them differential or integral, for which adequate facilities are required. The availability at the ENEA's Casaccia research center of a fast source reactor – RSV TAPIRO – provides a unique opportunity to perform new integral experiments in support of fast reactors, including LFRs, owing to the well-characterized neutron spectrum of the thermal column. A series of experiments has been envisaged, dealing with the use of Lead in a reactor. The experiments concern the propagation of neutrons through blocks of materials representing relevant elements of a reactor core, and ranging from pure Lead to mixtures reproducing portions of the reflector and shield in LFRs. The paper is focused on the feasibility study of some of these experiments in which Lead and mixture blocks are inserted in the so-called thermal column of the RSV TAPIRO reactor and irradiated by the neutron flux emerging from the Copper reflector surrounding the reactor core.

Dysfunction of the sympathetic nervous system underlies many cardiac diseases and can be assessed by molecular imaging using SPECT tracers as I-metaiodobenzylguanidine (I-MIBG). The norepinephrine analog C-meta-hydroxyephedrine (HED) has been used with PET to map the regional distribution of cardiac sympathetic neurons. Hydroxyephedrine is rapidly transported into sympathetic neurons by the norepinephrine transporter and stored in vesicles. This review describes the mechanism of action, radiosynthesis, and application of HED in the assessment of the cardiac sympathetic nervous system in heart failure, myocardial infarction, and arrhythmias. Noncardiac applications of HED in the clinical setting of sympathetic nervous system tumors and other emerging research applications are described

Introduction: The study evaluates the application of an onsite screening for the detection of illicit drugs in oral fluids with further confirmation analysis by LC/MS/MS, as rapid diagnostic tool in Emergency. Materials and Methods: Oral fluids were collected (by Cozart DDS oral swab) from 110 hospitalized patients at an Anti Poisons Centre, during 2009. Toxicological screening of oral fluid was performed using Cozart onsite immunoassay to reveal the presence of THC, Cocaine, Opiates, Amphetamine, Methamphetamine, BDZ and Methadone. All samples were confirmed by LC/MS/MS. As controls, oral fluid samples from 50 volunteers were analyzed. Results: Results obtained for patients by onsite immunoassay carried out on admission, were constantly confirmed by LC/MS/MS analyses except for THC (only 3 cases not confirmed). All controls from volunteers were negative as with Cozart as by LC/MS/MS. Data about drugs show that the poly drug use regards 38% of in-patients with higher incidence of cocaine/opiates and cocaine/THC association. Cocaine is also the main cause of acute intoxication and concerns, as a single drug taken, 27% of subjects. Conclusions: The results demonstrate that the oral fluid analysis, if rapidly applied on admission in Emergency Department, may lead to a significant improvement in clinical diagnosis and therapeutic management of acute intoxications involving illicit drugs abuse.

Background and Aims: We evaluated the usefulness of Positon Emission Tomography (PET) with two tracers, 11C-Acetate and 18FFluorodeoxyglucose (FDG), for differentiating focal nodular hyperplasia (FNH), that is managed conservatively, from hepatic adenoma (HA) that needs to be resected. Methods: We prospectively enrolled 30 patients with known or suspected FNH or HA. The diagnostic work-up included Doppler ultrasonography (US), contrast enhanced computed tomography (CT) and/or magnetic resonance imaging (MRI). Fine needle biopsy (FNB) was performed if imaging study was inconclusive. All patients underwent double tracer PET with a single day protocol. The images were acquired with a PET-CT tomograph to obtain image fusion. The tracer uptake was evaluated using the maximum standardized uptake value (SUVmax). The target to background (T/B) ratio was also calculated. Lesions

The so-called smart-drugs, plant-based substances used for centuries by diverse populations especially of Central America in strict ritualized shamanic context thanks to their psychotropic effects, from the nineties have had wide diffusion across Europe. In Italy smart-drugs business, by passing traditional clandestine labs and illicit channels, was possible by their availability in smart-shops appeared in Milan and Rome and moreover exploiting the ever-expanding internet system. Via the Internet avid surfers have found troublefree accessibility to smart-drugs at low cost with the advantage of difficulties in police control, anonymity and lack of regulations, too. In Italy, between 2001-2003, Postal Police has seized more than five hundred parcels containing suspicious botanical species and tablets sent after on-line purchases by a known Dutch Internet site to Italian buyers. The authors hereby present the results of toxicological analysis on these findings (1167), with evidence of active principles ascribable to different smart-drugs: salvinorine in Salvia divinorum; LSA (ergine) in seeds of Rivea corymbosa, Ipomea violacea, Argyreia nervosa, harmine and harmaline in Peganum harmala, mescaline in Lophophora Williamsii, psilocybin/psilocin in Copelandia Cyanescens, Psilocybe Tampanensis, Psilocybe Cubensis, Philosophers Stones, ephedrine and yohimbine in several pharmaceutical products. Considering smart-drugs an unknown hazard and a potential emerging drug of abuse we give a general overview of the possible psychoactive effects of the most widely used smart drugs in their various forms of intake and their possible harms on man. Furthermore we illustrate the most recent trade restrictions adopted in Italy to limit their diffusion via the Internet.

The management of chronic myeloid leukemia (CML) has changed radically since the introduction of imatinib therapy. The decision of whether to offer a patient a hematopoietic stem cell transplant (HSCT) must be based on the probability of success of the procedure. The aim of this retrospective analysis of 1,084 CML patients who received an allogeneic HSCT in 10 Brazilian Centers between February 1983 and March 2003 was to validate the EBMT risk score.The study population comprised 647 (60%) males and 437 (40%) females, with a median age of 32 years old (range 1 - 59); 898 (83%) were in chronic phase, 146 (13%) were in accelerated phase and 40 (4%) were in blast crisis; 151 (14%) were younger than 20 years old, 620 (57%) were between 20 and 40 and 313 (29%) were older than 40; 1,025 (94%) received an HLA fully matched sibling transplant and only 59 (6%) received an unrelated transplant. In 283 cases (26%) a male recipient received a graft from a female donor. The interval from diagnosis to transplantation was less than 12 months in 223 (21%) cases and greater in 861 (79%). The overall survival, disease-free survival, transplant-related mortality and relapse incidence were 49%, 50%, 45% and 25%, respectively.Of the 1084 patients, 179 (17%) had a risk score of 0 or 1, 397 (37%) had a score of 2, 345 (32%) had a score of 3, 135 (12%) had a score of 4 and 28 (2%) a score of 5 or 6. The overall survival (OS) rate in patients with risk scores 0-1 and 2 was similar (58% and 55%, respectively) but significantly better than that in patients with scores 3 or more (score 3 - 44%, 4 - 36 % and 5-6 - 27%, respectively) pp0.001). Disease-free survival (DFS) and transplant related mortality (TRM) in a patients with a score of 3 or more were 46% and 49%, respectively and the relapse rate beyond score 5-6 was 77%. Disease status had a negative impact on all outcomes (OS, DFS, TRM, and relapse). The OS rate for male recipients of a graft from a female donor was 40% compared to 52% among the other donor-recipient pairs (p=0.004). DFS and TRM were significant for disease phase and female donor-male recipient (p0.001 and p0.003, respectively). In our experience, age and interval between diagnosis and transplant did influence OS, DFS, TRM, and relapse rate.Our results validate the EBMT risk score in the context of a developing country and confirm its usefulness for making point decisions in the imatinib era.