42 results on '"Rossi, Annamaria"'
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2. Scientific Opinion on additional scientific data related to the safety of preparations of Rheum palmatum L., Rheum officinale Baill. and their hybrids, Rhamnus purshiana DC., Rhamnus frangula L. and Cassia senna L., submitted pursuant to Article 8(4) of Regulation (EC) No 1925/2006
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Knutsen, Helle Katrine, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Rossi, AnnaMaria, Titz, Ariane, Fiolet, Thibault, and Maciuk, Alexandre
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CASSIA (Genus) ,GENETIC toxicology ,SCIENCE publishing ,ANIMAL industry ,SAFETY ,IN vivo studies ,NUTRITION - Abstract
The Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the safety of plant preparations from the root or rhizome of Rheum palmatum L., Rheum officinale Baill. and their hybrids, from the bark of Rhamnus frangula L. and Rhamnus purshiana DC. and from the leaf or fruit of Cassia senna L., which have been placed under Union scrutiny in Part C of Annex III in accordance with Article 8(4) of Regulation (EC) No 1925/2006. The NDA Panel reviewed the additional scientific data submitted during the period of scrutiny and the public consultation by interested parties. The pertinent scientific data were in vitro and in vivo genotoxicity studies on the plant preparations under consideration. All the results of the genotoxicity studies on plant preparations were negative. However, the plant preparations that were tested in the submitted studies were not sufficiently characterised with respect to the content of total and individual hydroxyanthracene derivatives (HADs) and components other than HADs. The studies confirmed the presence of ■■■■■, known to be genotoxic in vivo, and ■■■■■, shown to be genotoxic in vitro. In line with the EFSA Scientific Committee statement on genotoxicity assessment of chemical mixtures, considering the presence of an in vivo genotoxic compound, the plant preparations used in these studies have to be considered of concern for genotoxicity. Thus, the safety of preparations containing HADs from the root or rhizome of Rheum palmatum L., Rheum officinale Baill. and their hybrids, from the leaf or fruit of Cassia senna L. and from the bark of Rhamnus frangula L. and Rhamnus purshiana DC. cannot be established based on the submitted studies. [ABSTRACT FROM AUTHOR]
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- 2024
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3. Contamination of Hotel Water Distribution Systems by Legionella Species: Environmental Surveillance in Campania Region, South Italy
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Di Onofrio, Valeria, primary, Pagano, Mariangela, additional, Santulli, Marco, additional, Rossi, Annamaria, additional, Liguori, Renato, additional, Di Dio, Mirella, additional, and Liguori, Giorgio, additional
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- 2023
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4. Crossing Experiences in Digital Epigraphy: From Practice to Discipline
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Irene Rossi, Annamaria De Santis
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- 2018
5. Statement on safety of cannabidiol as a novel food: data gaps and uncertainties
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch-Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, Neuhaeuser-Berthold, Monika, Poulsen, Morten, Maradona, Miguel Prieto, Schlatter, Josef Rudolf, Trezza, Viviana, van Loveren, Henk, Albert, Oceane, Dumas, Celine, Germini, Andrea, Gelbmann, Wolfgang, Kass, Georges, Kouloura, Eirini, Fernandez, Estefania Noriega, Rossi, Annamaria, Knutsen, Helle Katrine, Nutr Novel Foods Food, EFSA Panel, Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch-Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, Mcardle, Harry J, Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Frenzel, Thoma, Heinonen, Marina, Marchelli, Rosangela, Neuhäuser-Berthold, Monika, Poulsen, Morten, Prieto Maradona, Miguel, Schlatter, Josef Rudolf, Trezza, Viviana, van Loveren, Henk, Albert, Océane, Dumas, Céline, Germini, Andrea, Gelbmann, Wolfgang, Kass, George, Kouloura, Eirini, Noriega Fernandez, Estefania, Rossi, Annamaria, and Knutsen, Helle Katrine
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Agriculture and Food Sciences ,safety ,Veterinary (miscellaneous) ,REPRODUCTIVE FUNCTIONS ,data gaps ,Cannabidiol ,Novel Food ,Plant Science ,IMPAIRMENTS ,CANNABINOID EXPOSURE ,Microbiology ,ENDOCANNABINOID SYSTEM ,RECEPTOR AGONISTS ,EXPOSURE INFLUENCES NEUROENDOCRINE ,DOUBLE-BLIND ,data gap ,Medicine and Health Sciences ,Animal Science and Zoology ,Parasitology ,SEIZURES ,MOTOR ,MALE-MICE ,Food Science ,ORAL CANNABIDIOL - Abstract
The European Commission has determined that cannabidiol (CBD) can be considered as a novel food (NF), and currently, 19 applications are under assessment at EFSA. While assessing these, it has become clear that there are knowledge gaps that need to be addressed before a conclusion on the safety of CBD can be reached. Consequently, EFSA has issued this statement, summarising the state of knowledge on the safety of CBD consumption and highlighting areas where more data are needed. Literature searches for both animal and human studies have been conducted to identify safety concerns. Many human studies have been carried out with Epidyolex(R), a CBD drug authorised to treat refractory epilepsies. In the context of medical conditions, adverse effects are tolerated if the benefit outweighs the adverse effect. This is, however, not acceptable when considering CBD as a NF. Furthermore, most of the human data referred to in the CBD applications investigated the efficacy of Epidyolex (or CBD) at therapeutic doses. No NOAEL could be identified from these studies. Given the complexity and importance of CBD receptors and pathways, interactions need to be taken into account when considering CBD as a NF. The effects on drug metabolism need to be clarified. Toxicokinetics in different matrices, the half-life and accumulation need to be examined. The effect of CBD on liver, gastrointestinal tract, endocrine system, nervous system and on psychological function needs to be clarified. Studies in animals show significant reproductive toxicity, and the extent to which this occurs in humans generally and in women of child-bearing age specifically needs to be assessed. Considering the significant uncertainties and data gaps, the Panel concludes that the safety of CBD as a NF cannot currently be established.
