377 results on '"Lostia, Alfonso"'
Search Results
2. Establishing a systematic framework to characterise in vitro methods for human hepatic metabolic clearance
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Gouliarmou, Varvara, Lostia, Alfonso Maria, Coecke, Sandra, Bernasconi, Camilla, Bessems, Jos, Dorne, Jean Lou, Ferguson, Stephen, Testai, Emanuela, Remy, Ursula Gundert, Brian Houston, J., Monshouwer, Mario, Nong, Andy, Pelkonen, Olavi, Morath, Siegfried, Wetmore, Barbara A., Worth, Andrew, Zanelli, Ugo, Zorzoli, Maria Chiara, and Whelan, Maurice
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- 2018
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3. Adverse outcome pathway development from protein alkylation to liver fibrosis
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Horvat, Tomislav, Landesmann, Brigitte, Lostia, Alfonso, Vinken, Mathieu, Munn, Sharon, and Whelan, Maurice
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- 2017
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4. A liquid chromatography/mass spectrometry method for the evaluation of intestinal permeability
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Lostia, Alfonso M., Lionetto, Luana, Principessa, Luigi, Evangelisti, Melania, Gamba, Amelia, Villa, Maria Pia, and Simmaco, Maurizio
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- 2008
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5. HPLC–mass spectrometry method for quantitative detection of neuroendocrine tumor markers: Vanillylmandelic acid, homovanillic acid and 5-hydroxyindoleacetic acid
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Lionetto, Luana, Lostia, Alfonso M., Stigliano, Antonio, Cardelli, Patrizia, and Simmaco, Maurizio
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- 2008
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6. Peer review of the pesticide risk assessment of the active substance Purpureocillium lilacinum strain PL11.
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Castoldi, Anna, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, and Lostia, Alfonso
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RISK assessment ,PESTICIDES ,COMPETENT authority ,ZUCCHINI ,PUMPKINS - Abstract
The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, the United Kingdom, for the pesticide active substance Purpureocillium lilacinum strain PL11 and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of Purpureocillium lilacinum strain PL11 as nematicide on tomato, pepper, aubergine, cucumber, courgette, melon, watermelon, pumpkin (field and greenhouse applications). The reliable endpoints appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. [ABSTRACT FROM AUTHOR]
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- 2022
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7. Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin
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Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chiusolo, Arianna, Court Marques, Daniele, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, Lythgo, Christopher, Magrans, Jose Oriol, Miron, Ileana, Molnar, Tunde, Padovani, Laura, Parra Morte, Juan Manuel, Pedersen, Ragnor, Reich, Hermine, Sacchi, Angela, Santos, Miguel, Serafimova, Rositsa, Sharp, Rachel, Stanek, Alois, Sturma, Juergen, Szentes, Csaba, Terron, Andrea, Theobald, Anne, Vagenende, Benedicte, and Villamar‐Bouza, Laura
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beta‐cyfluthrin ,insecticide ,risk assessment ,pesticide - Abstract
The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Germany, and co‐rapporteur Member State, Hungary, for the pesticide active substance beta‐cyfluthrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of beta‐cyfluthrin as an insecticide on beet, potato, wheat and greenhouse tomato. In addition, this conclusion also addresses the request received from the European Commission during the decision‐making phase following completion of the peer review with regard to the risk to non‐target arthropods. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.
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- 2020
8. Measurement of Ethyl Glucuronide, Ethyl Sulphate and Their Ratio in the Urine and Serum of Healthy Volunteers after Two Doses of Alcohol
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Lostia, Alfonso Maria, Vicente, Joana Lobo, and Cowan, David A.
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- 2013
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9. Finding synergies for 3Rs – Toxicokinetics and read-across: Report from an EPAA partners' Forum
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Laroche, Charles, Aggarwal, Manoj, Bender, Hans, Benndorf, Paul, Birk, Barbara, Crozier, Jonathan, Dal Negro, Gianni, De Gaetano, Federica, Desaintes, Christian, Gardner, Iain, Hubesch, Bruno, Irizar, Amaia, John, David, Kumar, Vikas, Lostia, Alfonso, Manou, Irene, Monshouwer, Mario, Müller, Boris P., Paini, Alicia, Reid, Kirsty, Rowan, Timothy, Sachana, Magdalini, Schutte, Katrin, Stirling, Catrina, Taalman, Rob, van Aerts, Leon, Weissenhorn, Renate, and Sauer, Ursula G.
