EFSA J. 2022 Aug 26;20(8):e07133. doi: 10.2903/j.efsa.2022.7133. eCollection 2022 Aug.
In October 2021, the European Commission asked EFSA to provide scientific and technical assistance in accordance with Article 21(2) of Regulation (EC) No 1107/2009 and to deliver a statement on the information submitted by the applicant taking into consideration the assessment of the rapporteur Member State (RMS) in the context of the review of the approval of the active substance ipconazole. The current statement contains a summary of the main findings of the assessment of the risks posed to birds from use of ipconazole and whether the requirements regarding negligible exposure for humans (dietary and non-dietary exposure) set out in point 3.6.4 of Annex II to Regulation (EC) No 1107/2009 may be considered satisfied. The identified concerns are presented.
2021年10月,欧盟委员会要求欧洲食品安全局根据(EC)No 1107/2009号法规第21(2)条提供科学和技术援助,并就申请人提交的信息发表声明,同时考虑报告成员国(RMS)在活性物质抑霉唑批准审查背景下的评估。本声明总结了使用抑霉唑对鸟类造成风险评估的主要结果,以及是否可认为满足(EC)No 1107/2009号法规附件II第3.6.4点中关于人类可忽略暴露(膳食和非膳食暴露)的要求。文中列出了已确定的问题。