Dataset Information

Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for azoxystrobin.

ABSTRACT: The applicant Syngenta submitted a request to the competent national authority in the United Kingdom to evaluate the confirmatory data that were identified for azoxystrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available, and to consider new good agricultural practices (GAPs) for lettuces and other salad plants. To address the data gaps, new residue trials performed on open leaf varieties of lettuce supporting adjusted indoor, northern and southern GAPs, an assessment of the genotoxicity of the livestock metabolites L1, L4 and L9 and an assessment of the human dietary exposure to the livestock metabolites L1, L4 and L9 were submitted. The data gaps were considered partially addressed. The new information provided may require a revision (lowering) of the existing MRLs for lettuce and other salad plants and further risk management consideration for MRLs in animal commodities.

SUBMITTER: European Food Safety Authority (EFSA)

PROVIDER: S-EPMC7433686 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for azoxystrobin.

Anastassiadou Maria M Bernasconi Giovanni G Brancato Alba A Carrasco Cabrera Luis L Ferreira Lucien L Greco Luna L Jarrah Samira S Kazocina Aija A Leuschner Renata R Magrans Jose Oriol JO Miron Ileana I Nave Stefanie S Pedersen Ragnor R Reich Hermine H Rojas Alejandro A Sacchi Angela A Santos Miguel M Stanek Alois A Theobald Anne A Vagenende Benedicte B Verani Alessia A

EFSA journal. European Food Safety Authority 20200818 8

The applicant Syngenta submitted a request to the competent national authority in the United Kingdom to evaluate the confirmatory data that were identified for azoxystrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available, and to consider new good agricultural practices (GAPs) for lettuces and other salad plants. To address the data gaps, new residue trials performed on open leaf varieties of lettuce supporting adjusted indoor, northern and sout ...[more]

PMID: 32831949

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Project description:Applicability of the EFSA Scientific Committee revised draft Guidance on uncertainty in EFSA scientific assessment is tested in the context of an EFSA Reasoned Opinion on the modification of pesticide maximum residue levels (MRLs). EFSA purchased services for the preparation of a non-regulatory Evaluation Report with example non-standard uncertainties related to a fictitious application for the modification of MRLs. The Evaluation Report was assessed by EFSA in the format of a Reasoned Opinion and case-specific examples of non-standard uncertainty in the acute and chronic dietary risk assessments were analysed. Methods were selected from the general framework outlined in the Scientific Committee draft Guidance in order to apply a relatively simple strategy that could be considered for use in a regulatory context. The individual non-standard uncertainties were assessed by sensitivity analysis with iterative back-calculation of the parameter values that would lead to exceedance of the toxicological reference value (exceedance limit calculation), and quantified by subjective probability estimation. Non-standard uncertainties affecting the chronic risk assessment were quantified by subjective upper bound probability percentile estimation and the combined estimated non-standard uncertainty calculated by probability bounds analysis. Probability bounds analysis provides a relatively simple approach for calculating the probability related to a combination of uncertainties. The draft Guidance was found to provide a comprehensive range of methods for uncertainty analysis. However, process-specific guidelines and practical procedures may need to be developed in order to implement the uncertainty assessment framework in routine pesticide risk assessments. The uncertainty assessment is intended to provide additional information on how certain the conclusions of the risk assessment are and thereby support the risk-based decision-making process by enabling risk managers to take account of uncertainty. The outcome of the pilot study will inform the EFSA Scientific Committee Working Group on how to further tailor the draft Guidance on uncertainty for the needs of the EFSA panels and units.

Dataset Information

Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for azoxystrobin.

Publications

Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for azoxystrobin.

Similar Datasets

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