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- 2022
6. A generic operational strategy to qualify translational safety biomarkers
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Matheis, Katja, Laurie, David, Andriamandroso, Christiane, Arber, Nadir, Badimon, Lina, Benain, Xavier, Bendjama, Kaïdre, Clavier, Isabelle, Colman, Peter, Firat, Hüseyin, Goepfert, Jens, Hall, Steve, Joos, Thomas, Kraus, Sarah, Kretschmer, Axel, Merz, Michael, Padro, Teresa, Planatscher, Hannes, Rossi, Annamaria, Schneiderhan-Marra, Nicole, Schuppe-Koistinen, Ina, Thomann, Peter, Vidal, Jean-Marc, and Molac, Béatrice
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- 2011
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7. Guidance on aneugenicity assessment
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EFSA Scientific Committee (SC), More, Simon John, Bampidis, Vasileios, Bragard, Claude, Halldorsson, Thorhallur Ingi, Hernández-Jerez, Antonio F, Hougaard Bennekou, Susanne, Koutsoumanis, Kostas, Lambré, Claude, Machera, Kyriaki, Naegeli, Hanspeter, Nielsen, Søren Saxmose, Schlatter, Josef, Schrenk, Dieter, Turck, Dominique, Younes, Maged, Aquilina, Gabriele, Bignami, Margherita, Bolognesi, Claudia, Crebelli, Riccardo, Gürtler, Rainer, Marcon, Francesca, Nielsen, Elsa, Vleminckx, Christiane, Carfì, Maria, Martino, Carla, Maurici, Daniela, Parra Morte, Juan, Rossi, Annamaria, Benford, Diane, and University of Zurich
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Veterinary (miscellaneous) ,Aneugenicity ,2405 Parasitology ,TP1-1185 ,Genotoxicity in vivo and in vitro ,Plant Science ,Gene mutation ,Bioinformatics ,Microbiology ,Clastogen ,In vitro ,Micronucleus test ,1110 Plant Science ,In vivo ,medicine ,TX341-641 ,1106 Food Science ,Nutrition. Foods and food supply ,business.industry ,Chemical technology ,Cros1223 ,genotoxicity in vivo and in vitro ,2404 Microbiology ,10079 Institute of Veterinary Pharmacology and Toxicology ,aneugenicity ,3401 Veterinary (miscellaneous) ,micronucleus test ,Scientific Opinion ,medicine.anatomical_structure ,570 Life sciences ,biology ,Animal Science and Zoology ,Parasitology ,Bone marrow ,1103 Animal Science and Zoology ,Genotoxicity ,business ,Risk assessment ,Food Science - Abstract
The EFSA Scientific Committee was asked to provide guidance on the most appropriate in vivo tests to follow up on positive in vitro results for aneugenicity, and on the approach to risk assessment for substances that are aneugenic but not clastogenic nor causing gene mutations. The Scientific Committee confirmed that the preferred approach is to perform an in vivo mammalian erythrocyte micronucleus test with a relevant route of administration. If this is positive, it demonstrates that the substance is aneugenic in vivo. A negative result with evidence that the bone marrow is exposed to the test substance supports a conclusion that aneugenic activity is not expressed in vivo. If there is no evidence of exposure to the bone marrow, a negative result is viewed as inconclusive and further studies are required. The liver micronucleus assay, even though not yet fully validated, can provide supporting information for substances that are aneugenic following metabolic activation. The gastrointestinal micronucleus test, conversely, to be further developed, may help to assess aneugenic potential at the initial site of contact for substances that are aneugenic in vitro without metabolic activation. Based on the evidence in relation to mechanisms of aneugenicity, the Scientific Committee concluded that, in principle, health‐based guidance values can be established for substances that are aneugenic but not clastogenic nor causing gene mutations, provided that a comprehensive toxicological database is available. For situations in which the toxicological database is not sufficient to establish health‐based guidance values, some approaches to risk assessment are proposed. The Scientific Committee recommends further development of the gastrointestinal micronucleus test, and research to improve the understanding of aneugenicity to support risk assessment., This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6814/full
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- 2021
8. Guidance on aneugenicity assessment
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EFSA Scientific Committee, More, Simon John, Bampidis, Vasileios, Bragard, Claude, Halldorsson, Thorhallur Ingi, Hernández-Jerez, Antonio F, Hougaard Bennekou, Susanne, Koutsoumanis, Kostas, Lambré, Claude, Machera, Kyriaki, Naegeli, Hanspeter, Nielsen, Søren Saxmose, Schlatter, Josef, Schrenk, Dieter, Turck, Dominique, Younes, Maged, Aquilina, Gabriele, Bignami, Margherita, Bolognesi, Claudia, Crebelli, Riccardo, Gürtler, Rainer, Marcon, Francesca, Nielsen, Elsa, Vleminckx, Christiane, Carfì, Maria, Martino, Carla, Maurici, Daniela, Parra Morte, Juan, Rossi, Annamaria, Benford, Diane, EFSA Scientific Committee, More, Simon John, Bampidis, Vasileios, Bragard, Claude, Halldorsson, Thorhallur Ingi, Hernández-Jerez, Antonio F, Hougaard Bennekou, Susanne, Koutsoumanis, Kostas, Lambré, Claude, Machera, Kyriaki, Naegeli, Hanspeter, Nielsen, Søren Saxmose, Schlatter, Josef, Schrenk, Dieter, Turck, Dominique, Younes, Maged, Aquilina, Gabriele, Bignami, Margherita, Bolognesi, Claudia, Crebelli, Riccardo, Gürtler, Rainer, Marcon, Francesca, Nielsen, Elsa, Vleminckx, Christiane, Carfì, Maria, Martino, Carla, Maurici, Daniela, Parra Morte, Juan, Rossi, Annamaria, and Benford, Diane
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The EFSA Scientific Committee was asked to provide guidance on the most appropriate in vivo tests to follow up on positive in vitro results for aneugenicity, and on the approach to risk assessment for substances that are aneugenic but not clastogenic nor causing gene mutations. The Scientific Committee confirmed that the preferred approach is to perform an in vivo mammalian erythrocyte micronucleus test with a relevant route of administration. If this is positive, it demonstrates that the substance is aneugenic in vivo. A negative result with evidence that the bone marrow is exposed to the test substance supports a conclusion that aneugenic activity is not expressed in vivo. If there is no evidence of exposure to the bone marrow, a negative result is viewed as inconclusive and further studies are required. The liver micronucleus assay, even though not yet fully validated, can provide supporting information for substances that are aneugenic following metabolic activation. The gastrointestinal micronucleus test, conversely, to be further developed, may help to assess aneugenic potential at the initial site of contact for substances that are aneugenic in vitro without metabolic activation. Based on the evidence in relation to mechanisms of aneugenicity, the Scientific Committee concluded that, in principle, health-based guidance values can be established for substances that are aneugenic but not clastogenic nor causing gene mutations, provided that a comprehensive toxicological database is available. For situations in which the toxicological database is not sufficient to establish health-based guidance values, some approaches to risk assessment are proposed. The Scientific Committee recommends further development of the gastrointestinal micronucleus test, and research to improve the understanding of aneugenicity to support risk assessment.
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- 2021
9. Novel foods in the European Union: Scientific requirements and challenges of the risk assessment process by the European Food Safety Authority
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Ververis, Ermolaos, primary, Ackerl, Reinhard, additional, Azzollini, Domenico, additional, Colombo, Paolo Angelo, additional, de Sesmaisons, Agnès, additional, Dumas, Céline, additional, Fernandez-Dumont, Antonio, additional, Ferreira da Costa, Lucien, additional, Germini, Andrea, additional, Goumperis, Tilemachos, additional, Kouloura, Eirini, additional, Matijevic, Leonard, additional, Precup, Gabriela, additional, Roldan-Torres, Ruth, additional, Rossi, Annamaria, additional, Svejstil, Roman, additional, Turla, Emanuela, additional, and Gelbmann, Wolfgang, additional
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- 2020
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10. Nonclinical safety strategies for stem cell therapies
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Sharpe, Michaela E., Morton, Daniel, and Rossi, Annamaria
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- 2012
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11. Selection of reference genes in different myocardial regions of an in vivo ischemia/reperfusion rat model for normalization of antioxidant gene expression
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Vesentini Nicoletta, Barsanti Cristina, Martino Alessandro, Kusmic Claudia, Ripoli Andrea, Rossi AnnaMaria, and L'Abbate Antonio
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Medicine ,Biology (General) ,QH301-705.5 ,Science (General) ,Q1-390 - Abstract
Abstract Background Changes in cardiac gene expression due to myocardial injury are usually assessed in whole heart tissue. However, as the heart is a heterogeneous system, spatial and temporal heterogeneity is expected in gene expression. Results In an ischemia/reperfusion (I/R) rat model we evaluated gene expression of mitochondrial and cytoplasmatic superoxide dismutase (MnSod, Cu-ZnSod) and thioredoxin reductase (trxr1) upon short (4 h) and long (72 h) reperfusion times in the right ventricle (RV), and in the ischemic/reperfused (IRR) and the remote region (RR) of the left ventricle. Gene expression was assessed by Real-time reverse-transcription quantitative PCR (RT-qPCR). In order to select most stable reference genes suitable for normalization purposes, in each myocardial region we tested nine putative reference genes by geNorm analysis. The genes investigated were: Actin beta (actb), Glyceraldehyde-3-P-dehydrogenase (gapdh), Ribosomal protein L13A (rpl13a), Tyrosine 3-monooxygenase (ywhaz), Beta-glucuronidase (gusb), Hypoxanthine guanine Phosphoribosyltransferase 1 (hprt), TATA binding box protein (tbp), Hydroxymethylbilane synthase (hmbs), Polyadenylate-binding protein 1 (papbn1). According to our findings, most stable reference genes in the RV and RR were hmbs/hprt and hmbs/tbp/hprt respectively. In the IRR, six reference genes were recommended for normalization purposes; however, in view of experimental feasibility limitations, target gene expression could be normalized against the three most stable reference genes (ywhaz/pabp/hmbs) without loss of sensitivity. In all cases MnSod and Cu-ZnSod expression decreased upon long reperfusion, the former in all myocardial regions and the latter in IRR alone. trxr1 expression did not vary. Conclusions This study provides a validation of reference genes in the RV and in the anterior and posterior wall of the LV of cardiac ischemia/reperfusion model and shows that gene expression should be assessed separately in each region.
