401 results on '"Nave, S."'
Search Results
52. The Application of 57FE Mössbauer Spectroscopy to the Characterization of Nuclear Waste Forms.
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Huray, Paul G., Spaar, M. T., Nave, S. E., Legan, J. M., Boatner, L. A., and Abraham, M. M.
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- 1981
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53. Polarized Raman spectra of single-crystal lanthanide oxychlorides
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Cul, G. D. Del, Nave, S. E., and Peterson, J. R.
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- 1993
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54. Improved method for determining tank heel volumes
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Nave, S
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- 1994
55. Solid-state, resistive hydrogen sensors for safety monitoring
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Nave, S [Westinghouse Savannah River Co., Aiken, SC (United States)]
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- 1993
56. Characterization of DNAPL Using Fluorescence Techniques
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Nave, S
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- 1998
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57. General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy
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Adam P. Hill, Zhen Song, Haibo Ni, Norman Stockbridge, David G. Strauss, Jamie I. Vandenberg, Todd Wisialowski, Mikiko Nakamura, Takashi Yoshinaga, Godfrey L. Smith, Jill Steidl‐Nichols, Mark Holbrook, Stefano Severi, Pierre Morissette, Derek J. Leishman, Colleen E. Clancy, Gary R. Mirams, Andrea Greiter-Wilke, Andrew G. Edwards, Xiaomei Han, Zhihua Li, Flora Musuamba Tshinanu, Stefano Morotti, Stephane Nave, Aaron Fullerton, Bradley J. Ridder, Zhilin Qu, Michelangelo Paci, Alfonso Bueno-Orovio, Janell E. Chen, Thomas Singer, Peter R. Kowey, Liudmila Polonchuk, Eric A. Sobie, Blanca Rodriguez, Randall L. Rasmusson, Elisa Passini, Eleonora Grandi, Ken Wang, Michael Liu, Bruce P. Damiano, Xin Zhou, Li Z., Mirams G.R., Yoshinaga T., Ridder B.J., Han X., Chen J.E., Stockbridge N.L., Wisialowski T.A., Damiano B., Severi S., Morissette P., Kowey P.R., Holbrook M., Smith G., Rasmusson R.L., Liu M., Song Z., Qu Z., Leishman D.J., Steidl-Nichols J., Rodriguez B., Bueno-Orovio A., Zhou X., Passini E., Edwards A.G., Morotti S., Ni H., Grandi E., Clancy C.E., Vandenberg J., Hill A., Nakamura M., Singer T., Polonchuk L., Greiter-Wilke A., Wang K., Nave S., Fullerton A., Sobie E.A., Paci M., Musuamba Tshinanu F., Strauss D.G., Tampere University, BioMediTech, and Research group: Computational Biophysics and Imaging Group
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Drug-Related Side Effects and Adverse Reactions ,none ,In silico ,White Paper ,Harmonization ,Context (language use) ,Arrhythmias ,Validation Studies as Topic ,Risk prediction models ,Risk Assessment ,030226 pharmacology & pharmacy ,Session (web analytics) ,03 medical and health sciences ,0302 clinical medicine ,Consistency (negotiation) ,White paper ,Theoretical ,Models ,medicine ,Humans ,Computer Simulation ,Pharmacology (medical) ,Pharmacology & Pharmacy ,Pharmacology ,Proarrhythmia ,Management science ,Arrhythmias, Cardiac ,217 Medical engineering ,Pharmacology and Pharmaceutical Sciences ,Models, Theoretical ,medicine.disease ,030220 oncology & carcinogenesis ,Cardiac - Abstract
This white paper presents principles for validating proarrhythmia risk prediction models for regulatory use as discussed at the In Silico Breakout Session of a Cardiac Safety Research Consortium/Health and Environmental Sciences Institute/US Food and Drug Administration–sponsored Think Tank Meeting on May 22, 2018. The meeting was convened to evaluate the progress in the development of a new cardiac safety paradigm, the Comprehensive in Vitro Proarrhythmia Assay (CiPA). The opinions regarding these principles reflect the collective views of those who participated in the discussion of this topic both at and after the breakout session. Although primarily discussed in the context of in silico models, these principles describe the interface between experimental input and model‐based interpretation and are intended to be general enough to be applied to other types of nonclinical models for proarrhythmia assessment. This document was developed with the intention of providing a foundation for more consistency and harmonization in developing and validating different models for proarrhythmia risk prediction using the example of the CiPA paradigm.
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- 2019
58. Magnetic susceptibility of californium fluorides
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Nave, S [Department of Physics, University of Tennessee, Knoxville, Tennessee 37996-1200 (USA)]
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- 1990
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59. Calculator thermometer
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Nave, S.
