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, Scarlato Alessia Pia, Theobald Anne, Vagenende Benedicte, Verani Alessia
EFSA J. 2021 Feb 26;19(2):e06430. doi: 10.2903/j.efsa.2021.6430. eCollection 2021 Feb.
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta France SAS submitted a request to the competent national authority in France to amend the residue definition for risk assessment and to modify the existing maximum residue levels (MRLs) for the active substance acibenzolar-S-methyl in beans (with pods) and peas (with pods). The toxicological data submitted in support of this MRL application were found to be sufficient to conclude that the plant metabolite 4-OH acibenzolar acid is not genotoxic in vitro, however lacking investigation of the general toxicity, a definitive conclusion cannot be derived whether 4-OH acibenzolar acid (free and conjugated) should be included or excluded from the residue definition for risk assessment for all commodities belonging to the groups of leafy crops and pulses/oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals on the basis of the current residue definition (sum of acibenzolar-S-methyl and acibenzolar acid (free and conjugated), expressed as acibenzolar-S-methyl) for the intended uses on lettuces and salad plants, beans (with pods) and peas (with pods). The available residue trials are sufficient to derive MRL proposals of 1 mg/kg for beans with pods and peas with pods. The submitted information did not provide evidence that the existing MRL has to be changed for the intended uses on lettuces and other salad plants. For herbs and edible flowers, data gaps were identified which precluded the derivation of MRL proposals. The consumer risk assessment for the current residue definition did not identify an unacceptable risk for consumers. The indicative exposure calculations performed for the metabolite 4-OH acibenzolar indicate that exposure to this metabolite is lower than the exposure to acibenzolar-S-methyl and acibenzolar acid (free and conjugated). However, considering the data gaps identified, a definitive conclusion cannot be derived by EFSA on the risk for consumers related to the intake of residues of 4-OH acibenzolar acid. The reliable end points appropriate for use in regulatory risk assessment are presented.
根据欧盟委员会第396/2005号法规第6条，申请人先正达法国公司向法国国家主管当局提交了一项请求，要求修订风险评估的残留定义，并修改豆类（带荚）和豌豆（带荚）中活性物质烯丙苯噻唑的现有最大残留限量（MRLs）。提交的支持该MRL申请的毒理学数据被认为足以得出结论，即植物代谢物4-羟基烯丙苯噻唑酸在体外无遗传毒性，然而，由于缺乏对一般毒性的研究，对于所有属于叶菜类作物和豆类/油籽类的商品，在风险评估的残留定义中是否应包括或排除4-羟基烯丙苯噻唑酸（游离和结合态），无法得出明确结论。支持该请求提交的数据被认为足以根据当前残留定义（烯丙苯噻唑和烯丙苯噻唑酸（游离和结合态）之和，以烯丙苯噻唑表示）得出生菜、沙拉植物、豆类（带荚）和豌豆（带荚）预期用途的MRL提案。现有的残留试验足以得出带荚豆类和带荚豌豆的MRL提案为1毫克/千克。提交的信息未提供证据表明生菜和其他沙拉植物的预期用途需要改变现有MRL。对于香草和食用花卉，发现了数据缺口，无法得出MRL提案。对当前残留定义的消费者风险评估未发现对消费者不可接受的风险。对代谢物4-羟基烯丙苯噻唑进行的指示性暴露计算表明，对该代谢物的暴露低于对烯丙苯噻唑和烯丙苯噻唑酸（游离和结合态）的暴露。然而，考虑到所发现的数据缺口，欧洲食品安全局无法就消费者摄入4-羟基烯丙苯噻唑酸残留的风险得出明确结论。列出了适用于监管风险评估的可靠终点。