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- 2012
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12. Safety evaluation of the food enzyme α-amylase from a genetically modified Bacillus licheniformis (strain NZYM-AV)
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EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), Silano, Vittorio, Bolognesi, Claudia, Castle, Laurence, Chipman, Kevin, Cravedi, Jean-Pierre, Fowler, Paul, Franz, Roland, Grob, Konrad, Gürtler, Rainer, Husøy, Trine, Kärenlampi, Sirpa, Mennes, Wim, Milana, Maria Rosaria, Pfaff, Karla, Riviere, Gilles, Srinivasan, Jannavi, Tavares Poças, Maria de Fátima, Tlustos, Christina, Wölfle, Detlef, Zorn, Holger, Chesson, Andrew, Glandorf, Boet, Herman, Lieve, Jany, Klaus‐Dieter, Marcon, Francesca, Penninks, André, Smith, Andrew, van Loveren, Henk, Želježic, Davor, Aguilera, Jaime, Aguilera‐Gómez, Margarita, Kovalkovicová, Natália, Maia, Joaquim, Rossi, Annamaria, Engel, Karl‐Heinz, Veritati - Repositório Institucional da Universidade Católica Portuguesa, European Food Safety Authority (EFSA), ToxAlim (ToxAlim), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Ecole Nationale Vétérinaire de Toulouse (ENVT), Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Ecole d'Ingénieurs de Purpan (INPT - EI Purpan), and Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Recherche Agronomique (INRA)
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1,4‐α‐d‐glucan glucanohydrolase ,4-α-d-glucan glucanohydrolase ,Veterinary (miscellaneous) ,Ingénierie des aliments ,Plant Science ,EC 3.2.1.1 ,4‐α‐d‐glucan glucanohydrolase ,Microbiology ,1,4-α-d-glucan glucanohydrolase ,03 medical and health sciences ,0302 clinical medicine ,α‐amylase ,[SDV.IDA]Life Sciences [q-bio]/Food engineering ,Bacillus licheniformis ,Food and Nutrition ,Food engineering ,Food enzyme ,030304 developmental biology ,2. Zero hunger ,Food Ingredients and Packaging ,0303 health sciences ,Genetically modified microorganism ,alpha-amylase ,1,4-alpha-D-glucan glucanohydrolase ,α-amylase ,Scientific Opinion ,030228 respiratory system ,food enzyme ,genetically modified microorganism ,Alimentation et Nutrition ,Animal Science and Zoology ,Parasitology ,[SDV.AEN]Life Sciences [q-bio]/Food and Nutrition ,Food Science - Abstract
International audience; The food enzyme is an alpha-amylase (4-alpha-D-glucan glucanohydrolase; EC 3.2.1.1) produced with the genetically modified Bacillus licheniformis strain NZYM-AV by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production microorganism or its DNA; therefore, there is no safety concern for the environment. The alpha-amylase is intended to be used in starch processing for the production of glucose syrups and distilled alcohol production. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups (by > 99%). Consequently, dietary exposure was not calculated. Genotoxicity tests did not raise a safety concern. The subchronic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. The Panel derived a no observed adverse effect level (NOAEL) at the highest dose level of 796 mg TOS/kg body weight (bw) per day. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens and one match was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the microbial source, the genetic modifications, the manufacturing process, the compositional and biochemical data, the removal of TOS during the intended food production processes and the toxicological and genotoxicity studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
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- 2018
13. Safety evaluation of the food enzyme glucose oxidase from a genetically modified Aspergillus oryzae (strain NZYM-KP)
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EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), Silano, Vittorio, Bolognesi, Claudia, Castle, Laurence, Chipman, Kevin, Cravedi, Jean-Pierre, Fowler, Paul, Franz, Roland, Grob, Konrad, Gürtler, Rainer, Husøy, Trine, Kärenlampi, Sirpa, Mennes, Wim, Milana, Maria Rosaria, Pfaff, Karla, Riviere, Gilles, Srinivasan, Jannavi, Tavares Poças, Maria de Fátima, Tlustos, Christina, Wölfle, Detlef, Zorn, Holger, Chesson, Andrew, Glandorf, Boet, Herman, Lieve, Jany, Klaus‐Dieter, Marcon, Francesca, Penninks, André, Smith, Andrew, van Loveren, Henk, Želježic, Davor, Andryszkiewicz, Magdalena, Liu, Yi, Rossi, Annamaria, Engel, Karl‐Heinz, Veritati - Repositório Institucional da Universidade Católica Portuguesa, ToxAlim (ToxAlim), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Ecole Nationale Vétérinaire de Toulouse (ENVT), Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Ecole d'Ingénieurs de Purpan (INPT - EI Purpan), and Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Recherche Agronomique (INRA)
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Allergy ,enzyme alimentaire ,Aspergillus oryzae ,Ingénierie des aliments ,Plant Science ,Gene mutation ,medicine.disease_cause ,Allergen ,[SDV.IDA]Life Sciences [q-bio]/Food engineering ,Food science ,food enzyme ,glucose oxidase ,beta-D-glucose:oxygen 1-oxidoreductase ,genetically modified microorganism ,2. Zero hunger ,chemistry.chemical_classification ,Genetically modified microorganism ,biology ,Gmo ,04 agricultural and veterinary sciences ,040401 food science ,Genetically modified organism ,sécurité alimentaire ,Toxicity ,Alimentation et Nutrition ,Veterinary (miscellaneous) ,Microbiology ,Beta-d-glucose:oxygen 1-oxidoreductase ,0404 agricultural biotechnology ,oxydase ,medicine ,Food engineering ,Food and Nutrition ,Food enzyme ,oxygen 1-oxidoreductase [Beta-d-glucose] ,business.industry ,aspergillus niger ,EC 1.1.3.4 ,Food safety ,biology.organism_classification ,medicine.disease ,Enzyme ,Scientific Opinion ,chemistry ,beta‐d‐glucose:oxygen 1‐oxidoreductase ,Animal Science and Zoology ,Parasitology ,Glucose oxidase ,business ,[SDV.AEN]Life Sciences [q-bio]/Food and Nutrition ,Food Science ,glucose oxydase - Abstract
International audience; The food enzyme is a glucose oxidase (beta-D-glucose:oxygen 1-oxidoreductase; EC 1.1.3.4) produced with a genetically modified strain of Aspergillus oryzae strain NZYM-KP by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production organism or DNA; therefore, there is no safety concern for the environment. The glucose oxidase is intended to be used in baking processes. Based on the maximum use levels recommended and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.156 mg TOS/kg body weight (bw) per day in European populations. The food enzyme did not induce gene mutations in bacteria or chromosome aberrations in human lymphocytes. The subchronic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no-observed-adverse-effect level was derived (341 mg TOS/kg bw per day), which compared with the estimated dietary exposure results in a sufficiently high margin of exposure. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens and one match with a fungal contact allergen was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the microbial source, the genetic modifications, the manufacturing process, the compositional and biochemical data, the estimated dietary exposure and the findings in the toxicological studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