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- 2018
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10. Chemical safety assessment using read-across: assessing the use of novel testing methods to strengthen the evidence base for decision making
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Berggren, Elisabet, Amcoff, Patric, Benigni, Romualdo, Blackburn, Karen, Carney, Edward, Cronin, Mark, Deluyker, Hubert, Gautier, Francoise, Judson, Richard S., Kass, Georges E.N., Keller, Detlef, Knight, Derek, Lilienblum, Werner, Mahony, Catherine, Rusyn, Ivan, Schultz, Terry, Schwarz, Michael, Schuurmann, Gerrit, White, Andrew, Burton, Julien, Lostia, Alfonso M., Munn, Sharon, and Worth, Andrew
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Chemicals -- Usage -- Safety and security measures ,Cosmetics industry -- Safety and security measures ,Environmental issues ,Health - Abstract
Background: Safety assessment for repeated dose toxicity is one of the largest challenges in the process to replace animal testing. This is also one of the proof of concept ambitions of SEURAT-1, the largest ever European Union research initiative on alternative testing, co-funded by the European Commission and Cosmetics Europe. This review is based on the discussion and outcome of a workshop organized on initiative of the SEURAT-1 consortium joined by a group of international experts with complementary knowledge to further develop traditional read-across and include new approach data. OBJECTIVES: The aim of the suggested strategy for chemical read-across is to show how a traditional read-across based on structural similarities between source and target substance can be strengthened with additional evidence from new approach data--for example, information from in vitro molecular screening, '-omics' assays and computational models--to reach regulatory acceptance. METHODS: We identified four read-across scenarios that cover typical human health assessment situations. For each such decision context, we suggested several chemical groups as examples to prove when read-across between group members is possible, considering both chemical and biological similarities. CONCLUSIONS: We agreed to carry out the complete read-across exercise for at least one chemical category per read-across scenario in the context of SEURAT-1, and the results of this exercise will be completed and presented by the end of the research initiative in December 2015. Environ Health Perspect 123:1232-1240; http://dx.doi.org/10.1289/ehp.1409342, Introduction The research initiative 'Safety Evaluation Ultimately Replacing Animal Testing (SEURAT)' (SEURAT-1 2011) was inspired by the considerations presented in the report of the U.S. National Research Council entitled Toxicity [...]
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- 2015
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11. Peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis subsp. kurstaki strain PB 54.
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Cabrera, Luis Carrasco, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, Lentdecker, Chloe De, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
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BACILLUS thuringiensis serovar kurstaki ,RISK assessment ,RISK mitigation of pesticides ,STONE fruit ,BACILLUS thuringiensis - Abstract
The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Denmark, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance Bacillus thuringiensis subsp. kurstaki strain PB 54 and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of Bacillus thuringiensis subsp. kurstaki strain PB 54 as an insecticide on stone fruit and ornamentals (field uses) and tomato (field, permanent greenhouse and walk‐in tunnel uses). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
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- 2021
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12. Peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis subsp. kurstaki strain EG2348.
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Cabrera, Luis Carrasco, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
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BACILLUS thuringiensis ,RISK assessment ,PESTICIDES ,COMPETENT authority ,FOOD safety - Abstract
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Denmark, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance Bacillus thuringiensis subsp. kurstaki strain EG2348 and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of Bacillus thuringiensis kurstaki strain EG2348 as an insecticide on pome fruits (field use), solanaceous fruiting vegetables (uses in permanent greenhouse and walk‐in tunnel) and ornamentals (field, permanent greenhouse and walk‐in tunnel uses). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
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- 2021
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13. Peer review of the pesticide risk assessment of the active substance phosmet.
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Cabrera, Luis Carrasco, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
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RISK assessment ,PESTICIDES ,CITRUS fruits ,COMPETENT authority ,NECTARINE - Abstract
The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Spain, and co-rapporteur Member State, Greece, for the pesticide active substance phosmet and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of phosmet as an insecticide on citrus fruits, pome fruits, peaches/nectarines and potatoes (field uses). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
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- 2021
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14. Cumulative dietary risk assessment of chronic acetylcholinesterase inhibition by residues of pesticides.
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Anastassiadou, Maria, Choi, Judy, Coja, Tamara, Dujardin, Bruno, Hart, Andy, Hernandez‐Jerrez, Antonio F, Jarrah, Samira, Lostia, Alfonso, Machera, Kyriaki, Mangas, Iris, Mienne, Alexandra, Schepens, Marloes, Widenfalk, Anneli, and Mohimont, Luc
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PESTICIDE residues in food ,ACETYLCHOLINESTERASE ,RISK assessment ,RISK assessment of pesticides ,FOOD consumption - Abstract
A retrospective cumulative risk assessment of dietary exposure to pesticide residues was conducted for chronic inhibition of acetylcholinesterase. The pesticides considered in this assessment were identified and characterised in a previous scientific report on the establishment of cumulative assessment groups of pesticides for their effects on the nervous system. The exposure assessments used monitoring data collected by Member States under their official pesticide monitoring programmes in 2016, 2017 and 2018, and individual food consumption data from 10 populations of consumers from different countries and from different age groups. Exposure estimates were obtained by means of a two‐dimensional probabilistic model, which was implemented in SAS® software. The characterisation of cumulative risk was supported by an uncertainty analysis based on expert knowledge elicitation. For each of the 10 populations, it is concluded with varying degrees of certainty that cumulative exposure to pesticides contributing to the chronic inhibition of acetylcholinesterase does not exceed the threshold for regulatory consideration established by risk managers. [ABSTRACT FROM AUTHOR]
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- 2021
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15. Peer review of the pesticide risk assessment of the active substance Bacillus amyloliquefaciens strain QST 713 (formerly Bacillus subtilis strain QST 713).
