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 9;19(2):e06407. doi: 10.2903/j.efsa.2021.6407. eCollection 2021 Feb.
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance difenoconazole in commodities belonging to the group of leafy brassica. The data submitted in support of the request were found to be sufficient to derive MRL proposals for leafy brassica. Adequate analytical methods for enforcement are available to control the residues of difenoconazole in plant matrices under consideration at the validated LOQ of 0.01 mg/kg and for difenoconazole and metabolite CGA205375 in animal matrices at the validated LOQ of 0.01 mg/kg for meat muscle, fat, liver, kidney and eggs and at the validated LOQ of 0.005 mg/kg for milk. Based on the risk assessment results, EFSA concluded that for the crops assessed in this application the short-term intake of residues resulting from the use of difenoconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. Long-term consumer intake concerns cannot be excluded for the intended and existing difenoconazole uses as they are affected by uncertainties associated with the toxicity of metabolite CGA205375 and the lack of information on all existing difenoconazole uses in the EU. Overall, this risk assessment is considered provisional, pending the submission of confirmatory data on possible preferential metabolism/degradation of the four stereo isomers of difenoconazole in plants and has to be re-considered when the missing data become available. Additionally, this assessment does not take into consideration triazole derivative metabolites (TDMs) which may be generated by several pesticides belonging to the group of triazole fungicides as this application was submitted before September 2019 which is the date of application of the new strategy endorsed by the risk managers for the assessment of TDMs.
根据欧盟委员会法规（EC）No 396/2005第6条，申请人先正达作物保护股份公司（Syngenta Crop Protection AG）向荷兰国家主管当局提交了一份申请，请求修改叶用芸苔属蔬菜中活性物质苯醚甲环唑的现有最大残留限量（MRLs）。所提交的支持该申请的数据被认为足以得出叶用芸苔属蔬菜的MRL提案。有足够的执法分析方法来控制植物基质中苯醚甲环唑的残留，其验证限为0.01 mg/kg；对于动物基质中的苯醚甲环唑及其代谢物CGA205375，肌肉、脂肪、肝脏、肾脏和鸡蛋的验证限为0.01 mg/kg，牛奶的验证限为0.005 mg/kg。基于风险评估结果，欧洲食品安全局（EFSA）得出结论，就本申请中评估的作物而言，按照报告的农业操作使用苯醚甲环唑所产生的残留短期摄入量不太可能对消费者健康构成风险。对于苯醚甲环唑的预期和现有用途，不能排除长期消费者摄入方面的担忧，因为这受到代谢物CGA205375毒性相关不确定性以及欧盟所有现有苯醚甲环唑用途信息缺乏的影响。总体而言，本次风险评估被视为临时评估，有待提交关于苯醚甲环唑四种立体异构体在植物中可能的优先代谢/降解的确认数据，并且当缺失数据可得时必须重新考虑。此外，本次评估未考虑三唑衍生物代谢物（TDMs），因为该申请是在2019年9月之前提交的，而2019年9月是风险管理者认可的TDMs评估新策略的应用日期，一些属于三唑类杀菌剂的农药可能会产生TDMs。