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- 1979
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60. Magnetic measurements of the transuranium elements. Progress report, January 1-December 31, 1986
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Nave, S
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- 1986
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61. Thin-film fiber optic hydrogen and temperature sensor system
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Nave, S
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- 1998
62. Magnetic measurements of the transuranium elements: Progress report, January 1, 1985-December 31, 1987
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Nave, S
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- 1987
63. Magnetic measurements of the transuranium elements. Progress report, January 1, 1984-December 31, 1984
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Nave, S
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- 1984
64. Magnetic measurements of the transuranium elements: Progress report, January 1, 1988-December 31, 1988
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Nave, S
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- 1988
65. Modification of the existing maximum residue levels for picloram in animal commodities and honey.
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Bellisai G, Bernasconi G, Cabrera LC, Castellan I, Del Aguila M, Ferreira L, Greco L, Jarrah S, Leuschner R, Mioč A, Nave S, Reich H, Ruocco S, Scarlato AP, Szot M, Theobald A, Tiramani M, Verani A, and Zioga E
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Corteva Agriscience International Sàrl submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) in certain animal commodities (fat and liver) and honey. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for honey. Adequate analytical methods for enforcement are available to control the residues according to the residue definition for enforcement proposed as 'picloram, free and conjugated, expressed as picloram' in honey at the validated limit of quantification (LOQ) of 0.01 mg/kg. For the commodities of animal origin, although the submitted data were found to be sufficient, EFSA concluded that no change of the existing MRLs was necessary. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues expected in honey, resulting from the existing uses of picloram on melliferous crops, is unlikely to present a risk to consumer health., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2024
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66. Modification of the existing maximum residue level for flonicamid in honey.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Greco L, Jarrah S, Leuschner R, Mioč A, Nave S, Reich H, Ruocco S, Scarlato AP, Szot M, Taglianini E, Theobald A, Tiramani M, and Verani A
- Abstract
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 Finland to modify the existing maximum residue level (MRL) for the active substance flonicamid in honey. The data submitted in support of the request were not found appropriate to derive an MRL proposal for honey. The assessment was complemented by an analysis of the monitoring data available from the EU monitoring programmes (conducted during 2009-2023). The results from the monitoring data analysis suggest that the current MRL is still sufficient to account for the residue uptake in honey resulting from plant protection products uses of flonicamid on melliferious crops. Adequate analytical methods for enforcement are available to control the residues of flonicamid in honey according to the residue definition as the sum of flonicamid, TFNA and TFNG, expressed as flonicamid at the validated limit of quantification (LOQ) of 0.01 mg/kg for each compound. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues in honey at a level of 0.05 mg/kg according to the monitoring data is unlikely to present a risk to consumer health., 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.)
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- 2024
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67. Modification of the existing maximum residue levels for dichlorprop-P in cereal grains.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Greco L, Jarrah S, Leuschner R, Mioč A, Nave S, Reich H, Ruocco S, Scarlato AP, Szot M, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nufarm Crop Products UK Ltd. submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance dichlorprop-P in barley, oat, rye and wheat grain. The data submitted in support of the request were found to be sufficient to derive MRL proposals for these cereal grains. Adequate analytical methods for enforcement are available to control the residues of dichlorprop-P in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg and in animal matrices at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, the European Food Safety Authority (EFSA) concluded that the short-term and long-term intake of residues resulting from the use of dichlorprop-P-2-ethylhexyl (dichlorprop-P 2-EHE) according to the reported agricultural practices is unlikely to present a risk to consumer health., 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.)
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- 2024
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68. Modification of the existing maximum residue levels for cycloxydim in various crops.
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Bellisai G, Bernasconi G, Cabrera LC, Castellan I, Del Aguila M, Ferreira L, Greco L, Jarrah S, Leuschner R, Mioč A, Nave S, Reich H, Ruocco S, Scarlato AP, Szot M, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance cycloxydim in pome fruits, apricots/peaches, peas (with pods), maize/corn, sugar beet roots and milk (sheep). The data submitted in support of the request were found to be sufficient to derive MRL proposals for pome fruits, peas (with pods), maize/corn and sugar beet roots while for apricots, peaches and sheep milk no changes to the existing MRLs were considered necessary. Adequate analytical methods for enforcement are available to control the residues of cycloxydim according to the current enforcement residue definition 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 uses of cycloxydim according to the reported agricultural practices is unlikely to present a risk to consumer health., 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.)
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- 2024
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69. Review of the existing maximum residue levels for difenoconazole according to Article 12 of Regulation (EC) No 396/2005.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Greco L, Jarrah S, Leuschner R, Mioč A, Nave S, Reich H, Ruocco S, Scarlato AP, Szot M, Theobald A, Tiramani M, and Verani A
- 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 difenoconazole. To assess the occurrence of difenoconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Council Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States and the UK (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. Some information required by the regulatory framework was missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered., 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.)
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- 2024
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70. Modification of the existing maximum residue level for methoxyfenozide in aubergines.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Greco L, Jarrah S, Leuschner R, Mioč A, Nave S, Reich H, Ruocco S, Scarlato AP, Szot M, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request on behalf of Belgium (evaluating Member State, EMS) to modify the existing maximum residue level (MRL) for the active substance methoxyfenozide in aubergines/eggplants. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for aubergines/eggplants. Adequate analytical methods for enforcement are available to control the residues of methoxyfenozide in the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, the EFSA concluded that the short-term and long-term intake of residues resulting from the indoor use of methoxyfenozide according to the reported agricultural practice is unlikely to present a risk to consumer health., 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.)