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Cabrera, Luis Carrasco, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
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BACILLUS amyloliquefaciens ,BACILLUS subtilis ,RISK assessment ,PESTICIDES ,COMPETENT authority ,GRAPE seed extract - Abstract
The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Germany, and co-rapporteur Member State, Denmark, for the pesticide active substance Bacillus amyloliquefaciens strain QST 713, formerly Bacillus subtilis strain QST 713, are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of Bacillus amyloliquefaciens strain QST 713 as a fungicide on strawberry (field and greenhouse uses) and grapes (field use). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
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- 2021
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16. Peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis ssp. israelensis (serotype H‐14) strain AM65‐52.
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
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BACILLUS thuringiensis ,RISK assessment ,PESTICIDES ,ORNAMENTAL plants ,COMPETENT authority - Abstract
The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Sweden and co‐rapporteur Member State Spain for the pesticide active substance Bacillus thuringiensis ssp. israelensis (serotype H‐14) strain AM65‐52 and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative use of Bacillus thuringiensis ssp. israelensis (serotype H‐14) strain AM65‐52 as an insecticide on ornamental plants (permanent greenhouse production). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
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- 2020
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17. Peer review of the pesticide risk assessment of the active substance Pythium oligandrum strain M1.
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
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RISK assessment ,RAPESEED oil ,PYTHIUM ,PESTICIDES ,WHEAT ,OILSEEDS - Abstract
The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Sweden and co-rapporteur Member State Hungary for the pesticide active substance Pythium oligandrum strain M1 and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of Pythium oligandrum strain M1 as a fungicide on oil seed rape, wheat and spring barley (field use). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
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- 2020
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18. Peer review of the pesticide risk assessment of the active substance Beauveria bassiana strain 203.
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
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BEAUVERIA bassiana ,RISK assessment ,PESTICIDES ,DATE palm ,COMPETENT authority - Abstract
The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the Netherlands for the pesticide active substance Beauveria bassiana strain 203 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of Beauveria bassiana strain 203 as an insecticide on Phoenix canariensis (field use, indoor and greenhouse applications) and Phoenix dactylifera (field use) in southern Europe. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
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- 2020
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19. Peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis ssp. aizawai strain GC-91.
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
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BACILLUS thuringiensis ,RISK assessment ,PESTICIDES ,ORCHARDS ,COMPETENT authority ,GRAPE seed extract ,INSECTICIDES - Abstract
The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State The Netherlands and co-rapporteur Member State Germany for the pesticide active substance Bacillus thuringiensis ssp. aizawai strain GC-91 and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of Bacillus thuringiensis ssp. aizawai strain GC-91 as an insecticide on pome fruits (apple, pear), grapes and sports turf (field uses) and tomato (greenhouse uses). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
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- 2020
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20. Peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis ssp. aizawai strain ABTS‐1857.
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
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BACILLUS thuringiensis ,RISK assessment ,PESTICIDES ,INSECTICIDES ,COMPETENT authority - Abstract
The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State The Netherlands and co‐rapporteur Member State Germany for the pesticide active substance Bacillus thuringiensis ssp. aizawai strain ABTS‐1857 and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of Bacillus thuringiensis ssp. aizawai strain ABTS‐1857 as an insecticide on fruiting vegetables (pepper, field and greenhouse uses). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
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- 2020
- Full Text
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21. Peer review of the pesticide risk assessment of the active substance Metarhizium brunneum BIPESCO 5/F52.
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
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RISK assessment ,METARHIZIUM ,PESTICIDES ,TABLE grapes ,GRAPES - Abstract
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands, and co‐rapporteur Member State, France, for the pesticide active substance Metarhizium brunneumBIPESCO 5/F52 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of Metarhizium brunneumBIPESCO 5/F52 as an insecticide and acaricide on meadows, grassland, amenity turf, maize, wine and table grape, potato, allium vegetables (only field uses) and ornamentals (floriculture, tree nurseries and perennials), strawberry, currants and berries, solanaceae fruiting vegetables (field and greenhouse uses) and cucurbit fruiting vegetables (only greenhouse uses). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
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- 2020
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22. Peer review of the pesticide risk assessment of the active substance Bacillus thuringiensis subsp. kurstaki strain SA‐12.
