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, Santos Miguel, Scarlato Alessia Pia, Theobald Anne, Vagenende Benedicte, Verani Alessia
EFSA J. 2021 Feb 26;19(2):e06436. doi: 10.2903/j.efsa.2021.6436. eCollection 2021 Feb.
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Landwirtschaftliches Technologiezentrum Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance phenmedipham in strawberries. Noting that at least one additional trial is missing, an MRL of 0.7 mg/kg was derived for the intended NEU use of phenmedipham on strawberries. Adequate analytical methods for enforcement are available to control the residues of phenmedipham in strawberries at the validated limit of quantification (LOQ) of 0.01 mg/kg. Since the current MRL application was submitted before the finalisation of the EU pesticides peer review of the renewal of the approval of phenmedipham, the consumer exposure assessment was performed according to the conclusions on the toxicity of phenmedipham from the first approval under Directive 91/414/EEC. Accordingly, the long-term intake of residues of phenmedipham resulting from the existing and the intended uses is unlikely to present a risk to consumer health. EFSA notes that the present assessment does not take into account the data gaps identified in the context of the renewal of the approval of phenmedipham under Regulation (EC) No 1107/2009, which prevented experts to derive toxicological reference values (TRVs) for phenmedipham, to derive the risk assessment residue definition for fruit crops and to conclude on the toxicity of relevant metabolites.
根据欧盟委员会第396/2005号法规第6条,申请人奥古斯滕贝格农业技术中心向德国国家主管当局提交了一项申请,要求修改草莓中活性物质甜菜安的现有最大残留限量(MRL)。由于注意到至少缺少一项额外试验,因此得出甜菜安在草莓上预期新用途的最大残留限量为0.7毫克/千克。有足够的执法分析方法来控制草莓中甜菜安的残留量,其验证定量限(LOQ)为0.01毫克/千克。由于当前的最大残留限量申请是在欧盟农药同行评审对甜菜安再评审最终确定之前提交的,因此根据91/414/EEC指令首次批准时甜菜安的毒性结论进行了消费者暴露评估。因此,现有用途和预期用途产生的甜菜安残留的长期摄入量不太可能对消费者健康构成风险。欧洲食品安全局指出,本次评估未考虑在根据欧盟委员会第1107/2009号法规对甜菜安再评审过程中发现的数据缺口,这些缺口妨碍了专家得出甜菜安的毒理学参考值(TRV)、得出水果作物的风险评估残留定义以及对相关代谢物的毒性作出结论。