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- 2024
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71. Modification of the existing maximum residue levels in various plant commodities resulting from the use of potassium phosphonates.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Greco L, Jarrah S, Leuschner R, Mioč A, Nave S, Reich H, Ruocco S, Scarlato AP, Szot M, Theobald A, Tiramani M, and Verani A
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In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants De Sangosse SAS and Tilco-Alginure submitted two requests, respectively, to the competent national authorities in France and Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in various plant commodities. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for the commodities under assessment. For the derived MRL on baby leaf crops, further risk manager consideration is required to decide between two MRL options. Adequate analytical methods for enforcement are available to control the residues of potassium phosphonates in accordance with the residue definition 'phosphonic acid and its salts expressed as phosphonic acid' in the commodities under consideration. Based on the risk assessment results and assuming that the existing MRLs will be amended as proposed by EFSA in previous outputs, EFSA concluded that the long-term intake of residues resulting from the existing uses of fosetyl and phosphonates (previously assessed in a joint MRL review) and new proposed uses of potassium phosphonates is unlikely to present a risk to consumer health. Considering the toxicological profile of the active substance, a short-term dietary risk assessment was not required. The risk assessment shall be regarded as indicative because some MRL proposals derived by EFSA in the framework of the MRL review according to Articles 12 and 43 of Regulation (EC) No 396/2005 require further consideration by risk managers., 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.)
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- 2024
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72. Review of the existing maximum residue levels for gamma-cyhalothrin according to Article 12 of Regulation (EC) No 396/2005.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Greco L, Jarrah S, Leuschner R, Mioč A, Nave S, Reich H, Ruocco S, Scarlato AP, Szot M, Theobald A, Tiramani M, and Verani A
- 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 gamma-cyhalothrin. To assess the occurrence of gamma-cyhalothrin 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 European authorisations reported by Member States (including the supporting residues data) in the framework of this review. Based on the assessment of the available data, MRL proposals were derived, and a consumer risk assessment was carried out. Although no risk to consumers was identified, some information required by the regulatory framework was missing. The residue definition for monitoring (lambda-cyhalothrin (includes gamma-cyhalothrin) (sum of R, S and S, R isomers)) covers both lambda- and gamma-cyhalothrin. Appropriate enantioselective techniques, which are not commonly used in routine analysis, are required to differentiate gamma-cyhalothrin residues from lambda-cyhalothrin. According to the available data, it is expected that the MRLs currently set in Regulation (EC) No 396/2005 will cover the uses of gamma-cyhalothrin assessed in the present review. Therefore, risk managers can consider maintaining the existing EU MRLs., 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.)
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- 2024
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73. Evaluation of confirmatory data following the Article 12 MRL review for myclobutanil.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Mioč A, Nave S, Pedersen R, Reich H, Ruocco S, Scarlato AP, Szot M, Theobald A, Tiramani M, and Verani A
- Abstract
The applicant Corteva Agriscience submitted a request to the competent national authority in Austria to evaluate the confirmatory data that were identified for myclobutanil in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gap related to the lack of information on the triazole derivative metabolites (TDMs), new residue trials analysing for TDMs were submitted on apples, grapes, strawberries, tomatoes and melons. Following the assessment of the submitted data, EFSA concluded that Article 12 confirmatory data gaps are considered addressed for pome fruits, grapes, cucurbits with inedible peel, strawberries and tomatoes. The new information provided required the assessment of consumer exposure to TDMs, which identified no consumer intake concerns for the crops under consideration. No information was provided to address the Article 12 confirmatory data referred to in Regulation (EU) 2020/770 for blackberries, gooseberries, bananas, aubergines/eggplants, lamb's lettuces/corn salads, beans (with pods), globe artichokes, hops, sugar beet roots and products of animal origin. For these commodities, the existing EU MRL could be lowered to the enforcement limit of quantification (LOQ). For kaki/Japanese persimmon and azararoles/mediterranean medlars, the existing EU MRL is set on the basis of Codex MRL in pome fruits. The applicant did not request maintaining a Codex MRL in these commodities, but should risk managers decide otherwise, the Article 12 data gap is considered addressed for kaki/Japanese persimmon while for azaroles/Mediterranean medlars, a risk management decision might be required. No consumer intake concerns were identified., 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.)