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- 2018
14. Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Bacillus licheniformis (strain NZYM‐AN)
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EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), Silano, Vittorio, Bolognesi, Claudia, Castle, Laurence, Chipman, Kevin, Cravedi, Jean-Pierre, Fowler, Paul, Franz, Roland, Grob, Konrad, Gürtler, Rainer, Husøy, Trine, Kärenlampi, Sirpa, Mennes, Wim, Milana, Maria Rosaria, Pfaff, Karla, Riviere, Gilles, Srinivasan, Jannavi, Tavares Poças, Maria de Fátima, Tlustos, Christina, Wölfle, Detlef, Zorn, Holger, Chesson, Andrew, Glandorf, Boet, Herman, Lieve, Jany, Klaus‐Dieter, Marcon, Francesca, Penninks, André, Smith, Andrew, van Loveren, Henk, Želježic, Davor, Aguilera, Jaime, Andryszkiewicz, Magdalena, Kovalkovicová, Natália, Rossi, Annamaria, Engel, Karl‐Heinz, Veritati - Repositório Institucional da Universidade Católica Portuguesa, ToxAlim (ToxAlim), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Ecole Nationale Vétérinaire de Toulouse (ENVT), Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Ecole d'Ingénieurs de Purpan (INPT - EI Purpan), and Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Recherche Agronomique (INRA)
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4-α-d-glucan glucanohydrolase ,Veterinary (miscellaneous) ,Ingénierie des aliments ,Plant Science ,EC 3.2.1.1 ,Microbiology ,1,4-α-d-glucan glucanohydrolase ,03 medical and health sciences ,0302 clinical medicine ,[SDV.IDA]Life Sciences [q-bio]/Food engineering ,Bacillus licheniformis ,Food enzyme ,Food and Nutrition ,Food engineering ,030304 developmental biology ,2. Zero hunger ,0303 health sciences ,Genetically modified microorganism ,Alpha-amylase ,030228 respiratory system ,Alimentation et Nutrition ,4-alpha-D-glucan glucanohydrolase ,food enzyme ,alpha-amylase ,1,4-alpha-D-glucan glucanohydrolase ,genetically modified microorganism ,Animal Science and Zoology ,Parasitology ,[SDV.AEN]Life Sciences [q-bio]/Food and Nutrition ,Food Science - Abstract
International audience; The food enzyme is an alpha-amylase (4-alpha-D-glucan glucanohydrolase; EC 3.2.1.1) produced with a genetically modified Bacillus licheniformis strain NZYM-AN by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production organism or recombinant DNA; therefore, there is no safety concern for the environment. The alpha-amylase is intended to be used in starch processing for the production of glucose syrups and distilled alcohol production. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups (by > 99%). Consequently, dietary exposure was not calculated. Genotoxicity tests with the food enzyme did not raise a safety concern. The amino acid sequence of the food enzyme did not match to those of known allergens. The Panel considered that under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered low. Based on the microbial source, the genetic modifications, the manufacturing process, the compositional and biochemical data, the removal of TOS during the intended food production processes and the findings in the genotoxicity studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
- Published
- 2018
15. Il profilo del laureato magistrale in scienze infermieristiche e ostetriche in Italia: dall’analisi dei regolamenti didattici d’ateneo alle competenze distintive
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Rega, Maria Luisa, Gallo, Rosalba, Marmo, Giuseppe, De Rossi, Annamaria, De Vito, Corrado, Damiani, Gianfranco, and Galletti, Caterina
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corso di laure magistrale ,sviluppo professionale ,sviluppo competenze ,pratica infermieristica avanzata ,Settore MED/45 - SCIENZE INFERMIERISTICHE GENERALI, CLINICHE E PEDIATRICHE - Published
- 2015
16. EFSA Scientific Colloquium 22 – Epigenetics and risk assessment: where do we stand?
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Bahadori, Tina, Bell, David, Ceccatelli, Sandra, Corvi, Raffaella, Hogstrand, Christer, Munn, Sharon, Nilsson, Eric, Spurgeon, David, Vom Brocke, Jochen, Wright, Matt, Binaglia, Marco, Dorne, Jean‐Lou, Georgiadis, Nikolaos, Germini, Andrea, Kass, George, Robinson, Tobin, Rossi, Annamaria, Schoonjans, Reinhilde, Terron, Andrea, Noteborn, Hubert, Bahadori, Tina, Bell, David, Ceccatelli, Sandra, Corvi, Raffaella, Hogstrand, Christer, Munn, Sharon, Nilsson, Eric, Spurgeon, David, Vom Brocke, Jochen, Wright, Matt, Binaglia, Marco, Dorne, Jean‐Lou, Georgiadis, Nikolaos, Germini, Andrea, Kass, George, Robinson, Tobin, Rossi, Annamaria, Schoonjans, Reinhilde, Terron, Andrea, and Noteborn, Hubert
- Abstract
Event report. The issue of epigenetic changes and their impact on human health and life span was prominently discussed at EFSA’s second scientific conference ‘Shaping the future of food safety, together’ in Milan. Epigenetic changes are molecular changes mainly in chromatin, such as DNA methylation, histone modifications, that modulate gene expression directly or indirectly through the expression of noncoding RNAs. There is increasing evidence to suggest that individual lifestyles, nutrition and environmental stressors can affect epigenetic processes and as a result, alter phenotypes, longevity, health and disease both within generations (from embryogenesis to adulthood) and in a transgenerational manner. In response to the interest in this issue, EFSA has selected epigenetics as the subject of its 22nd scientific colloquium, which was held on 14 and 15 June 2016 in Valencia, Spain. About 100 scientists, risk managers and policymakers discussed where we stand regarding our knowledge of epigenetic mechanisms. The overall objective of the discussions was to identify the potential role of epigenetics in food safety risk assessment. The colloquium was organised around four discussion groups looking at the following themes: incorporating epigenetics data in mode of action analysis; epigenetics and chemical risk assessment in humans; epigenetics in risk assessment of farmed animals for food production; epigenetics and environmental risk assessment. The main takehome message from the colloquium was to ask and seek answers to those questions that will increase our understanding of epigenetics. What do epigenetic modifications mean for safety assessment? How do we study them? What is the size of such modifications that we need worry about? Cooperation and collaboration between the various scientific disciplines and with the clinical side of epidemiology was identified as a necessary strategic element to improve scientific risk assessment.