- Author
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
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BACILLUS thuringiensis ,RISK assessment ,PESTICIDES ,FOOD safety ,INSECTICIDES - Abstract
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Denmark, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance Bacillus thuringiensis subsp. kurstaki strain SA‐12 and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of Bacillus thuringiensis subsp. kurstaki strain SA‐12 as an insecticide on pome fruits (field use), protected tomato (including permanent greenhouses and walk‐in tunnels) and ornamentals (field use). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
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- 2020
- Full Text
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23. Updated peer review of the pesticide risk assessment of the active substance flumioxazin.
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
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RISK assessment ,PESTICIDES ,WINTER wheat ,HERBICIDES ,COMPETENT authority - Abstract
The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, the Czech Republic, for the pesticide active substance flumioxazin are reported. The context of the peer review was that required by Commission Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013. The conclusions were reached on the basis of the evaluation of the representative uses of flumioxazin as a herbicide on winter wheat and sunflower (pre‐ and post‐emergence). The conclusions were updated with regard to the endocrine‐disrupting properties. The reliable end points concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
24. Peer review of the pesticide risk assessment for the active substance tri‐allate in light of confirmatory data submitted.
- Author
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
- Subjects
RISK assessment ,PESTICIDES ,HERBICIDES ,COMPETENT authority - Abstract
The conclusions of the EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, the United Kingdom, for the pesticide active substance tri‐allate are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data. The conclusions were reached on the basis of the evaluation of the representative uses of tri‐allate as a herbicide on cereals (barley and wheat). The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Concerns are identified. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
25. Peer review of the pesticide risk assessment of the active substance Purpureocillium lilacinum strain 251.
- Author
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
- Subjects
RISK assessment ,PESTICIDES ,COMPETENT authority ,PAECILOMYCES ,PEERS - Abstract
The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Hungary, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance Purpureocillium lilacinum strain 251, formerly called Paecilomyces lilacinus strain 251, are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of Purpureocillium lilacinum strain 251 as a biological nematicide on tomato and cucumber (uses in the field and permanent greenhouses). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
26. Peer review of the pesticide risk assessment of the active substance captan.
- Author
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
- Subjects
RISK assessment ,PESTICIDES ,NECTARINE ,PEACH ,FUNGICIDES - Abstract
The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Austria and co‐rapporteur Member State Italy for the pesticide active substance captan are reported and the confirmatory data following the Article 12 of Regulation (EC) No 396/2005 as well. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of captan as a fungicide on pome fruit, peaches and nectarines, plums, cherry, tomato, strawberries (field use) and strawberries (greenhouse application). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
27. Updated peer review of the pesticide risk assessment of the active substance cyazofamid.
- Author
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
- Subjects
RISK assessment ,PESTICIDES ,FUNGICIDES ,COMPETENT authority ,PEERS - Abstract
The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, France, and co‐rapporteur Member State, Latvia, for the pesticide active substance cyazofamid are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cyazofamid as a fungicide on potato, tomato and cucurbits and were updated for non‐target organisms. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
28. Updated peer review of the pesticide risk assessment for the active substance dithianon in light of confirmatory data submitted.
- Author
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
- Subjects
RISK assessment ,PESTICIDES ,TABLE grapes ,GRAPES ,COMPETENT authority - Abstract
The conclusions of the EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Greece, for the pesticide active substance dithianon are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory mammalian toxicology and residues data. The conclusions were reached on the basis of the evaluation of the representative uses of dithianon as a fungicide on table and wine grapes and on pome fruit. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Concerns are identified. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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- View/download PDF
29. EURL ECVAM status report on the development, validation and regulatory acceptance of alternative methods and approaches (2017)
- Author
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ZUANG VALERIE, VIEGAS BARROSO JOAO FILIPE, BELZ SUSANNE, BERGGREN ELISABET, BERNASCONI CAMILLA, BOPP STEPHANIE, BOUHIFD MOUNIR, BOWE GERARD, CAMPIA IVANA, CASATI SILVIA, COECKE SANDRA, CORVI RAFFAELLA, DURA ADELAIDE, GRIBALDO LAURA, GRIGNARD ELISE, HALDER MARIA ELISABETH, HOLLEY TRACEY, JANUSCH ROI ANNETT, KIENZLER AUDE, LOSTIA ALFONSO, MADIA FEDERICA, MILCAMPS ANNE, MORATH SIEGFRIED, MUNN SHARON, PAINI ALICIA, PISTOLLATO FRANCESCA, PRICE ANNA, PRIETO PERAITA MARIA DEL PILAR, RICHARZ ANDREA, TRIEBE JUTTA, VAN DER LINDEN SANDER, WORTH ANDREW, WITTWEHR CLEMENS, and WHELAN MAURICE
- Abstract
Every year, EURL ECVAM prepares a Status Report with the primary purpose of which is to inform its stakeholders and all interested parties (the public, press etc.) on updates on the status of alternative methods and approaches. The EURL ECVAM status report provides updates on activities since the last report published in October 2016. It reports on research and development, validation activities as well as on activities which promote the regulatory and international adoption and use of alternative approaches and their dissemination. It describes primarily, but not exclusively, all the activities that EURL ECVAM has undertaken or has been involved in since the publication of the last report., JRC.F.3-Chemicals Safety and Alternative Methods
