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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 Istituto Superiore di Sanità (ISS, the National Institute of Health of Italy) and the Istituto dei Motori (IM) of the Consiglio Nazionale delle Ricerche (CNR, National Research Council) have carried out this study, jointly funded by the two institutes together with the Ministry of Environment. The chemical and toxicological characteristics of emissions from two urban bus engines were studied: a diesel engine fueled with both diesel oil and biodiesel blend and an equivalent spark-ignition one fuelled with compressed natural gas, operating in steady-state conditions. Regulated and unregulated pollutants, such as carcinogenic polycyclic aromatic hydrocarbons and nitrated derivatives, carbonyl compounds and light aromatic hydrocarbons were quantified. Mutagenicity of the emissions was evaluated by the Salmonella typhimurium/mammalian microsome assay. The effect of the fuels under study on the size distribution of particulate matter was also evaluated. The impact of diesel-powered transport on urban air quality, and the potential benefits for human health deriving from the use of natural gas for public transport, are discussed.

Le emissioni autoveicolari contribuiscono in maniera significativa all’inquinamento urbano e rappresentano un serio rischio per la salute umana, tanto che la IARC (IARC, 1989) ha classificato le emissioni diesel nel gruppo 2A (probabile cancerogeno umano) e le emissioni da autoveicoli a benzina nel gruppo 2B (possibile cancerogeno umano). In particolare, i motori diesel sono tra le sorgenti principali di particelle fini nelle aree urbane. Queste particelle si depositano facilmente nel tratto respiratorio e possono fungere da iniziatori di tumori polmonari o provocare altre malattie dell’apparato respiratorio (USEPA, 2002; Health Effects Institute, 2002). Il articolato proveniente da emissioni autoveicolari è costituito da una matrice solida carboniosa sulla quale sono adsorbiti centinaia di composti tossici, molti dei quali presentano attività mutagena e/o cancerogena. Fra questi, particolare rilevanza tossicologica hanno gli idrocarburi policiclici aromatici (IPA) e i loro derivati nitrati (Nitro-IPA), la cui presenza nelle emissioni è stata correlata con il combustibile usato e con la tecnologia motoristica impiegata (Concawe, 1998; Westerholm, 1994). Poiché la maggior parte degli autobus destinati al trasporto pubblico urbano è dotata di motori diesel, l’emissione di particolato avviene in aree densamente popolate, contribuendo significativamente all’esposizione della popolazione generale. Specificamente esposte alle emissioni risultano anche le categorie dei lavoratori impiegati sulle strade a tutela della disciplina del traffico, come ad esempio gli agenti di polizia municipale e di polizia stradale.

Immunoglobulins G (lgG) specific for benzo[a]pyrene-DNA adducts were elicited in Swiss mice by repeated subcutaneous injections of a high molecular weight benzo[a]pyrene-DNA conjugate-adjuvant mix. The immunization procedure resulted in the production of specific antibodies against adducted benzo[a]pyrene B[a]P in all treated animals. One week after completion of the immunization procedure, groups of ten immunized and ten non immunized female mice were treated by single intraperitoneal injection with two different doses of B[a]P. The mice were sacrificed 48 hours after treatment, and both liver and bone marrow cells were isolated for subsequent determinations of DNA binding and micronucleus induction, respectively. Covalent benzo[a]pyrene adducts in liver DNA were detected by competitive ELISA and the incidence of micronucleated polychromatic erythrocytes was evaluated by scoring one thousand cells per animal. The determination of DNA adducts in liver revealed significantly (p0.05) lower levels of B[a]P adducts in immunized mice compared to non-immunized animals at both doses, whereas no significant difference was observed between controls. Administration of benzo[a]pyrene produced moderate, dose-related increases in the incidence of micronucleated polychromatic erythrocytes in all treated groups, with no significant difference between immunized and non-immunized mice. The decrease of covalent DNA adducts in the liver of immunized mice suggests that the specific humoral immunity elicited by repeated carcinogen exposure may act as a relevant modulating factor in chemical carcinogenesis.