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- 2024
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74. Modification of the existing maximum residue levels for fluxapyroxad in kaki/Japanese persimmons and cultivated mushrooms.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Mioč A, Nave S, Pedersen R, Reich H, Ruocco S, Scarlato AP, Szot M, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Spain and Ireland to modify the existing maximum residue levels (MRLs) for the active substance fluxapyroxad in kaki/Japanese persimmons and in cultivated fungi, respectively. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for kaki/Japanese persimmons and cultivated fungi. Adequate analytical methods for enforcement are available to control the residues of fluxapyroxad on the commodities under consideration at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of fluxapyroxad, according to the reported agricultural practices, is unlikely to present a risk to consumer health. The long-term consumer risk assessment is indicative, pending the submission of the confirmatory data requested under the MRL review., 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.)
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- 2024
- Full Text
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75. Evaluation of confirmatory data following the Article 12 MRL review for quizalofop-P-ethyl, quizalofop-P-tefuryl and propaquizafop and modification of the existing maximum residue levels for quizalofop-P-tefuryl.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Mioč A, Nave S, Pedersen R, Reich H, Ruocco S, Scarlato AP, Szot M, Theobald A, Tiramani M, and Verani A
- Abstract
The applicant Arysta Life Science Great Britain Limited submitted a request to the competent national authority in Croatia to evaluate the confirmatory data that were identified for quizalofop-P-tefuryl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. Since Article 12 data gaps were also set for the two other quizalofop-P variants sharing the same residue definitions for risk assessment and monitoring, EFSA included in the present assessment all quizalofop-P variants: quizalofop-P-ethyl, quizalofop-P-tefuryl and propaquizafop. Moreover, in the application submitted to Croatia, the applicant also included a request to modify the existing MRLs for quizalofop-P-tefuryl in grapes, sunflower seeds and soyabeans in accordance with Article 6 of Regulation (EC) No 396/2005. To address the data gaps, new data on hydrolysis efficiency of quizalofop-P-tefuryl, quizalofop acid, quizalofop-pentanoic acid and quizalofop-P-glycerate in different matrices of animal origin in accordance with the guidance document SANTE/2020/12830 Rev.1 were submitted, along with a validated analytical method for animal commodities. EFSA concluded that the data gap on validation of the efficiency of the extraction and hydrolysis included in the enforcement method of residues in livestock animal commodities was only fully addressed for muscle, poultry liver and eggs. Regarding plant commodities, the remaining data gaps were not addressed. EFSA also considered data gaps for quizalofop-p-ethyl in caraway as sufficiently addressed in the context of a previous MRL application. In general, the new information provided required a revision of the existing MRLs for several commodities of plant and animal origin. Further risk management considerations are required. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of quizalofop-P-tefuryl according to the reported agricultural practices is unlikely to present a risk to consumer health., 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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76. Updated reasoned opinion on the toxicological properties and maximum residue levels (MRLs) for the benzimidazole substances carbendazim and thiophanate-methyl.
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Bellisai G, Bernasconi G, Binaglia M, Carrasco Cabrera L, Castellan I, Castoldi AF, Chiusolo A, Crivellente F, Del Aguila M, Ferreira L, Giner Santonja G, Greco L, Istace F, Jarrah S, Lanzoni A, Leuschner R, Mangas I, Mioč A, Nave S, Panzarea M, Parra Morte JM, Pedersen R, Reich H, Ruocco S, Scarlato AP, Szot M, Terron A, Theobald A, Tiramani M, and Verani A
- Abstract
In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received from the European Commission in 2020 a mandate to provide its reasoned opinion on the toxicological properties and maximum residue levels (MRLs) for the benzimidazole substances carbendazim and thiophanate-methyl. Specifically, EFSA was asked to assess whether thiophanate-methyl or carbendazim has clastogenic potential and, in case clastogenic potential can be excluded, to derive toxicological reference values necessary for consumer risk assessment and assessment of maximum residue levels (MRLs). Although these active substances are no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs), and import tolerances are in place. Based on the assessment of the available data, toxicological reference values and MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment was considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers. In October 2022, to ensure that MRLs derived by EFSA in its assessment of 2021 are safe for consumers also in view of endocrine-disrupting properties, EFSA was requested to carry out a follow-up assessment taking into account the scientific criteria for identifying endocrine disruptors (ED). Based on the outcome of the assessment, the experts agreed that the reference values are also covering the concern related to the identified hazards indicative of endocrine disruption for thiophanate-methyl. No further considerations on the impact of the ED assessment on the current reference values were needed for carbendazim since the ED criteria are not met for this substance. Therefore, the risk assessment and the MRL recommendations derived in 2021 are confirmed., 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.)
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- 2024
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77. Modification of the existing maximum residue level for clopyralid in honey.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Mioč A, Nave S, Pedersen R, Reich H, Ruocco S, Scarlato AP, Szot M, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Corteva Agriscience International Sàrl submitted a request to the competent national authority in Finland to modify the existing maximum residue levels (MRLs) for the active substance clopyralid in honey. The data submitted in support of the request were found to be sufficient to derive MRL proposals for honey. Adequate analytical methods for enforcement are available to control the residues of clopyralid (including potential conjugates) in honey at the validated limit of quantification (LOQ) of 0.001 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of clopyralid residues in honey, resulting from the authorised use of clopyralid on oilseed rape notified in the present MRL assessment, is unlikely to present a risk to consumer health., 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.)