- Published
- 2017
30. Peer review of the pesticide risk assessment of the active substance abamectin.
- Author
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Cabrera, Luis Carrasco, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
- Subjects
ABAMECTIN ,PESTICIDES ,RISK assessment ,INSECTICIDES ,FOOD safety - Abstract
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Austria, and co-rapporteur Member State, Malta, for the pesticide active substance abamectin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of abamectin as an insecticide and acaricide on tomato and strawberry. The reliable end points appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
31. Peer review of the pesticide risk assessment of the active substance aqueous extract from the germinated seeds of sweet Lupinus albus.
- Author
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Alvarez, Fernando, Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, and Lostia, Alfonso
- Subjects
LUPINUS albus ,RISK assessment ,PESTICIDES ,SEEDS ,FOOD safety - Abstract
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, the Netherlands, for the pesticide active substance aqueous extract from the germinated seeds of sweet Lupinus albus and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of the aqueous extract from the germinated seeds of sweet Lupinus albus as a fungicide on strawberry and tomatoes (field use and greenhouse application). The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns were not identified. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
32. Peer review of the pesticide risk assessment of the active substance Streptomyces strain K61.
- Author
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
- Subjects
STREPTOMYCES ,RISK assessment ,PESTICIDES ,ROOT crops ,EDIBLE greens - Abstract
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Estonia, and co‐rapporteur Member State, France, for the pesticide active substance Streptomyces strain K61 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative use of Streptomyces strain K61 as a fungicide on fruiting vegetables, leafy vegetables, bulb vegetables, pulses, ornamentals, aromatic herbs and root crops, onions and seedlings, in permanent greenhouses and walk‐in tunnels. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
33. Peer review of the pesticide risk assessment of the active substance Bacillus amyloliquefaciens strain AH2.
- Author
-
Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, and Lythgo, Christopher
- Subjects
BACILLUS amyloliquefaciens ,RISK assessment ,PESTICIDES ,FUNGICIDES ,COMPETENT authority - Abstract
The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the Netherlands for the pesticide active substance Bacillus amyloliquefaciens strain AH2 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of Bacillus amyloliquefaciens AH2 as a fungicide on grapes. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
34. Peer review of the pesticide risk assessment of the active substance 24‐epibrassinolide.
- Author
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Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Marques, Daniele Court, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, and Lostia, Alfonso
- Abstract
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Austria, for the pesticide active substance 24‐epibrassinolide and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of 24‐epibrassinolide as an elicitor on grapes, leafy vegetables, sugar beet and as plant activator on grapes and cucurbits. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. No concerns are identified. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
35. Draft framework for protocol development for EFSA's scientific assessments.
- Author
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Martino, Laura, Aiassa, Elisa, Halldórsson, ÞórhallurIngi, Koutsoumanis, Konstantinos Panagiotis, Naegeli, Hanspeter, Baert, Katleen, Baldinelli, Francesca, Devos, Yann, Lodi, Federica, Lostia, Alfonso, Manini, Paola, Merten, Caroline, Messens, Winy, Rizzi, Valentina, Tarazona, Jose, Titz, Ariane, and Vos, Sybren
- Subjects
METHODOLOGY - Abstract
During 2014‐2018, EFSA defined a series of principles for the scientific assessment process (impartiality, methodological rigour, transparency and engagement) and developed a 4‐stepapproach (plan/do/verify/report)to facilitate their fulfilment. According to the approach, the methods for the scientific assessmentmust be planned upfront in aprotocol to prevent data‐driven decisions and to increase rigour and transparency of the process.Following the decision to gradually implement the 4‐step approach in all EFSA's non‐application scientific assessments, it was deemed necessary to set up recommendations for protocol development. This technical report provides these recommendations. The document is published as a draftbecause the framework for protocol development will be tested in EFSA's non‐application assessmentsover a one‐yearperiod and revised accordingly. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