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- 2016
17. Missione a Malta
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Rossignani, Maria Pia, Perassi, Claudia, Locatelli, Davide, Rossi, Annamaria, and Bergamaschi, Chiara
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scavi archeologici ,conservazione ,Malta ,San Pawl Milqi ,Settore L-ANT/07 - ARCHEOLOGIA CLASSICA ,Tas-Silg - Published
- 2005
18. Assessing the Safety of Stem Cell Therapeutics
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Goldring, Chris E.P., primary, Duffy, Paul A., additional, Benvenisty, Nissim, additional, Andrews, Peter W., additional, Ben-David, Uri, additional, Eakins, Rowena, additional, French, Neil, additional, Hanley, Neil A., additional, Kelly, Lorna, additional, Kitteringham, Neil R., additional, Kurth, Jens, additional, Ladenheim, Deborah, additional, Laverty, Hugh, additional, McBlane, James, additional, Narayanan, Gopalan, additional, Patel, Sara, additional, Reinhardt, Jens, additional, Rossi, Annamaria, additional, Sharpe, Michaela, additional, and Park, B. Kevin, additional
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- 2011
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19. Molecular mechanisms of metal toxicity in neuronal cells
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Rossi, Annamaria and Rossi, Annamaria
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Modification of signal transduction by toxic agents can affect cell metabolism and physiological activity, impair cell capacity to adequately respond to hormones and growth stimuli and consequently compromise cell survival. This thesis describes studies on the interactions between toxic metals, at concentrations comparable to environmental exposure, and Ca2+ signalling in neuronal cells. Four tri-substituted organotin compounds (triethyltin (TET), trimethyltin (TMT), tributyltin (TBT), triphenyltin (TPT)), as well as organic (methylmercury, MeHg) and inorganic (Hg2+) forms of mercury were studied. The role of the altered Ca2+ signalling in neurotoxicity of organotin compounds was investigated in PC12 cells. Micromolar concentrations of TBT and TPT caused intracellular Ca2+ overload, due to both enhanced Ca2+ influx and release from intracellular stores. Conditions that caused a transient increase were non-cytotoxic, whereas a Ca2+ elevation sustained for at least 30 min. induced apoptosis. In our system, TMT did not induce any measurable effect. TET induced a modest increase in intracellular Ca2+ and interfered with the Ca2+ signals induced by ATP, bradykinin (Bk) and K+. Although TET alone did not elicit norepinephrine (NE) release, it enhanced the release of NE induced by Bk and ATP. These results suggest that neurotoxic effects of TET are related to its ability to modulate Ca2+ signalling and eventually neurosecretion. Mercury has been shown to be highly toxic to the CNS, particularly during development. We have found that nanomolar concentrations of Hg2+ enhanced NGF-induced differentiation in PC12 cells. This effect was apparently related to a modification of the activated state of the L-type Ca2+ channel, which resulted in an increased Ca2+ influx during depolarization and agonist stimulation. Conversely, marginally higher Hg2+ concentrations (1-2 ~lM) inhibited depolarization and agonist-induced Ca2+ response and caused cell death. The cytotoxic effects of Hg
- Published
- 1996
20. The Na+Ca2+ exchanger activity in cerebrocortical nerve endings is reduced in old compared to young and mature rats when it operates as a Ca2+ influx or efflux pathway
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Canzoniero, Lorella M.T., primary, Rossi, Annamaria, additional, Taglialatela, Maurizio, additional, Amoroso, Salvatore, additional, Annunziato, Lucio, additional, and Di Renzo, Gianfranco, additional
- Published
- 1992
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21. A Roadmap for the Development of Alternative (Non-Animal) Methods for Systemic Toxicity Testing.
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Basketter, David A., Clewell, Harvey, Kimber, Ian, Rossi, Annamaria, Blaauboer, Bas, Burrier, Robert, Daneshian, Mardas, Eskes, Chantra, Goldberg, Alan, Hasiwa, Nina, Hoffmann, Sebastian, Jaworska, Joanna, Knudsen, Thomas B., Landsiedel, Robert, Leist, Marcel, Locke, Paul, Maxwell, Gavin, McKim, James, McVey, Emily A., and Ouédraogo, Gladys
- Abstract
Systemic toxicity testing forms the cornerstone for the safety evaluation of substances. Pressures to move from traditional animal models to novel technologies arise from various concerns, including: the need to evaluate large numbers of previously untested chemicals and new products (such as nanoparticles or cell therapies), the limited predictivity of traditional tests for human health effects, duration and costs of current approaches, and animal welfare considerations. The latter holds especially true in the context of the scheduled 2013 marketing ban on cosmetic ingredients tested for systemic toxicity. Based on a major analysis of the status of alternative methods (Adler et al., 2011) and its independent review (Hartung et al., 2011), the present report proposes a roadmap for how to overcome the acknowledged scientific gaps for the full replacement of systemic toxicity testing using animals. Five whitepapers were commissioned addressing toxicokinetics, skin sensitization, repeated-dose toxicity, carcinogenicity, and reproductive toxicity testing. An expert workshop of 35 participants from Europe and the US discussed and refined these whitepapers, which were subsequently compiled to form the present report. By prioritizing the many options to move the field forward, the expert group hopes to advance regulatory science. [ABSTRACT FROM AUTHOR]
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- 2012
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22. Trace metal lung disease: In vitro interaction of hard metals with human lung and plasma components
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Edel, Johanna, primary, Sabbioni, Enrico, additional, Pietra, Romano, additional, Rossi, Annamaria, additional, Torre, Massimo, additional, Rizzato, Gianfranco, additional, and Fraioli, Patrizia, additional
- Published
- 1990
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23. Outcome of the public consultation on the draft statement on genotoxicity assessment of chemical mixtures.
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Carfì, Maria, Manini, Paola, Martino, Carla, Maurici, Daniela, Morte, Juan Parra, Rossi, Annamaria, Vettori, Maria Vittoria, and Schlatter, Josef
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SCIENTIFIC community - Abstract
The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the genotoxicity assessment of chemical mixtures. The draft statement was prepared by a dedicated working group of the Scientific Committee and endorsed by the Scientific Committee for public consultation at its 89th plenary meeting of 28‐29 May 2018. The public consultation for this document was open from 26 June until 9 September 2018. EFSA received 73 comments from 16 interested parties. EFSA's Scientific Committee wishes to thank all stakeholders for their contributions. This report presents statistics on the comments received and provides a summarised description of how the comments were addressed in the finalisation of the document. The stakeholders valuable and detailed comments were taken into account by the Scientific Committee to prepare an updated version of the statement on genotoxicity assessment of mixtures. The statement was discussed and adopted at the Scientific Committee plenary meeting on 22 November 2018, and is published in the EFSA Journal. This publication is linked to the following EFSA Journal article: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2019.5519/full [ABSTRACT FROM AUTHOR]
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- 2019
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24. A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing
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Ruhdel, Irmela, Vanparys, Philippe, Knudsen, Thomas B., Roggen, Erwin, Oué, draogo, Gladys, Basketter, David A., Daneshian, Mardas, Eskes, Chantra, Rossi, Annamaria, Skinner, Nigel, Blaauboer, Bas, Pelkonen, Olavi, Maxwell, Gavin, Yager, James, Kimber, Ian, Rovida, Constanza, Patlewicz, Grace, Hoffmann, Sebastian, Jaworska, Joana, Mckim, James, Trentz, Kerstin, Turner, Marian, Landsiedel, Robert, Goldberg, Alan, Hasiwa, Nina, Zurlo, Joanne, Schoeters, Greet, Hartung, Thomas, Leist, Marcel, Clewell, Harvey, Locke, Paul, Mcvey, Emily A., Burrier, Robert, Schepky, Andreas, and Schwarz, Michael
25. Nurses with Master of Science in nursing and midwifery in Italy: from the analysis of the academic regulations to the core competences.
