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, Sacchi Angela, Santos Miguel, Stanek Alois, Theobald Anne, Vagenende Benedicte, Verani Alessia
EFSA J. 2019 Aug 2;17(8):e05798. doi: 10.2903/j.efsa.2019.5798. eCollection 2019 Aug.
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted an application to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for bentazone in soyabeans and poppy seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for both commodities. Adequate analytical methods for enforcement are available to control the residues of bentazone and its metabolites in plant matrices under consideration. The studies requested by EFSA in the framework of the peer review to address the toxicological properties of metabolite 6-hydroxy-bentazone were only partially provided. Instead of studies investigating the general toxicity of this metabolite, the applicant provided an argumentation to justify read-across from the available information on parent bentazone and 8-hydroxy-bentazone. EFSA did not agree with the provided reasoning for read-across. Therefore, the EMS asked EFSA to continue the assessment despite the data gap. EFSA performed an indicative short-term and long-term dietary risk assessment; the calculated dietary exposure was well below the toxicological reference values. The risk assessment however is affected by additional, non-standard uncertainties resulting from data gap related to the toxicological properties for 6-hydroxy-bentazone.
根据欧盟法规（EC）No 396/2005第6条，申请人巴斯夫股份公司向荷兰主管国家当局提交了一份申请，请求修改大豆和罂粟籽中嗪草酮的现有最大残留限量（MRLs）。提交的支持该请求的数据被认为足以得出这两种商品的MRL提案。有适用于执法的分析方法可用于控制所涉植物基质中嗪草酮及其代谢物的残留。欧洲食品安全局（EFSA）在同行评审框架内要求开展的有关代谢物6-羟基嗪草酮毒理学特性的研究仅部分提供。申请人未提供有关该代谢物一般毒性的研究，而是提供了一个论证，以证明可根据母体嗪草酮和8-羟基嗪草酮的现有信息进行类推。EFSA不同意所提供的类推理由。因此，评估小组要求EFSA尽管存在数据缺口仍继续进行评估。EFSA进行了指示性短期和长期膳食风险评估；计算得出的膳食暴露量远低于毒理学参考值。然而，风险评估受到与6-羟基嗪草酮毒理学特性相关的数据缺口所导致的额外非标准不确定性的影响。