36. Peer review of the pesticide risk assessment of the active substance ferric pyrophosphate.
- Author
-
Anastassiadou, Maria, Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Marques, Daniele Court, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, and Lostia, Alfonso
- Subjects
RISK assessment ,PESTICIDES ,COMPETENT authority ,FOOD safety ,PEERS - Abstract
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Poland for the pesticide active substance ferric pyrophosphate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of ferric pyrophosphate as a molluscicide on all edible and inedible crops. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
37. Preliminary study to characterise the metabolic competence of in vitro cellular systems
- Author
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ZORZOLI MARIA CHIARA, MENDOZA EMILIO, MORATH Siegfried, COECKE Sandra, and LOSTIA ALFONSO
- Abstract
The purpose of this report is to describe the experimental procedure used to perform a preliminary study to characterise the metabolic competence of in vitro cellular systems. As a first study, the metabolic competence was assessed by monitoring the presence of four specific enzymes by using selected probe substrates. Each probe substrate can be metabolised by only one enzyme and therefore the formation over time of metabolites is indicative for the presence of a certain enzyme. The concentrations of each metabolite over-time were measured by using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS). The method developed to monitor the presence of the four enzymes was then used to compare the metabolic competence between two cellular systems: HepaRG (human liver cells known to be metabolically competent) and AR-CALUX (human osteoblastic osteosarcoma U2-OS cells having low or none metabolic activity). The results and experience achieved will serve to ultimately support the planned work of Directorate F3 focused on developing an EURL ECVAM recommendation, which will be followed by an OECD Guidance Document, with the objective to characterise and describe in vitro hepatic metabolic clearance methods in order to facilitate their regulatory uptake and use to support chemical risk assessment., JRC.F.3-Chemicals Safety and Alternative Methods
- Published
- 2016
38. Development of an in vitro metabolic hepatic clearance method
- Author
-
LOSTIA ALFONSO, ZORZOLI MARIA CHIARA, FORTANER TORRENT Salvador, MENDOZA EMILIO, BOUHIFD Mounir, and COECKE Sandra
- Abstract
There is increasing demand from in vitro method developers, validation bodies, in vitro method end-users as well as receiving authorities and OECD to integrate kinetics information in toxicity testing in order to improve chemical risk assessment. A strategic way to do this is detailed in the "EURL ECVAM strategy for achieving 3Rs impact in the assessment of toxicokinetics and systemic toxicity" (Bessems J et al. 2015). One of the strategic aims of this report urges for the development and applied use of in vitro kinetic methods for absorption, distribution, metabolism and excretion to be used in the future risk assessment approaches using new advanced methodologies (NAMs). Information on metabolism has been identified as a critical piece of information in integrated test strategies based on non-animal methods. Therefore, the purpose of this report is to describe the preliminary experimental work towards a representative in vitro human hepatic metabolic clearance method that can be ultimately used in future defined approaches for toxicological risk assessment. The proposed method is a result of the efforts of the EURL ECVAM laboratory team combined with knowledge gathered during (1) a literature search on in vitro human hepatic metabolic clearance methods, (2) an EURL ECVAM call for procedures detailing in vitro human hepatic metabolic clearance methods and (3) an expert meeting to establish the elements critical for in vitro methods that predict human hepatic metabolic clearance. The representative in vitro human hepatic metabolic clearance method was used to assess the in vitro intrinsic clearance of the following three chemicals: Acetaminophen, Diclofenac and Verapamil. Each chemical was added at one concentration to cryopreserved primary human hepatocytes (pooled from 10 donors) and the cells were exposed at different incubation time-points up to 2 h. The concentrations of each chemical over-time were measured by using Ultra-Performance Liquid-Chromatography (UPLC) coupled with (Quadrupole Time-of-Flight) Q-Tof mass spectrometer. The results obtained show good within-laboratory reproducibility (e.g. between different runs on different days), of the calculated in vitro intrinsic clearance. The results and experience gained with this experimental in-house effort by Directorate F – Health, Consumers and Reference Materials, F.3 Chemicals Safety and Alternative Methods will support the definition of an EURL ECVAM recommendation on human hepatic metabolic clearance and the subsequent drafting of a proposal for an OECD Guidance Document with the objective to characterise and describe in vitro hepatic metabolic clearance methods in order to facilitate their regulatory uptake and use to support chemical risk assessment., JRC.F.3-Chemicals Safety and Alternative Methods
- Published
- 2016
39. Modification of the existing maximum residue level for clothianidin in potatoes.
- Author
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European Food Safety Authority (EFSA), Brancato, Alba, Brocca, Daniela, Carrasco Cabrera, Luis, De Lentdecker, Chloe, Erdos, Zoltan, Ferreira, Lucien, Greco, Luna, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, Lythgo, Christopher, Medina, Paula, Miron, Ileana, Molnar, Tunde, Pedersen, Ragnor, Reich, Hermine, Sacchi, Angela, and Santos, Miguel
- Subjects
CLOTHIANIDIN ,THIAMETHOXAM ,PESTICIDES ,POTATOES - Abstract
Abstract: In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are available to control clothianidin residues on the commodity under consideration. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of clothianidin according to the notified agricultural practice in Canada is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]
- Published
- 2018
- Full Text
- View/download PDF
40. Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005.