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Rega, Maria Luisa, Gallo, Rosalba, Marmo, Giuseppe, De Rossi, Annamaria, De Vito, Corrado, Damiani, Gianfranco, and Galletti, Caterina
- Published
- 2015
26. Search strategies for the maintenance and update of list of QPS-recommended biological agents
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EFSA BIOHAZ Panel, Koutsoumanis, Kostas, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Cocconcelli, Pier Sandro, Fernández Escámez, Pablo Salvador, Maradona, Miguel Prieto, Querol, Amparo, Sijtsma, Lolke, Suarez, Juan Evaristo, Sundh, Ingvar, Vlak, Just, Barrizzone, Fulvio, Correia, Sandra, Herman, Lieve, Munoz Guajardo, Irene, Da Costa, Irene, Aguillera‐Gomez, Margarita, Aguillera, Jaime, Gelbmann, Wolfgang, Brozzi, Rosella, Bote, Katrin, Heng, Leng, Istace, Frédérique, Richardson, Malcolm, Romero, Patricia, and Rossi, Annamaria
- Subjects
search strategy ,qualification ,QPS - Abstract
The aim of the Extensive Literature Search (ELS) carried out in response to the terms of reference set out in the EFSA mandate on the Qualified Presumption of safety (QPS), i.e. review of the recommendations for the QPS list and specific qualifications, was to identify any publicly available studies reporting on safety concerns for humans, animals or the environment caused by organisms that have QPS status, since the publication of the previous QPS review in 2016 (i.e. publications from June 2016 to June 2019). The details on the search strategy, search keys and approach are presented here. Notes to the versions: - 27 January 2022 and 25 July 2022: The search strategy has been updated to reflect additions to the QPS list and changes in taxonomy. - 25 January 2023 version is linked to QPS part 17, ON-7746. -10 July 2023 version is linked to QPS part 18, ON-8092, EU; PDF; biohaz@efsa.europa.eu
- Published
- 2023
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- View/download PDF
27. Protocol for Extensive literature search (ELS) for the maintenance and update of list of QPS-recommended biological agents
- Author
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EFSA BIOHAZ Panel, Koutsoumanis, Kostas, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Cocconcelli, Pier Sandro, Fernández Escámez, Pablo Salvador, Maradona, Miguel Prieto, Querol, Amparo, Sijtsma, Lolke, Suarez, Juan Evaristo, Sundh, Ingvar, Vlak, Just, Barrizzone, Fulvio, Correia, Sandra, Herman, Lieve, Aguillera‐Gomez, Margarita, Aguillera, Jaime, Gelbmann, Wolfgang, Brozzi, Rosella, Bote, Katrin, Heng, Leng, Istace, Frédérique, Richardson, Malcolm, Romero, Patricia, Rossi, Annamaria, Munoz Guajardo, Irene, and Da Costa, Irene
- Subjects
extensive literature search ,protocol ,QPS - Abstract
Protocol for Extensive literature search (ELS), relevance screening and article evaluation for the maintenance and update of list of QPS-recommended biological agents intentionally added to food an feed An ELS of studies related to safety concerns for humans, animals, plants and/or the environment of microorganisms recommended for the Qualified Presumption of Safety (QPS) 2019 list will be performed. The process will be performed according to the following main steps: ELS for potentially relevant citations; Relevance screening to select the citations identified by the literature search, based on titles and abstract and then full text; Evaluation of articles according to pre-specified categories of possible safety concerns; Discussion between experts to come to collective expert evaluation of the outcome, reflected in the QPS Opinion and Panel Statements. Considering the purpose of the QPS approach, a broad search will be performed. The review questions will be broken down into key elements using the PECO conceptual model: Population of interest (P) Exposure of interest (E) Comparator (C) Outcomes of interest (O). Notes: - to 27 January 2022 version: The protocol has been updated to reflect additions to the QPS list and changes in taxonomy. - to 25 Jan. 2023 version: protocol related to QPS Part 17, ON-7746. - to 10 July 2023 version: protocol related to QPS Part 18, ON-8092., EU; PDF; biohaz@efsa.europa.eu
- Published
- 2022
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28. Nonclinical safety strategies for stem cell therapies
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Rossi, Annamaria [Investigative Toxicology, Drug Safety Research and Development, Pfizer Ltd, Ramsgate Road, Sandwich, CT13 9NJ (United Kingdom)]
- Published
- 2012
- Full Text
- View/download PDF
29. Search strategies for the maintenance and update of list of QPS-recommended biological agents
- Author
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EFSA BIOHAZ Panel, Koutsoumanis, Kostas, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Hilbert, Fiederike, Lindqvist, Roland, Nauta, Maarten, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Cocconcelli, Pier Sandro, Fernández Escámez, Pablo Salvador, Maradona, Miguel Prieto, Querol, Amparo, Suarez, Juan Evaristo, Sundh, Ingvar, Vlak, Just, Barrizzone, Fulvio, Correia, Sandra, Herman, Lieve, Aguillera‐Gomez, Margarita, Aguillera, Jaime, Gelbmann, Wolfgang, Brozzi, Rosella, Bote, Katrin, Heng, Leng, Istace, Frédérique, Richardson, Malcolm, Romero, Patricia, and Rossi, Annamaria
- Abstract
The aim of the Extensive Literature Search (ELS) carried out in response to the terms of reference set out in the EFSA mandate on the Qualified Presumption of safety (QPS), i.e.review of the recommendations for the QPS list and specific qualifications,was to identify any publicly available studies reporting on safety concerns for humans, animals or the environment caused by organisms that have QPS status, since the publication of the previous QPS review in 2016 (i.e. publications from June 2016 to June 2019). The details on the search strategy, search keys andapproach are presented here.
- Published
- 2020
- Full Text
- View/download PDF
30. Extensive Literature Search Protocol - 2019 QPS update
- Author
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EFSA BIOHAZ Panel, Koutsoumanis, Kostas, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Hilbert, Fiederike, Lindqvist, Roland, Nauta, Maarten, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Cocconcelli, Pier Sandro, Fernández Escámez, Pablo Salvador, Maradona, Miguel Prieto, Querol, Amparo, Suarez, Juan Evaristo, Sundh, Ingvar, Vlak, Just, Barrizzone, Fulvio, Correia, Sandra, Herman, Lieve, Aguillera‐Gomez, Margarita, Aguillera, Jaime, Gelbmann, Wolfgang, Brozzi, Rosella, Bote, Katrin, Heng, Leng, Istace, Frédérique, Richardson, Malcolm, Romero, Patricia, and Rossi, Annamaria
- Subjects
extensive literature search ,protocol ,QPS - Abstract
Protocol for Extensive literature search (ELS), relevance screening and article evaluation for the maintenance and update of list of QPS-recommended biological agents intentionally added to food an feed An ELS of studies related to safety concerns for humans, animals, plants and/or the environment of microorganisms recommended for the Qualified Presumption of Safety (QPS) 2019 list will be performed. The process will be performed according to the following main steps: ELS for potentially relevant citations; Relevance screening to select the citations identified by the literature search, based on titles and abstract and then full text; Evaluation of articles according to pre-specified categories of possible safety concerns; Discussion between experts to come to collective expert evaluation of the outcome, reflected in the QPS Opinion and Panel Statements. Considering the purpose of the QPS approach, a broad search will be performed. The review questions will be broken down into key elements using the PECO conceptual model: Population of interest (P) Exposure of interest (E) Comparator (C) Outcomes of interest (O).
- Published
- 2020
- Full Text
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31. Guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283.
- Author
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Turck D, Bohn T, Castenmiller J, de Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Aguilera Gómez M, Cubadda F, Frenzel T, Heinonen M, Neuhäuser-Berthold M, Peláez C, Poulsen M, Prieto Maradona M, Schlatter JR, Siskos A, van Loveren H, Ackerl R, Albert O, Azzollini D, Fernández Dumont A, Gelbmann W, Germini A, Glymenaki M, Kass GEN, Kouloura E, Laganaro M, Matijevic L, Mendes V, Noriega Fernández E, Nuin Garciarena I, Precup G, Roldán Torres R, Rossi A, Turla E, Valtueña Martinez S, Ververis E, and Knutsen HK
- Abstract
The European Commission requested EFSA to update the scientific guidance for the preparation of applications for authorisation of novel foods, previously developed following the adoption of Regulation (EU) 2015/2283 on novel foods. This guidance document provides advice on the scientific information needed to be submitted by the applicant towards demonstrating the safety of the novel food. Requirements pertain to the description of the novel food, production process, compositional data, specifications, proposed uses and use levels and anticipated intake of the novel food. Furthermore, information needed in sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, toxicological information, nutritional information and allergenicity is also described. The applicant should integrate and interpret the data presented in the different sections to provide their overall considerations on how the information supports the safety of the novel food under the proposed conditions of use. Where potential health hazards have been identified, they are to be discussed in relation to the anticipated intake of the novel food and the proposed target populations. On the basis of the information provided, EFSA will assess the safety of the novel food under the proposed conditions of use., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2024
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32. Safety of HelixComplex snail mucus (HSM) as a novel food pursuant to Regulation (EU) 2015/2283.
