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对精喹禾灵、精喹禾灵-糠酯和丙炔喹禾灵进行第12条最大残留限量审查后的确认数据评估以及对精喹禾灵-糠酯现有最大残留限量的修订。

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.

作者信息

Bellisai Giulia, Bernasconi Giovanni, Carrasco Cabrera Luis, Castellan Irene, Del Aguila Monica, Ferreira Lucien, Santonja German Giner, Greco Luna, Jarrah Samira, Leuschner Renata, Mioč Andrea, Nave Stefanie, Pedersen Ragnor, Reich Hermine, Ruocco Silvia, Scarlato Alessia Pia, Szot Marta, Theobald Anne, Tiramani Manuela, Verani Alessia

出版信息

EFSA J. 2024 Feb 26;22(2):e8560. doi: 10.2903/j.efsa.2024.8560. eCollection 2024 Feb.

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.

摘要

申请人 Arysta Life Science Great Britain Limited 向克罗地亚国家主管当局提出请求,评估在《欧洲议会和理事会条例》(EC) No 396/2005 第 12 条规定的最大残留限量 (MRL) 审查框架下确定的精喹禾灵 -P- 丁酯的确认数据,因为这些数据不可用。由于在风险评估和监测方面,另外两种具有相同残留定义的精喹禾灵 -P 变体也存在第 12 条规定的数据缺口,欧洲食品安全局 (EFSA) 在本次评估中纳入了所有精喹禾灵 -P 变体:精喹禾灵 -P- 乙酯、精喹禾灵 -P- 丁酯和精吡氟禾草灵。此外,在提交给克罗地亚的申请中,申请人还根据《欧洲议会和理事会条例》(EC) No 396/2005 第 6 条,请求修改葡萄、向日葵籽和大豆中精喹禾灵 -P- 丁酯的现有最大残留限量。为解决数据缺口,根据指导文件 SANTE/2020/12830 Rev.1,提交了精喹禾灵 -P- 丁酯、精喹禾灵酸、精喹禾灵 - 戊酸和精喹禾灵 -P- 甘油酯在不同动物源基质中的水解效率的新数据,以及一种用于动物产品的经过验证的分析方法。欧洲食品安全局得出结论,家畜动物产品残留执法方法中包含的提取和水解效率验证的数据缺口仅在肌肉、禽肝和蛋方面得到了充分解决。对于植物产品,其余的数据缺口未得到解决。欧洲食品安全局还认为,在先前的最大残留限量申请中,已充分解决了香菜中精喹禾灵 -P- 乙酯的数据缺口。总体而言,提供的新信息需要修订几种植物和动物源产品的现有最大残留限量。还需要进一步的风险管理考虑。根据风险评估结果,欧洲食品安全局得出结论,按照报告的农业实践使用精喹禾灵 -P- 丁酯产生的残留物的短期和长期摄入量不太可能对消费者健康构成风险。

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