- Author
-
European Food Safety Authority (EFSA), Brancato, Alba, Brocca, Daniela, Carrasco Cabrera, Luis, De Lentdecker, Chloe, Erdos, Zoltan, Ferreira, Lucien, Greco, Luna, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, Lythgo, Christopher, Medina, Paula, Miron, Ileana, Molnar, Tunde, Pedersen, Ragnor, Reich, Hermine, Sacchi, Angela, and Santos, Miguel
- Subjects
HERBICIDES ,PESTICIDES ,TURNIPS ,POTATOES - Abstract
Abstract: According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]
- Published
- 2018
- Full Text
- View/download PDF
41. Modification of the existing maximum residue levels for flonicamid in various root crops.
- Author
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European Food Safety Authority (EFSA), Brancato, Alba, Brocca, Daniela, Carrasco Cabrera, Luis, De Lentdecker, Chloe, Erdos, Zoltan, Ferreira, Lucien, Greco, Luna, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, Lythgo, Christopher, Medina, Paula, Miron, Ileana, Molnar, Tunde, Pedersen, Ragnor, Reich, Hermine, Sacchi, Angela, and Santos, Miguel
- Subjects
TURNIPS ,CARROTS ,PESTICIDES ,POTATOES - Abstract
Abstract: In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, turnips. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the commodities concerned. Adequate analytical methods for enforcement are available to control the residues of flonicamid in the crops under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg for each analyte of the residue definition and in animal matrices at the validated LOQ of 0.01 mg/kg for each analyte of the residue definition. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of flonicamid according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]
- Published
- 2018
- Full Text
- View/download PDF
42. Modification of the existing maximum residue level for flonicamid in various crops.
- Author
-
European Food Safety Authority (EFSA), Brancato, Alba, Brocca, Daniela, De Lentdecker, Chloe, Erdos, Zoltan, Ferreira, Lucien, Greco, Luna, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, Lythgo, Christopher, Medina, Paula, Miron, Ileana, Molnar, Tunde, Pedersen, Ragnor, Reich, Hermine, Sacchi, Angela, Santos, Miguel, and Stanek, Alois
- Subjects
STRAWBERRIES ,BLACKBERRIES ,RASPBERRIES ,PESTICIDES ,HOST plants - Abstract
Abstract: In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Netherlands to modify the existing MRLs for the active substance flonicamid in strawberries, cane fruits, other small fruits and berries, lettuces and other salad plants, and pulses (dry beans, lentils, peas, lupins). The data submitted in support of the request were found to be sufficient to derive MRL proposals for strawberries, blackberries, raspberries, other small fruits and berries, radishes, lettuces and other salad plants, and pulses (dry beans, lentils, peas and lupins). Adequate analytical methods for enforcement are available to control the residues of flonicamid on in the commodities under consideration. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of flonicamid according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]
- Published
- 2018
- Full Text
- View/download PDF
43. Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005.
- Author
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European Food Safety Authority (EFSA), Brancato, Alba, Brocca, Daniela, Carrasco Cabrera, Luis, De Lentdecker, Chloe, Erdos, Zoltan, Ferreira, Lucien, Greco, Luna, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, Lythgo, Christopher, Medina, Paula, Miron, Ileana, Molnar, Tunde, Pedersen, Ragnor, Reich, Hermine, Riemenschneider, Christina, and Sacchi, Angela
- Subjects
FLUQUINCONAZOLE ,FUNGICIDES ,PESTICIDES ,HOST plants ,DATA extraction - Abstract
Abstract: According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active substance. Therefore, residues of fluquinconazole are not expected to occur in any plant or animal commodity. Nevertheless, available data allowed EFSA to propose a marker residue and limit of quantifications (LOQs) for enforcement against potential illegal uses. [ABSTRACT FROM AUTHOR]
- Published
- 2018
- Full Text
- View/download PDF
44. Adverse outcome pathway development from protein alkylation to liver fibrosis
- Author
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Horvat, Tomislav, primary, Landesmann, Brigitte, additional, Lostia, Alfonso, additional, Vinken, Mathieu, additional, Munn, Sharon, additional, and Whelan, Maurice, additional