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Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Aguilera-Gómez M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhäuser-Berthold M, Peláez C, Poulsen M, Maradona MP, Schlatter JR, Siskos A, van Loveren H, Magani M, Muñoz A, Rossi A, and Knutsen HK
- Abstract
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on HelixComplex Snail Mucus (HSM) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of snail mucus collected from Helix aspersa maxima and is proposed to be used by adults as a food supplement. The data provided by the applicant about the composition and stability of the NF together with the report of the subchronic toxicity study were overall considered unsatisfactory. The Panel noted inconsistencies in the reporting of the certificates of analysis and of the data on the subchronic toxicity provided by the applicant. Owing to these deficiencies, the Panel cannot establish a safe intake level of the NF. The Panel concludes that the safety of the NF has not been established., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2024
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33. Safety of an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Aguilera-Gómez M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhäuser-Berthold M, Poulsen M, Prieto Maradona M, Siskos A, Schlatter JR, van Loveren H, Muñoz González A, Rossi A, Ververis E, and Knutsen HK
- Abstract
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is an ethanolic extract of the dried biomass of the microalga P. tricornutum diluted in a medium-chain triglyceride oil carrier, with standardised fucoxanthin and tocopherol content. The main component of the NF is fat (78% on average), followed by crude protein (10% on average). The Panel is of the view that a consistent and safe production process has not been demonstrated. Additionally, the Panel considers that the information provided on the composition of the NF is not complete and may raise safety concerns. The applicant proposed to use the NF as a food supplement at the use level of 437 mg/day, with the target population being adults, excluding pregnant and breastfeeding women. There is no history of use of the NF or of its source, i.e. P. tricornutum . The Panel notes that the source of the NF, P. tricornutum , was not granted the qualified presumption of safety (QPS) status by the EFSA Panel on Biological Hazards (BIOHAZ), due to the lack of a safe history of use in the food chain and on its potential for production of bioactive compounds with toxic effects. There were no concerns regarding genotoxicity of the NF. In the 90-day study provided, a number of adverse effects were observed, some of them seen already at the lowest dose tested (750 mg/kg body weight (bw) day), which was identified by the Panel as the lowest-observed-adverse-effect-level (LOAEL). The potential phototoxicity of pheophorbide A and pyropheophorbide A in the NF was not addressed in this study. Although noting the uncertainties identified by the Panel regarding the analytical determination of these substances in the NF and the limitations in the publicly available toxicity data, a low margin of exposure (MoE) was calculated for these substances at the proposed use levels. The Panel concludes that the safety of the NF under the proposed uses and use levels has not been established., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2023
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34. Statement on safety of cannabidiol as a novel food: data gaps and uncertainties.
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Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhäuser-Berthold M, Poulsen M, Prieto Maradona M, Schlatter JR, Trezza V, van Loveren H, Albert O, Dumas C, Germini A, Gelbmann W, Kass G, Kouloura E, Noriega Fernandez E, Rossi A, and Knutsen HK
- Abstract
The European Commission has determined that cannabidiol (CBD) can be considered as a novel food (NF), and currently, 19 applications are under assessment at EFSA. While assessing these, it has become clear that there are knowledge gaps that need to be addressed before a conclusion on the safety of CBD can be reached. Consequently, EFSA has issued this statement, summarising the state of knowledge on the safety of CBD consumption and highlighting areas where more data are needed. Literature searches for both animal and human studies have been conducted to identify safety concerns. Many human studies have been carried out with Epidyolex
® , a CBD drug authorised to treat refractory epilepsies. In the context of medical conditions, adverse effects are tolerated if the benefit outweighs the adverse effect. This is, however, not acceptable when considering CBD as a NF. Furthermore, most of the human data referred to in the CBD applications investigated the efficacy of Epidyolex (or CBD) at therapeutic doses. No NOAEL could be identified from these studies. Given the complexity and importance of CBD receptors and pathways, interactions need to be taken into account when considering CBD as a NF. The effects on drug metabolism need to be clarified. Toxicokinetics in different matrices, the half-life and accumulation need to be examined. The effect of CBD on liver, gastrointestinal tract, endocrine system, nervous system and on psychological function needs to be clarified. Studies in animals show significant reproductive toxicity, and the extent to which this occurs in humans generally and in women of child-bearing age specifically needs to be assessed. Considering the significant uncertainties and data gaps, the Panel concludes that the safety of CBD as a NF cannot currently be established., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)- Published
- 2022
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35. Guidance on aneugenicity assessment.
- Author
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More SJ, Bampidis V, Bragard C, Halldorsson TI, Hernández-Jerez AF, Hougaard Bennekou S, Koutsoumanis K, Lambré C, Machera K, Naegeli H, Nielsen SS, Schlatter J, Schrenk D, Turck D, Younes M, Aquilina G, Bignami M, Bolognesi C, Crebelli R, Gürtler R, Marcon F, Nielsen E, Vleminckx C, Carfì M, Martino C, Maurici D, Parra Morte J, Rossi A, and Benford D
- Abstract
The EFSA Scientific Committee was asked to provide guidance on the most appropriate in vivo tests to follow up on positive in vitro results for aneugenicity, and on the approach to risk assessment for substances that are aneugenic but not clastogenic nor causing gene mutations. The Scientific Committee confirmed that the preferred approach is to perform an in vivo mammalian erythrocyte micronucleus test with a relevant route of administration. If this is positive, it demonstrates that the substance is aneugenic in vivo . A negative result with evidence that the bone marrow is exposed to the test substance supports a conclusion that aneugenic activity is not expressed in vivo . If there is no evidence of exposure to the bone marrow, a negative result is viewed as inconclusive and further studies are required. The liver micronucleus assay, even though not yet fully validated, can provide supporting information for substances that are aneugenic following metabolic activation. The gastrointestinal micronucleus test, conversely, to be further developed, may help to assess aneugenic potential at the initial site of contact for substances that are aneugenic in vitro without metabolic activation. Based on the evidence in relation to mechanisms of aneugenicity, the Scientific Committee concluded that, in principle, health-based guidance values can be established for substances that are aneugenic but not clastogenic nor causing gene mutations, provided that a comprehensive toxicological database is available. For situations in which the toxicological database is not sufficient to establish health-based guidance values, some approaches to risk assessment are proposed. The Scientific Committee recommends further development of the gastrointestinal micronucleus test, and research to improve the understanding of aneugenicity to support risk assessment., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
- Published
- 2021
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36. Safety of calcium fructoborate as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck D, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Kearney J, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Peláez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhauser-Berthold M, Poulsen M, Maradona MP, Schlatter JR, van Loveren H, Rossi A, and Knutsen HK
- Abstract
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on calcium fructoborate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, produced by chemical synthesis, contains a maximum of 2.9% of boron and on average 4.7% calcium and 84.2% fructose. It is intended to be marketed as food supplements targeting the general adult population, excluding pregnant and lactating women, at a maximum level of 220 mg/day (maximum boron intake of 6.4 mg per day). The combined intake of boron from the background diet and the NF is in the range of 9.6-9.9 mg/day (corresponding to up to 0.14 mg/kg body weight (bw) per day given a default bw of 70 kg). This is in the range of the acceptable daily intake (ADI) of 0.16 mg/kg bw per day. Under conditions mimicking the gastrointestinal (GI) environment, the NF is fully hydrolysed and the Panel considered boron toxicity relevant for the safety assessment. The Panel considers that there is no concern with respect to genotoxicity of the NF. The effect induced by the NF in a 13-week rat study is consistent with toxicological findings induced by treatment with boron compounds in animal studies. Epididymides-to-brain weight ratio was identified as the most relevant endpoint and the reference point derived was the lowest model averaged BMDL
10 value of 529 mg/kg bw per day. This corresponds to 14.8 mg/kg bw per day of boron, which is higher than the critical no observed adverse effect level (NOAEL) (9.6 mg boron/kg bw per day) used for establishing the ADI of 0.16 mg/kg bw per day for boron. The Panel therefore applied the present ADI for boron in the assessment of the NF. The Panel concludes that the NF, calcium fructoborate, is safe under the proposed uses and use levels., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)- Published
- 2021
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37. Safety evaluation of the food enzyme alpha-amylase from non-genetically modified Aspergillus niger strain (strain DP-Azb60).
