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对咯菌腈进行第12条最大残留限量审查后的确认数据评估。

Evaluation of confirmatory data following the Article 12 MRL review for fludioxonil.

作者信息

Anastassiadou Maria, Brancato Alba, Carrasco Cabrera Luis, Ferreira Lucien, Greco Luna, Jarrah Samira, Kazocina Aija, Leuschner Renata, Magrans Jose Oriol, Miron Ileana, Nave Stefanie, Pedersen Ragnor, Reich Hermine, Rojas Alejandro, Sacchi Angela, Santos Miguel, Stanek Alois, Theobald Anne, Vagenende Benedicte, Verani Alessia

出版信息

EFSA J. 2019 Sep 17;17(9):e05812. doi: 10.2903/j.efsa.2019.5812. eCollection 2019 Sep.

Abstract

The applicant Syngenta submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The applicant provided residue trials on strawberries representative for an adjusted Good Agricultural Practice (GAP) and a new feeding study in ruminants. The data gaps identified in the MRL review were considered satisfactorily addressed, except for the southern adjusted GAP on strawberries. The new residue data confirm the existing tentative MRL for strawberries; EFSA proposed - based on the new feeding study in ruminants - amendments of the existing MRLs for certain animal products for further risk management consideration. EFSA updated the most recent consumer risk assessment for fludioxonil and concluded that the long-term dietary intake is unlikely to present a risk to consumer health.

摘要

申请人先正达向法国国家主管当局提交了一项请求,要求评估在根据欧盟第396/2005号法规第12条进行的最大残留限量(MRL)审查框架内确定为不可用的确认数据。申请人提供了适用于调整后的良好农业规范(GAP)的草莓残留试验以及一项新的反刍动物饲养研究。除了草莓的南方调整GAP外,MRL审查中确定的数据缺口被认为得到了令人满意的解决。新的残留数据证实了草莓现有的暂定MRL;欧洲食品安全局(EFSA)基于新的反刍动物饲养研究,提议对某些动物产品的现有MRL进行修订,以供进一步的风险管理考虑。EFSA更新了最新的咯菌腈消费者风险评估,并得出结论,长期膳食摄入不太可能对消费者健康构成风险。

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