Anastassiadou Maria, Bernasconi Giovanni, 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, Theobald Anne, Vagenende Benedicte, Verani Alessia
EFSA J. 2020 Sep 28;18(9):e06239. doi: 10.2903/j.efsa.2020.6239. eCollection 2020 Sep.
The applicants Syngenta Crop Protection, UPL Europe Ltd. and Oxon Italia S.p.A. submitted requests to the competent national authority in the Netherlands to evaluate the confirmatory data for chlorothalonil that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available; in addition, Syngenta and UPL submitted requests for modifications of existing MRLs. Considering the recent decision on the non-approval of chlorothalonil, the requests for amending existing MRLs to reflect intended EU uses for chlorothalonil and confirmatory data for EU uses became obsolete. EFSA focused therefore its assessment on the import tolerances and on general information on the analytical method required to enforce legal limits for chlorothalonil and its metabolite SDS-3701 (R182281). Analytical methods for enforcement are available to control the residues of chlorothalonil and SDS-3701 in plant matrices at the validated LOQ of 0.01 mg/kg; data on the extraction efficiency for high oil content matrices as requested in the MRL review were not provided. This data gap is relevant for the import tolerance for peanuts. The data submitted in support of import tolerances were found to be sufficient to derive MRL proposals for chlorothalonil and SDS-3701 for bagged bananas, papayas and peanuts. Studies investigating the effect of high temperature processing on the magnitude of SDS-3701 in processed products are not available. Based on exposure calculations for chlorothalonil, EFSA concluded that the long-term intake of residues resulting from the use of chlorothalonil according to the reported agricultural practices is unlikely to present a risk to consumers. For papaya, an acute intake concern was noted for chlorothalonil, while for banana and peanuts, the expected short-term intake of chlorothalonil residues was below the toxicological reference value. For the metabolite SDS-3701, the toxicological profile is not fully elucidated, and therefore, toxicological reference values could not be derived. Hence, for this metabolite, the consumer risk assessment cannot be finalised.
申请人先正达作物保护公司、UPL欧洲有限公司和Oxon意大利股份公司向荷兰国家主管当局提交了申请，要求评估在《欧洲共同体理事会条例》（EC）No 396/2005第12条规定的最大残留限量审查框架内确定的百菌清的确认数据，这些数据被认定为不可用；此外，先正达和UPL提交了修改现有最大残留限量的申请。鉴于最近关于不批准百菌清的决定，修改现有最大残留限量以反映百菌清在欧盟预期用途及欧盟用途确认数据的申请已过时。因此，欧洲食品安全局将其评估重点放在进口容忍度以及执行百菌清及其代谢物SDS - 3701（R182281）法律限量所需分析方法的一般信息上。有用于执法的分析方法可控制植物基质中百菌清和SDS - 3701的残留量，验证限为0.01 mg/kg；但未提供最大残留限量审查中要求的高油含量基质提取效率的数据。这一数据缺口与花生的进口容忍度相关。支持进口容忍度提交的数据被认为足以得出袋装香蕉、木瓜和花生中百菌清及SDS - 3701的最大残留限量建议。目前尚无研究调查高温加工对加工产品中SDS - 3701含量的影响。基于对百菌清的暴露量计算，欧洲食品安全局得出结论，按照报告的农业实践使用百菌清产生的残留量长期摄入不太可能对消费者构成风险。对于木瓜，注意到百菌清存在急性摄入问题，而对于香蕉和花生，百菌清残留量的预期短期摄入量低于毒理学参考值。对于代谢物SDS - 3701，其毒理学特征尚未完全阐明，因此无法得出毒理学参考值。因此，对于该代谢物，无法完成消费者风险评估。