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- 2024
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78. Modification of the existing maximum residue levels for flonicamid in various crops.
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Bellisai G, Bernasconi G, Cabrera LC, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Mioč A, Nave S, Pedersen R, Reich H, Ruocco S, Scarlato AP, Szot M, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted two requests to the competent national authority in Finland and Belgium, respectively, to modify the existing maximum residue levels (MRLs) for the active substance flonicamid in potatoes and in various crops. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for potatoes, lettuces and salad plants, spinaches and similar leaves, beans (without pods), cardoons, celeries, Florence fennels and rhubarbs. Adequate analytical methods for enforcement are available to control the residues according to the residue definition as of the sum of flonicamid, TFNA and TFNG, expressed as flonicamid in the plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg for each compound. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the uses of flonicamid according to the reported agricultural practices is unlikely to present a risk to consumer health., 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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79. Modification of the temporary maximum residue levels for mepiquat in cultivated fungi and oyster mushrooms.
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Bellisai G, Bernasconi G, Cabrera LC, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Szot M, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Finland to modify the temporary maximum residue level (MRL) to a permanent MRL for the active substance mepiquat in cultivated fungi (with a specific MRL for oyster mushrooms). The data submitted in support of the request (monitoring data from food business operators) are not sufficient to derive permanent MRL proposals. The assessment of these data, complemented by an analysis of the most recent monitoring data available from EU monitoring programmes, supports the conclusion that the existing t -MRL for cultivated fungi is still sufficient to account for the residue uptake in cultivated mushrooms other than oyster mushrooms. It was also noted that lower t -MRLs could be derived based on the assessment of the most recent monitoring data. A risk management decision is still needed on whether to maintain the existing t -MRL value. Regarding oyster mushrooms, EFSA derived different options for risk managers to eventually update the values of the temporary MRLs based on the most recent monitoring data from food business operators. Adequate analytical methods for enforcement are available to control the residues of mepiquat (expressed as mepiquat chloride) in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the cross-contamination of untreated cultivated fungi (including oyster mushrooms) from cereal straw lawfully treated with mepiquat according to the current agricultural practices is unlikely to present a risk to consumer health., 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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80. Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for aluminium phosphide and magnesium phosphide.
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Bellisai G, Bernasconi G, Cabrera LC, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Szot M, Theobald A, Tiramani M, and Verani A
- Abstract
The applicant Detia Freyberg GmbH submitted to the competent national authority in Germany two requests to evaluate the confirmatory data that were identified for tree nuts, oilseeds, cereals and commodities of animal origin in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available and two requests in accordance with Article 6 of Regulation (EC) No 396/2005 to increase the existing MRL for the active substance aluminium phosphide in peanuts, barley, oat, rye, rice and wheat, roots of herbal infusions, cocoa beans and seed spices and for the active substance magnesium phosphide in oilseeds (except peanuts) and pistachios. The four applications were combined by EFSA under the current assessment. To address the data gaps, validation data for the method of analysis for enforcement of phosphide in high-oil content commodities and new residue trials were submitted. The data gaps on additional residue trials supporting authorisations on oilseeds and cereal grains, on clarifications regarding the discrepancies observed in the residue trial results for pistachios, and on data confirming the negligible occurrence of phosphane and its oxidation products in livestock products were considered addressed. The data gap on independent laboratory validation (ILV) and a confirmatory method for monitoring of phosphide in high-oil content commodities was considered not fully addressed. The information provided justified a lowering of the current tentative MRLs for the whole group of cereals (except rice and 'others'), an increase of the current tentative MRLs for pistachios, the whole group of oilseeds, rice and 'other' cereals, herbal infusions from roots, cocoa beans and seed spices, and a revision of the risk assessment performed for phosphane and its phosphide salts. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of AlP and Mg
3 P2 according to the reported agricultural practices is unlikely to present a risk to consumer health. Further risk management considerations are required., 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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81. Modification of the existing maximum residue level for mandipropamid in radish leaves.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Perez JM, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level (MRL) for the active substance mandipropamid in radish leaves (classified under the subgroup of kales), based on an intended indoor use on radishes. The residue data in radish leaves submitted in support of the request were found to be sufficient to derive an MRL proposal for this commodity. Adequate analytical methods for enforcement are available to control the residues of mandipropamid on the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that long-term intake of residues resulting from the use of mandipropamid according to the reported agricultural practice is unlikely to present a risk to consumer health. The reliable end points, appropriate for use in regulatory risk assessment are presented., 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2023
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82. Modification of the existing maximum residue levels for sulfoxaflor in various commodities.
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Bellisai G, Bernasconi G, Cabrera LC, Castellan I, Del Aguila M, Ferreira L, Giner Santonja G, Greco L, Jarrah S, Leuschner R, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Szot M, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request on behalf of Belgium (evaluating Member State, EMS) to modify the existing maximum residue levels (MRL) in okra/lady's fingers and various leaf vegetables, herbs and edible flowers. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under assessment. Adequate analytical methods for enforcement are available to control the residues of sulfoxaflor in plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of sulfoxaflor according to the reported agricultural practices is unlikely to present a risk to consumer health., 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2023
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83. Setting of an import tolerance for lambda-cyhalothrin in avocados.