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Silano V, Barat Baviera JM, Bolognesi C, Brüschweiler BJ, Cocconcelli PS, Crebelli R, Gott DM, Grob K, Lampi E, Mortensen A, Rivière G, Steffensen IL, Tlustos C, Van Loveren H, Vernis L, Zorn H, Jany KD, Glandorf B, Penninks A, Želježic D, Andryszkiewicz M, Arcella D, Liu Y, Rossi A, Engel KH, and Chesson A
- Abstract
The food enzyme alpha-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with a non-genetically modified Aspergillus niger (strain DP-Azb60) by Danisco US Inc. The food enzyme is free from viable cells of the production organism. The α-amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.503 mg TOS/kg body weight (bw) per day. Genotoxicity tests with the food enzyme did not indicate a genotoxic concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no-observed-adverse-effect level (NOAEL) at the highest dose of 1,000 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (of at least 1,988). Similarity of the amino acid sequence to those of known allergens was searched and one match was found to Asp o 21, an alpha-amylase from Aspergillus oryzae . The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
- Published
- 2019
- Full Text
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38. Safety evaluation of the food enzyme α-amylase from a genetically modified Aspergillus niger (strain NZYM-MC).
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Silano V, Barat Baviera JM, Bolognesi C, Brüschweiler BJ, Cocconcelli PS, Crebelli R, Gott DM, Grob K, Lampi E, Mortensen A, Riviere G, Steffensen IL, Tlustos C, van Loveren H, Vernis L, Zorn H, Kärenlampi S, Marcon F, Penninks A, Smith A, Aguilera-Gómez M, Andryszkiewicz M, Arcella D, Kovalkovičová N, Liu Y, Rossi A, Engel KH, and Chesson A
- Abstract
The food enzyme alpha-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α-amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking processes. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, consequently dietary exposure was not calculated. For baking processes, based on the proposed maximum use levels, dietary exposure to the food enzyme-TOS was estimated to be up to 3.784 mg TOS/kg body weight per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. The Panel identified a no observed adverse effect level (NOAEL) at the highest dose of 1,400 mg TOS/kg body weight (bw) per day. Similarity of the amino acid sequence to those of known allergens was searched and two matches were found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the removal of TOS during the production of glucose syrups and the derived margin of exposure for baking processes, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
- Published
- 2018
- Full Text
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39. Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM-BF).
- Author
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Silano V, Barat Baviera JM, Bolognesi C, Brüschweiler BJ, Cocconcelli PS, Crebelli R, Gott DM, Grob K, Lampi E, Mortensen A, Riviere G, Steffensen IL, Tlustos C, Van Loveren H, Vernis L, Zorn H, Jany KD, Kärenlampi S, Penninks A, Želježic D, Aguilera-Gómez M, Andryszkiewicz M, Arcella D, Gomes A, Kovalkovičová N, Liu Y, Rossi A, Engel KH, and Chesson A
- Abstract
The food enzyme glucoamylase (glucan 1,4-α-glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, consequently dietary exposure was not calculated. For brewing processes, based on the proposed maximum use levels, dietary exposure to the food enzyme-TOS was estimated to be below 3.627 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. The Panel identified a no-observed-adverse-effect level (NOAEL) at the highest dose of 1,360 mg TOS/kg bw per day. Similarity of the amino acid sequence to those of known allergens was searched and one match was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the removal of TOS during the production of glucose syrups and the derived margin of exposure for brewing processes, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
- Published
- 2018
- Full Text
- View/download PDF
40. Safety evaluation of the food enzyme α-amylase from a genetically modified Bacillus licheniformis (strain NZYM-AV).
- Author
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Silano V, Bolognesi C, Castle L, Chipman K, Cravedi JP, Fowler P, Franz R, Grob K, Gürtler R, Husøy T, Kärenlampi S, Mennes W, Milana MR, Pfaff K, Riviere G, Srinivasan J, Tavares Poças MF, Tlustos C, Wölfle D, Zorn H, Chesson A, Glandorf B, Herman L, Jany KD, Marcon F, Penninks A, Smith A, van Loveren H, Želježic D, Aguilera J, Aguilera-Gómez M, Kovalkovicová N, Maia J, Rossi A, and Engel KH
- Abstract
The food enzyme is an α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) produced with the genetically modified Bacillus licheniformis strain NZYM-AV by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production microorganism or its DNA; therefore, there is no safety concern for the environment. The α-amylase is intended to be used in starch processing for the production of glucose syrups and distilled alcohol production. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups (by > 99%). Consequently, dietary exposure was not calculated. Genotoxicity tests did not raise a safety concern. The subchronic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. The Panel derived a no observed adverse effect level (NOAEL) at the highest dose level of 796 mg TOS/kg body weight (bw) per day. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens and one match was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the microbial source, the genetic modifications, the manufacturing process, the compositional and biochemical data, the removal of TOS during the intended food production processes and the toxicological and genotoxicity studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
- Published
- 2018
- Full Text
- View/download PDF
41. Safety evaluation of the food enzyme alpha-amylase from a genetically modified Bacillus licheniformis (strain NZYM-AN).
- Author
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Silano V, Bolognesi C, Castle L, Chipman K, Cravedi JP, Fowler P, Franz R, Grob K, Gürtler R, Husøy T, Kärenlampi S, Mennes W, Milana MR, Pfaff K, Riviere G, Srinivasan J, Tavares Poças MF, Tlustos C, Wölfle D, Zorn H, Chesson A, Glandorf B, Herman L, Jany KD, Marcon F, Penninks A, Smith A, van Loveren H, Želježic D, Aguilera J, Andryszkiewicz M, Kovalkovicová N, Rossi A, and Engel KH
- Abstract
The food enzyme is an α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) produced with a genetically modified Bacillus licheniformis strain NZYM-AN by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production organism or recombinant DNA; therefore, there is no safety concern for the environment. The α-amylase is intended to be used in starch processing for the production of glucose syrups and distilled alcohol production. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups (by > 99%). Consequently, dietary exposure was not calculated. Genotoxicity tests with the food enzyme did not raise a safety concern. The amino acid sequence of the food enzyme did not match to those of known allergens. The Panel considered that under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered low. Based on the microbial source, the genetic modifications, the manufacturing process, the compositional and biochemical data, the removal of TOS during the intended food production processes and the findings in the genotoxicity studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
- Published
- 2018
- Full Text
- View/download PDF
42. Safety evaluation of the food enzyme glucose oxidase from a genetically modified Aspergillus oryzae (strain NZYM-KP).
- Author
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Silano V, Bolognesi C, Castle L, Chipman K, Cravedi JP, Fowler P, Franz R, Grob K, Gürtler R, Husøy T, Kärenlampi S, Mennes W, Milana MR, Pfaff K, Riviere G, Srinivasan J, Tavares Poças MF, Tlustos C, Wölfle D, Zorn H, Chesson A, Glandorf B, Herman L, Jany KD, Marcon F, Penninks A, Smith A, van Loveren H, Želježic D, Andryszkiewicz M, Liu Y, Rossi A, and Engel KH
- Abstract
The food enzyme is a glucose oxidase (beta-d-glucose:oxygen 1-oxidoreductase; EC 1.1.3.4) produced with a genetically modified strain of Aspergillus oryzae strain NZYM-KP by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production organism or DNA; therefore, there is no safety concern for the environment. The glucose oxidase is intended to be used in baking processes. Based on the maximum use levels recommended and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.156 mg TOS/kg body weight (bw) per day in European populations. The food enzyme did not induce gene mutations in bacteria or chromosome aberrations in human lymphocytes. The subchronic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no-observed-adverse-effect level was derived (341 mg TOS/kg bw per day), which compared with the estimated dietary exposure results in a sufficiently high margin of exposure. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens and one match with a fungal contact allergen was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the microbial source, the genetic modifications, the manufacturing process, the compositional and biochemical data, the estimated dietary exposure and the findings in the toxicological studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
- Published
- 2018
- Full Text
- View/download PDF
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