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 Mar 20;17(3):e05623. doi: 10.2903/j.efsa.2019.5623. eCollection 2019 Mar.
In accordance with Article 6 of Regulation (EC) No 396/2005, the FPS Health, Food chain safety and Environment of Belgium, submitted an application to modify the existing maximum residue level (MRL) for the active substance cyprodinil in Florence fennel to accommodate the intended use in the northern Europe. The submitted data were found sufficient to derive an MRL proposal of 4 mg/kg for cyprodinil in Florence fennel. Adequate analytical methods for enforcement are available to control the residues of cyprodinil in the plant matrix under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the long-term intake of residues resulting from the authorised uses of cyprodinil and the intended use on Florence fennel is unlikely to present a risk to consumer health. An indicative acute exposure assessment was performed, considering the acute reference dose (ARfD) proposed by the rapporteur Member State (RMS) in the framework of the currently ongoing renewal of the approval of cyprodinil; no acute health concerns were identified with regard to cyprodinil residues in Florence fennel. As the peer review on the renewal of the approval of cyprodinil in accordance with Regulation (EC) No 1107/2009 is currently ongoing, the conclusions reported in this reasoned opinion may need to be reconsidered in the light of the outcome of the peer review.
根据欧盟法规(EC)No 396/2005第6条,比利时联邦公共服务部健康、食品安全与环境司提交了一份申请,请求修改佛罗伦萨茴香中活性物质嘧菌环胺的现有最大残留限量(MRL),以适应其在北欧的预期用途。所提交的数据被认为足以得出佛罗伦萨茴香中嘧菌环胺的最大残留限量提案为4毫克/千克。有足够的执法分析方法来控制嘧菌环胺在相关植物基质中的残留,其验证定量限(LOQ)为0.01毫克/千克。基于风险评估结果,欧洲食品安全局得出结论,嘧菌环胺的授权使用以及在佛罗伦萨茴香上的预期用途所产生的残留物长期摄入不太可能对消费者健康构成风险。考虑到报告成员国(RMS)在当前嘧菌环胺批准续期框架内提议的急性参考剂量(ARfD),进行了指示性急性暴露评估;未发现佛罗伦萨茴香中嘧菌环胺残留存在急性健康问题。由于目前正在按照欧盟法规(EC)No 1107/2009对嘧菌环胺批准续期进行同行评审,本 reasoned opinion 中报告的结论可能需要根据同行评审结果重新考虑。