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Bellisai G, Bernasconi G, Cabrera LC, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Szot M, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to set an import tolerance for the active substance lambda-cyhalothrin in avocados. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for avocados. Since the general data gap related to toxicity of degradation products formed under sterilisation conditions and identified in the framework of the MRL review has not yet been addressed, a risk management decision is required as to whether it is appropriate to take over the proposed MRLs in the MRL legislation. Adequate analytical methods for enforcement are available to control the residues of lambda-cyhalothrin in the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of lambda-cyhalothrin according to the reported agricultural practice is unlikely to present a risk to consumer health. However, the consumer exposure calculation shall be considered provisional, pending the toxicological assessment of the compounds formed under sterilisation conditions., 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2023
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84. Review of the existing maximum residue levels for zoxamide according to Article 12 of Regulation (EC) No 396/2005 and setting of an import tolerance for onions, garlic and shallots.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Perez JM, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Tiramani M, and Verani A
- 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 zoxamide. To assess the occurrence of zoxamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, the MRLs established by the Codex Alimentarius Commission and the European authorisations reported by Member States and the UK (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. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the Applicant Gowan Crop Protection Ltd, submitted a request to the competent national authority in Latvia to set an import tolerance for zoxamide in onions (extrapolated to garlic and shallots) based on the use authorised in USA. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under assessment. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of zoxamide according to the agricultural practices on onions, garlic and shallots is unlikely to present a risk to consumer health., 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2023
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85. Setting of an import tolerance for fenazaquin in hops.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Perez JM, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Gowan Crop Protection Limited submitted a request to the competent national authority in Greece to set an import tolerance for the active substance fenazaquin in hops imported from the United States of America. The data submitted in support of the request were found to be sufficient to derive an maximum residue limit (MRL) proposal for hops. An adequate analytical method for enforcement is available to control the residues of fenazaquin in the plant matrix under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues of fenazaquin and its toxicologically relevant plant metabolite TBPE resulting from the use of fenazaquin on imported hops from United States according to the reported agricultural practice is unlikely to present a risk to consumer health., 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2023
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86. Modification of the existing maximum residue levels and setting import tolerances for flupyradifurone and difluoroacetic acid (DFA) in various crops.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Perez JM, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer AG, Crop Science Division submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRL) and to set import tolerances for flupyradifurone and its metabolite difluoroacetic acid (DFA) in various plant commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for flupyradifurone and DFA in avocados, mangoes, papayas, asparagus, sesame seeds, sunflower seeds, sugar beet roots and chicory roots. Adequate analytical methods for enforcement are available to control the residues of flupyradifurone and DFA in plant matrices under consideration at the validated limits of quantification (LOQs) of 0.01 and 0.007 mg/kg, respectively. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of flupyradifurone and DFA residues resulting from the use of flupyradifurone according to the reported agricultural practices is unlikely to present a risk to consumer health., 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2023
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87. Targeted review of maximum residue levels (MRLs) for chlorfenapyr.
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Bellisai G, Bernasconi G, Binaglia M, Carrasco Cabrera L, Castellan I, Castoldi AF, Chiusolo A, Chukwubike K, Crivellente F, Del Aguila M, Ferreira L, Giner Santonja G, Greco L, Istace F, Jarrah S, Lanzoni A, Leuschner R, Mangas I, Martinez J, Miron I, Nave S, Panzarea M, Parra Morte JM, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Terron A, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non-approved active substance chlorfenapyr in view of the possible lowering of the MRL set for tea. This current EU MRL is based on an import tolerance established in 2007. EFSA reviewed the toxicological data assessed by other scientific bodies, proposing toxicological reference values to be used for an indicative risk assessment, noting that the values are affected by additional, non-standard uncertainties. According to the indicative chronic and acute dietary risk assessment the existing MRL for tea does not pose an unacceptable risk for consumers. Further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation., 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2023
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88. Targeted review of maximum residue levels (MRLs) for profenofos.