Natural gas has a favorable effect on both the engine performance and emissions. The heavy-duty vehicles fueled with natural gas have very low emission levels, not easily obtainable with other fuels, and therefore they are considered the most practicable EEV (Enhanced Environmental Friendly Vehicles). Moreover, the assessment of fuel availability makes its use possible for a long time, whilst the new generation of feeding systems offers solutions to the problem of fuel composition variability. Nevertheless, the positive environmental aspects often are not totally known by people involved in natural gas application, therefore some limitations in the diffusion of this fuel in the transportation sector still appear. This paper refers about the activities, under development at the Istituto Motori, aimed to evaluate the toxicity of engine exhausts gas, based on the analysis of components harmful to human health, such as the carbonyl compounds, PAHs and particulate matter. A research program to determinate the toxicity of the emissions of bus engines when fueled with natural gas and with diesel oil, pure or mixed with fuel from vegetable oil, was jointly planned by the Istituto Motori and the Istituto Superiore di Sanit\ab (Italian National Institute of Health). The activity was co-funded by the two institutes together with the Italian Ministry of Environment. This study is now in progress, its design is illustrated and the first results are presented.

Exposure to gasoline vapors is classified by the International Agency for Research on Cancer as possibly carcinogenic to humans, mainly on the basis of the established carcinogenicity of some component chemicals such as benzene. The mechanism of benzene toxicity, particularly its leukemogenic effects, is far from being fully understood. Different studies, aimed at evaluating the risk associated with exposure to benzene through fuels and coordinated by the Istituto Superiore di Sanità, are in progress in Italy. In an environmental monitoring survey on a sample of 111 service stations, conducted in Rome (Italy) in 1992, average yearly personal exposure to benzene, toluene and xylenes were estimated. Chemical determination of benzene and methylbenzene was carried out by GL-gas chromatography. From a sample of 27 service stations 34 fuel samples were collected, and their benzene content was measured by hr-gas chromatography. Subgroups of the filling station attendants undergoing the exposure assessment study, were included in biological monitoring surveys of early indicators of genotoxicity. In particular, 65 subjects were enrolled in a study aimed at evaluating the urinary concentrations of 8-hydroxydeoxyguanosine (8-OHdG), a biological marker of oxidative DNA damage, and 23 filling station attendants were selected for a survey of the frequencies of sister chromatid exchanges (SCE) and micronuclei (MN) in peripheral T lymphocytes. In the exposure assessment survey levels of 0.53, 0.71 e 0.32 mg/m3 in the average yearly personal exposure to benzene, toluene and xylenes, respectively, were estimated (individual means based on 6.5 repeated samples per employee). The daily quantities of super premium gasoline sold proved to be associated with the average yearly personal exposure to benzene, and current smokers showed a significantly lower exposure intensity compared with non-smokers. Among the latter, an increase of 0.11 ln mg/m3 in benzene exposure per unit increase (100 l) in gasoline sold (p0.001) was estimated by a multiple regression analysis with some personal characteristics of the subjects included in the model as potentially predictive variables (R2 = 0.17, p (F)0.05). Among smokers, however, only the age and the length of employment were able to predict the intensity of benzene exposure. On a sample of 27 filling station attendants, furthermore, the relationship between personal exposure to benzene and benzene fuel content was evaluated and an increase of 0.01 mg/m3 in the personal benzene exposure per unit increase (100 g) in the absolute quantity of benzene in the fuel sold was estimated (p0.0001, R2 = 0.50).(ABSTRACT TRUNCATED AT 400 WORDS)

Sixty-five commercial samples of natural flavouring substances were screened for mutagenicity in the Salmonella typhimurium strains TA98 and TA100. The results obtained demonstrated a significant mutagenic activity in onion and garlic extracts, both in assays with and without exogenous metabolic activation. The response pattern obtained in tester strains with different genetic backgrounds suggests the involvement of mutagenic flavone(s) in the genotoxic effects observed.