特丁拉西嗪第12条MRL审查后验证性数据的评价

IF 3.3 3区 农林科学 Q2 FOOD SCIENCE & TECHNOLOGY
European Food Safety Authority (EFSA), Giulia Bellisai, Giovanni Bernasconi, Luis Carrasco Cabrera, Irene Castellan, Monica del Aguila, Lucien Ferreira, Luna Greco, Samira Jarrah, Renata Leuschner, Andrea Mioč, Stefanie Nave, Hermine Reich, Silvia Ruocco, Alessia Pia Scarlato, Andrea Simonati, Marta Szot, Anne Theobald, Manuela Tiramani, Alessia Verani, Elena Zioga
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引用次数: 0

摘要

申请人先正达作物保护股份公司向西班牙国家主管部门提交了一份请求,要求根据法规(EC) No 396/2005第12条对活性物质terbuthylazine在最大残留水平(MRL)审查框架内确定的验证性数据进行评估,因为这些数据不可用。根据申请人提供的信息和西班牙的评估,欧洲食品安全局得出结论,在甜玉米和葵花籽中确认了暂定MRL,但在羽扇豆/羽扇豆和棉花籽中没有。关于牲畜代谢研究,EFSA承认提交了一项新的山羊代谢研究。然而,由于发现的缺点,反刍动物的新陈代谢不能完全描述。尽管存在这些缺陷,但可以得出的结论是,在计算的最大日粮负荷下,预计不会出现牛组织和牛奶中残留物的显著转移,因此可以确定暂定的最大残留限量。在MRL审查框架内进行的消费者风险评估使用修订3.1进行了更新。考虑到法规(EU) 2021/1795中实施的实际MRL值,并排除第12条确认数据不支持其用途的作物(棉花种子和羽绒豆/羽绒豆)。没有发现消费者摄入方面的问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Evaluation of confirmatory data following the Article 12 MRL review for terbuthylazine

Evaluation of confirmatory data following the Article 12 MRL review for terbuthylazine

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Spain to evaluate the confirmatory data that were identified for the active substance terbuthylazine in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. Based on the information provided by the applicant and assessed by Spain, EFSA concludes that the tentative MRL is confirmed in sweet corn and sunflower seeds, but not in lupins/lupini beans and cotton seeds. Regarding livestock metabolism study, EFSA acknowledges that a new goat metabolism study was submitted. However, due to the shortcomings identified, the metabolism in ruminants cannot be fully depicted. Despite these deficiencies, it can be concluded that at the calculated maximum dietary burdens significant transfer of residues in bovine tissues and milk is not expected and therefore the tentative MRLs can be confirmed. The consumer risk assessment performed in the framework of the MRL review was updated using revision 3.1. of the PRIMo, considering the actual MRL values implemented in Regulation (EU) 2021/1795 and excluding the crops on which the uses are not supported by Article 12 confirmatory data (cotton seed and lupins/lupini beans). No consumer intake concerns were identified.

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来源期刊
EFSA Journal
EFSA Journal Veterinary-Veterinary (miscellaneous)
CiteScore
5.20
自引率
21.20%
发文量
422
审稿时长
5 weeks
期刊介绍: The EFSA Journal covers methods of risk assessment, reports on data collected, and risk assessments in the individual areas of plant health, plant protection products and their residues, genetically modified organisms, additives and products or substances used in animal feed, animal health and welfare, biological hazards including BSE/TSE, contaminants in the food chain, food contact materials, enzymes, flavourings and processing aids, food additives and nutrient sources added to food, dietetic products, nutrition and allergies.
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