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. 2020 Dec 23;18(12):e06361. doi: 10.2903/j.efsa.2020.6361. eCollection 2020 Dec.
The applicant FMC Agricultural Solutions A/S submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified 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 storage stability study was submitted and information on an analytical method for determination of bifenthrin in eggs was made available. The data gaps were sufficiently addressed. The new information provided, did not require a revision of the existing MRLs. In addition, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant submitted a request to set import tolerances for bifenthrin in sweet corn and maize grain. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for maize grain only. For sweet corn, data gaps were identified which precluded the derivation of an MRL proposal. Adequate analytical methods for enforcement are available to control the residues of bifenthrin (sum of isomers) in plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg and in animal matrices. EFSA concluded that the short-term and long-term intake of residues resulting from the uses of bifenthrin according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment is affected by additional non-standard uncertainty related to the expiry of EU authorisation for a number of crops for which previously EU MRLs were established, and which are still included in the risk assessment.
申请人富美实农业解决方案公司向比利时国家主管当局提交了一项请求，要求评估在根据欧盟第396/2005号法规第12条进行的最大残留限量（MRL）审查框架内确定为不可用的确认数据。为填补数据空白，提交了一项新的储存稳定性研究，并提供了有关鸡蛋中联苯菊酯测定分析方法的信息。数据空白得到了充分解决。所提供的新信息不需要修订现有的最大残留限量。此外，根据欧盟第396/2005号法规第6条，申请人提交了一项请求，要求设定甜玉米和玉米粒中联苯菊酯的进口 tolerance。发现为支持该请求而提交的数据足以仅得出玉米粒的最大残留限量提案。对于甜玉米，发现存在数据空白，无法得出最大残留限量提案。有足够的执法分析方法来控制在所考虑的植物基质中以0.01 mg/kg的验证定量限（LOQ）和动物基质中联苯菊酯（异构体总和）的残留量。欧洲食品安全局得出结论，按照报告的农业实践使用联苯菊酯产生的残留量的短期和长期摄入不太可能对消费者健康构成风险。风险评估受到与欧盟对一些作物的授权到期相关的额外非标准不确定性的影响，这些作物以前已制定欧盟最大残留限量，并且仍包括在风险评估中。
