Anastassiadou Maria, Brancato Alba, Brocca Daniela, Carrasco Cabrera Luis, Ferreira Lucien, Greco Luna, Jarrah Samira, Kazocina Aija, Leuschner Renata, Lostia Alfonso, Magrans Jose Oriol, Medina Paula, Miron Ileana, Pedersen Ragnor, Raczyk Marianna, Reich Hermine, Ruocco Silvia, Sacchi Angela, Santos Miguel, Stanek Alois, Tarazona Jose, Theobald Anne, Verani Alessia
EFSA J. 2019 May 22;17(5):e05704. doi: 10.2903/j.efsa.2019.5704. eCollection 2019 May.
The applicant BASF SE submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for bentazone in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new livestock feeding study and storage stability data for bentazone and 6-hydroxy bentazone in animal matrices were submitted. To address the data gap for potatoes, adjusted less critical good agricultural practices (GAPs) were reported and supporting residue data were provided. The data gap related to analytical methods in fat and herbal infusions were addressed in the framework of the peer review. The data gap for residue trials on leek has not been addressed. Further confirmation from the applicant/Member States are needed for the clarification of the GAP for herbal infusions. Based on the information submitted in support of the confirmatory data request, the existing EU MRLs for bentazone need to be modified for potato and leek, for swine fat and kidney and for bovine, equine, goat and sheep fat, liver and milk. The consumer risk assessment performed in the MRL review was updated, using new toxicological reference values derived by the peer review. No consumer intake concerns were identified.
申请人巴斯夫股份公司（BASF SE）向荷兰国家主管当局提出请求，评估在《欧洲共同体第396/2005号条例》第12条规定的最大残留限量（MRL）审查框架下，针对苯达松所确定的确认性数据，认为该数据不可用。为填补数据空白，提交了关于苯达松和6-羟基苯达松在动物基质中的新的家畜饲养研究和储存稳定性数据。为填补土豆的数据空白，报告了调整后的不太关键的良好农业规范（GAPs）并提供了支持性残留数据。在同行评审框架内解决了与脂肪和草药浸液分析方法相关的数据空白。韭菜残留试验的数据空白尚未得到解决。需要申请人/成员国进一步确认，以澄清草药浸液的GAP。根据为支持确认性数据请求而提交的信息，现有的欧盟苯达松最大残留限量需要针对土豆、韭菜、猪脂肪和肾脏以及牛、马、山羊和绵羊的脂肪、肝脏和牛奶进行修改。在最大残留限量审查中进行的消费者风险评估已更新，采用了同行评审得出的新毒理学参考值。未发现消费者摄入方面的问题。