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Bellisai G, Bernasconi G, Binaglia M, Carrasco Cabrera L, Castellan I, Castoldi AF, Chiusolo A, Chukwubike K, Crivellente F, Del Aguila M, Ferreira L, Giner Santonja G, Greco L, Istace F, Jarrah S, Lanzoni A, Leuschner R, Mangas I, Martinez J, Miron I, Nave S, Panzarea M, Parra Morte JM, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Terron A, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non-approved active substance profenofos in view of the possible lowering of the MRL. EFSA investigated the origin of the current EU MRLs. Existing EU MRLs are based on Codex Maximum Residue Limits still in place or reflect temporary MRLs set from monitoring data. EFSA performed an indicative chronic and acute dietary risk assessment for the list of MRLs to allow risk managers to take the appropriate decisions. For some commodities, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation., 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2023
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- View/download PDF
89. Targeted review of maximum residue levels (MRLs) for diazinon.
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Bellisai G, Bernasconi G, Binaglia M, Carrasco Cabrera L, Castellan I, Castoldi AF, Chiusolo A, Chukwubike K, Crivellente F, Del Aguila M, Ferreira L, Giner Santonja G, Greco L, Istace F, Jarrah S, Lanzoni A, Leuschner R, Mangas I, Martinez J, Miron I, Nave S, Panzarea M, Parra Morte JM, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Terron A, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non-approved active substance diazinon in view of the possible lowering of the MRL. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex MRLs, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification. EFSA performed an indicative chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions. For some commodities, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation., 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2023
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90. Modification of the existing maximum residue level for propamocarb in honey.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Perez JM, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer AG Crop Science Division submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance propamocarb in honey. The data submitted in support of the request were found to be sufficient to derive MRL proposals for honey. Adequate analytical methods for enforcement are available to control the residues of propamocarb on the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of propamocarb according to the reported agricultural practice is unlikely to present a risk to consumer health., 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2023
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- View/download PDF
91. Evaluation of confirmatory data following the Article 12 MRL review for S-metolachlor.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Perez JM, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Tiramani M, and Verani A
- Abstract
The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for S-metolachlor in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new freezer storage stability study for S-metolachlor in commodities with high acid content was submitted. However, the data gap on storage stability was considered only partially addressed for strawberries because, in the absence of information on the storage time interval of the samples of the residue trials performed on strawberries, no conclusion on the validity of these trials could be drawn. The data gap on the lack of trials to support the good agricultural practice (GAP) on pineapples was not addressed. Consequently, the existing tentative MRLs for strawberries and pineapple cannot be confirmed and EFSA recommends lowering these MRLs to the enforcement limit of quantification (LOQ). Since a new lower LOQ for enforcement in high acid content commodities of 0.01 mg/kg has been validated, it is proposed to change the existing MRL value from 0.05* to 0.01* mg/kg for these two commodities., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2023
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92. Modification of the existing maximum residue levels for mefentrifluconazole in various commodities.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Perez JM, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro B.V. Arnhem (NL) Freienbach Branch submitted a request to the competent national authority in Austria to modify the existing maximum residue levels (MRLs) for the active substance mefentrifluconazole in various crops and swine liver and other swine products. The data submitted in support of the request were found to be sufficient to derive MRL proposals. Adequate analytical methods for enforcement are available to control the residues of mefentrifluconazole in the plant commodities under consideration and in animal matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg. New data relevant to the data gaps on storage stability and feeding studies of triazole derivative metabolites (TDMs), that were identified during the peer review of confirmatory data of the TDMs, were submitted in support of the present MRL application. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of mefentrifluconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. EFSA noted a narrow safety margin with regard to acute exposure to mefentrifluconazole residues from the intake of spinaches if residues occur at the level of the proposed MRL. EFSA also performed an indicative risk assessment for the TDMs based on uses of mefentrifluconazole only. The estimated exposure for TDMs did not exceed the toxicological reference values., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2023
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93. Modification of the existing maximum residue levels for pyrimethanil in table grapes, garlic and honey.
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Bellisai G, Bernasconi G, Cabrera LC, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Perez JM, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Ascenza Agro S.A. submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRL) for the active substance pyrimethanil in table grapes, garlic and honey. The data submitted in support of the request were found to be sufficient to derive MRL proposals for table grapes, garlic and honey. Adequate analytical methods for enforcement are available to control the residues of pyrimethanil in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the long-term intake of residues resulting from the use of pyrimethanil according to the reported agricultural practice is unlikely to present a risk to consumer health., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2023
- Full Text
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94. Modification of the existing maximum residue levels for metazachlor in leeks and honey.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Perez JM, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance metazachlor in leeks and honey. The data submitted in support of the request were found to be sufficient to derive MRL proposals. Adequate analytical methods for enforcement are available to control the residues of metazachlor metabolites 479 M04, 479 M08 and 479 M16 in plant matrices and honey at the validated limit of quantification (LOQ) of 0.01 and 0.02 mg/kg for each analyte. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of metazachlor according to the reported agricultural practice is unlikely to present a risk to consumer health., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2023
- Full Text
- View/download PDF
95. Modification of the existing maximum residue levels for difenoconazole in wheat and rye.
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Perez JM, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted an application to the competent national authority in Germany (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance difenoconazole in wheat and rye grain. The data submitted in support of the request were found sufficient to derive MRL proposals for wheat and rye grain. Adequate analytical methods for enforcement are available to control the residues of difenoconazole in plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. The submitted data indicate no need to modify the EU MRLs in animal commodities for the existing enforcement residue definition. EFSA concluded that the dietary exposure to difenoconazole residues from the intake of wheat and rye grain is low, noting that the impact of intended uses on the residues in animal commodities and the consumer exposure could not be properly addressed. Overall, the present risk assessment confirms a very narrow margin of safety for the overall chronic exposure and is considered provisional, pending the submission of confirmatory data on possible preferential metabolism/degradation of the four stereo isomers of difenoconazole in plants and animals and the impact of isomerisation on the toxicity of difenoconazole. The assessment is also affected by uncertainties related to the toxicological profile of animal metabolite CGA205375 and, additionally, it does not take into consideration triazole derivative metabolites (TDMs)., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2023
- Full Text
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96. Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole.
