Brancato Alba, Brocca Daniela, Carrasco Cabrera Luis, De Lentdecker Chloe, Ferreira Lucien, Greco Luna, Jarrah Samira, Kardassi Dimitra, Leuschner Renata, Lythgo Christopher, Medina Paula, Miron Ileana, Molnar Tunde, Nougadere Alexandre, Pedersen Ragnor, Reich Hermine, Sacchi Angela, Santos Miguel, Stanek Alois, Sturma Juergen, Tarazona Jose, Theobald Anne, Vagenende Benedicte, Villamar-Bouza Laura
EFSA J. 2018 May 14;16(5):e05264. doi: 10.2903/j.efsa.2018.5264. eCollection 2018 May.
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in Belgium, to modify the existing maximum residue levels (MRL) for the active substance isofetamid in tomatoes, sweet peppers/bell peppers, aubergines/eggplants, okra/lady's fingers and the whole subgroup of cucurbits with edible peel. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the commodities under evaluation. Adequate analytical methods for enforcement are available to control the residues of isofetamid in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of isofetamid according to the reported agricultural practices is unlikely to present a risk to consumer health. The reliable end points appropriate for use in regulatory risk assessment are presented.
根据欧盟委员会第396/2005号法规第6条，申请人ISK Biosciences Europe N.V.向比利时国家主管当局提交了一项申请，请求修改番茄、甜椒、茄子、秋葵和带可食用果皮的整个葫芦科亚组中活性物质异菌脲的现有最大残留限量（MRL）。支持该申请提交的数据被认为足以得出所评估商品的MRL提案。有足够的执法分析方法来控制所考虑商品中异菌脲的残留，其验证定量限（LOQ）为0.01 mg/kg。基于风险评估结果，欧洲食品安全局得出结论，按照报告的农业实践使用异菌脲产生的残留短期和长期摄入不太可能对消费者健康构成风险。列出了适用于监管风险评估的可靠端点。