- Published
- 2016
- Full Text
- View/download PDF
45. Modification of the existing maximum residue levels for imazalil in various commodities.
- Author
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European Food Safety Authority (EFSA), Brancato, Alba, Brocca, Daniela, Carrasco Cabrera, Luis, Chiusolo, Arianna, Civitella, Consuelo, Court Marques, Daniele, Crivellente, Federica, De Lentdecker, Chloe, Erdos, Zoltan, Ferreira, Lucien, Greco, Luna, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, Lostia, Alfonso, Lythgo, Christopher, Medina, Paula, and Mineo, Desire
- Subjects
IMAZALIL ,FUNGICIDE residues in food ,FOOD safety ,RISK assessment ,PLANT metabolites - Abstract
Abstract: In accordance with Article 6 of Regulation (EC) No 396/2005, the Imazalil Task Force submitted a request to the competent national authority in the Netherlands to change the existing maximum residue levels (MRLs) for the active substance imazalil in products of plant and animal origin. The evaluating Member State (EMS) proposed to modify the existing MRLs only in citrus fruits and bananas and, due to transfer of residues, in bovine and equine livers. EFSA assessed the intended uses in citrus fruits, but not the use in bananas, since compared with the previously performed MRL review no new information was provided in the context of the MRL application. For the intended uses in citrus fruits and for animal products, EFSA did not derive MRL proposals. A decision on the amendment of MRL for the intended uses needs to be postponed, until the risk assessment for the plant metabolite R014821 and for the metabolites identified in livestock (i.e. FK‐772 and FK‐284) is completed with regard to genotoxicity and general toxicity; data need to be provided to derive a conclusion whether the toxicological reference values derived for imazalil are also applicable for the metabolites. Upon conclusion on the toxicological properties of the metabolites, a decision on the residue definition for risk assessment cannot be derived which is a prerequisite to perform a reliable dietary risk assessment. [ABSTRACT FROM AUTHOR]
- Published
- 2018
- Full Text
- View/download PDF
46. Running an unknown risk: a marathon death associated with the use of 1,3-dimethylamylamine (DMAA)
- Author
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Archer, John R.H., primary, Dargan, Paul I., additional, Lostia, Alfonso M., additional, van der Walt, Jon, additional, Henderson, Katherine, additional, Drake, Nicola, additional, Sharma, Sanjay, additional, Wood, David M., additional, Walker, Christopher J., additional, and Kicman, Andrew T., additional
- Published
- 2015
- Full Text
- View/download PDF
47. Asthma And Intestinal Permeability In Children: Role Of Age, Symptoms And Allergen Sensitization
- Author
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Barreto, Mario, primary, Simmaco, Maurizio, additional, Principessa, Luigi, additional, Lostia, Alfonso, additional, Zambardi, Rosanna, additional, Bonafoni, Susanna, additional, Negro, Valentina, additional, Olita, Carla, additional, and Villa, Maria P., additional
- Published
- 2010
- Full Text
- View/download PDF
48. A Liquid Chromatography-Tandem Mass Spectrometry Method for the Determination of 5-Fluorouracil Degradation Rate by Intact Peripheral Blood Mononuclear Cells
- Author
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Lostia, Alfonso M, primary, Lionetto, Luana, additional, Ialongo, Cristiano, additional, Gentile, Giovanna, additional, Viterbo, Antonella, additional, Malaguti, Paola, additional, Paris, Ida, additional, Marchetti, Luca, additional, Marchetti, Paolo, additional, Blasi, Antonio De, additional, and Simmaco, Maurizio, additional
- Published
- 2009
- Full Text
- View/download PDF
49. Serum Levels of Risperidone and Its Metabolite, 9-Hydroxyrisperidone: Correlation Between Drug Concentration and Clinical Response
- Author
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Lostia, Alfonso M, primary, Mazzarini, Lorenzo, additional, Pacchiarotti, Isabella, additional, Lionetto, Luana, additional, Rossi, Pietro De, additional, Sanna, Livia, additional, Sani, Gabriele, additional, Kotzalidis, Giorgio D, additional, Girardi, Paolo, additional, Simmaco, Maurizio, additional, and Tatarelli, Roberto, additional
- Published
- 2009
- Full Text
- View/download PDF
50. Peer review of the pesticide risk assessment of the active substance benfluralin.
- Author
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Arena, Maria, Auteri, Domenica, Brancato, Alba, Bura, Laszlo, Carrasco Cabrera, Luis, Chaideftou, Eugenia, Chiusolo, Arianna, Court Marques, Daniele, Crivellente, Federica, De Lentdecker, Chloe, Egsmose, Mark, Fait, Gabriella, Ferreira, Lucien, Greco, Luna, Ippolito, Alessio, Istace, Frederique, Jarrah, Samira, Kardassi, Dimitra, Leuschner, Renata, and Lostia, Alfonso
- Subjects
RISK assessment ,PESTICIDES ,HERBICIDES ,COMPETENT authority ,CHICORY - Abstract
The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Norway, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance benfluralin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of benfluralin as a herbicide on chicory and lettuce. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]
- Published
- 2019
- Full Text
- View/download PDF
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