- Author
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Giner Santonja G, Greco L, Jarrah S, Leuschner R, Perez JM, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Tiramani M, and Verani A
- Abstract
The applicant Corteva Agrosciences submitted a request to the competent national authority in Slovenia to evaluate the confirmatory data that were identified for fenbuconazole in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the Article 12 confirmatory data gaps, new residue trials analysing triazole derivative metabolites (TDMs) were submitted on grapefruits, lemons, apples, pears, peaches, cherries and blueberries. Following the assessment of submitted data, EFSA concluded that Article 12 confirmatory data gaps are considered addressed for grapefruits, oranges, lemons, limes, pome fruits, peaches, cherries and blueberries. The calculated livestock dietary burdens indicated that for the individual TDMs, the trigger value of 0.004 mg/kg bw day is not exceed from the intake of apple pomace and citrus dried pulp. The new information provided required the assessment of consumer exposure to TDMs, which identified no consumer intake concerns for the crops under consideration. No data were submitted to address the Article 12 confirmatory data gaps for tree nuts, apricots, plums, table grapes, wine grapes, cranberries, bananas, sweet peppers/bell peppers, cucurbits with edible/inedible peel, peanuts/groundnuts, sunflower seeds and rapeseeds/canola seeds, barley, rye and wheat. For these commodities, the existing EU MRL could be lowered to the enforcement LOQ., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2023
- Full Text
- View/download PDF
97. Modification of the existing maximum residue level for azoxystrobin in hops.
- Author
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Perez JM, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance azoxystrobin in hops. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for hops. Adequate analytical methods for enforcement are available to control the residues of azoxystrobin on the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, noting that an acute risk assessment was not deemed necessary for azoxystrobin, EFSA concluded that the long-term intake of residues resulting from the use of azoxystrobin according to the reported agricultural practice is unlikely to present a risk to consumer health., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2023
- Full Text
- View/download PDF
98. Modification of the existing maximum residue levels or for flonicamid in kales, Chinese cabbages and kohlrabies.
- Author
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Giner Santonja G, Greco L, Jarrah S, Leuschner R, Perez JM, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant DLR-Rheinpfalz submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance flonicamid in Chinese cabbages, kales and kohlrabies. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the commodities under assessment. Adequate analytical methods for enforcement are available to control the residues of flonicamid, 4-trifluoromethylnicotinic acid (TFNA) and N -(4-trifluoromethylnicotinoyl) glycine (TFNG) (sum expressed as flonicamid) in the commodities under consideration at the validated combined limit of quantification (LOQ) of 0.03 mg/kg and the residues of flonicamid and TFNA-AM in animal matrices at the validated combined LOQ of 0.02 mg/kg. 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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2023
- Full Text
- View/download PDF
99. Modification of the existing maximum residue levels for prothioconazole in sugar beet and chicory roots.
- Author
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Bellisai G, Bernasconi G, Cabrera LC, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Perez JM, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Tiramani M, and Verani A
- Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience Deutschland GmbH submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance prothioconazole in sugar beet roots and chicory roots. The data submitted in support of the request were found to be sufficient to derive MRL proposals for sugar beet roots and chicory root. Adequate analytical methods for enforcement are available to control the residues of prothioconazole on the commodities under consideration at the validated limit of quantification (LOQ) of 0.02 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of prothioconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. An indicative exposure assessment to triazole derivative metabolites from the intended uses of prothioconazole did not indicate consumer intake concerns., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
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- 2023
- Full Text
- View/download PDF
100. Modification of the existing maximum residue levels for isofetamid in certain salad plants.
- Author
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Bellisai G, Bernasconi G, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Santonja GG, Greco L, Jarrah S, Leuschner R, Perez JM, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Tiramani M, and Verani A
- Abstract
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 Belgium to modify the existing maximum residue levels (MRLs) for the active substance isofetamid in certain salad plants. The data submitted in support of the request were found to be sufficient to derive MRL proposals for lamb's lettuces/corn salads, escaroles/broad leaved endives, cresses and other sprouts and shoots, land cresses, Roman rocket/rucola, red mustards, baby leaf crops (including brassica species) and other lettuces and salad plants. An adequate analytical method for enforcement is available to enforce the residues of isofetamid on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the uses of isofetamid according to the reported agricultural practices is unlikely to present a risk to consumer health., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2023
- Full Text
- View/download PDF
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