Hernandez Jerez Antonio, Adriaanse Paulien, Berny Philippe, Coja Tamara, Duquesne Sabine, Focks Andreas, Marinovich Marina, Millet Maurice, Pelkonen Olavi, Pieper Silvia, Tiktak Aaldrik, Topping Christopher, Widenfalk Anneli, Wilks Martin, Wolterink Gerrit, Rundlöf Maj, Ippolito Alessio, Linguadoca Alberto, Martino Laura, Panzarea Martina, Terron Andrea, Aldrich Annette
EFSA J. 2022 Jan 24;20(1):e07030. doi: 10.2903/j.efsa.2022.7030. eCollection 2022 Jan.
Flupyradifurone is a novel butenolide insecticide, first approved as an active substance for use in plant protection products by Commission Implementing Regulation (EU) 2015/2084. Following concerns that this substance may pose high risks to humans and the environment, the French authorities, in November 2020, asked the Commission to restrict its uses under Article 69 of Regulation (EC) No 1107/2009. To support this request, competent Authorities from France cited a series of literature papers investigating its hazards and/or exposure to humans and the environment. In addition, in June 2020, the Dutch Authorities notified the Commission, under Article 56 of Regulation (EC) No 1107/2009, of new information on flupyradifurone on the wild bee species . This notification is also referred to in the French notification on flupyradifurone. Consequently, the EFSA PPR Panel was mandated to quantify the likelihood of this body of evidence constituting proof of serious risks to humans or the environment. Therefore, the EFSA PPR Panel evaluated the likelihood of these studies indicating new or higher hazards and exposure to humans and the environment compared to previous EU assessments. A stepwise methodology was designed, including: (i) the initial screening; (ii) data extraction and critical appraisal based on the principles of OHAT/NTP; (iii) weight of evidence, including consideration of the previous EU assessments; (iv) uncertainty analysis, followed, whenever relevant, by an expert knowledge elicitation process. For the human health, only one study was considered relevant for the genotoxic potential of flupyradifurone . These data did not provide sufficient information to overrule the EU assessment, as studies already addressed the genotoxic potential of flupyradifurone. Environment: All available data investigated hazards in bee species. For honey bees, the likelihood of the new data indicating higher hazards than the previous EU assessment was considered low or moderate, with some uncertainties. However, among solitary bee species - which were not addressed in the previous EU assessment - there was evidence that may be disproportionately sensitive to flupyradifurone. This sensitivity, which may partially be explained by the low bodyweight of this species, was mechanistically linked to inadequate bodily metabolisation processes.
氟吡呋喃酮是一种新型丁烯内酯类杀虫剂，于2015年被欧盟委员会实施条例（EU）2015/2084首次批准作为活性物质用于植物保护产品。由于担心该物质可能对人类和环境构成高风险，法国当局于2020年11月要求欧盟委员会根据第（EC）1107/2009号条例第69条限制其使用。为支持这一请求，法国主管当局引用了一系列调查其对人类和环境危害及/或暴露情况的文献。此外，2020年6月，荷兰当局根据第（EC）1107/2009号条例第56条向欧盟委员会通报了有关氟吡呋喃酮对野生蜜蜂物种影响的新信息。法国关于氟吡呋喃酮的通报中也提及了这一通知。因此，欧洲食品安全局植物保护产品和残留物小组被要求量化这一系列证据构成对人类或环境严重风险证明的可能性。因此，欧洲食品安全局植物保护产品和残留物小组评估了这些研究表明与之前欧盟评估相比对人类和环境存在新的或更高危害及暴露情况的可能性。设计了一种逐步的方法，包括：（i）初步筛选；（ii）基于OHAT/NTP原则的数据提取和批判性评价；（iii）证据权重，包括考虑之前的欧盟评估；（iv）不确定性分析，必要时随后进行专家知识获取过程。对于人类健康，仅一项研究被认为与氟吡呋喃酮的遗传毒性潜力相关。这些数据没有提供足够信息推翻欧盟评估，因为已有研究探讨了氟吡呋喃酮的遗传毒性潜力。环境方面：所有现有数据均调查了蜜蜂物种中的危害。对于蜜蜂，新数据表明危害高于之前欧盟评估的可能性被认为较低或中等，存在一些不确定性。然而，在之前欧盟评估未涉及的独居蜜蜂物种中，有证据表明其可能对氟吡呋喃酮异常敏感。这种敏感性可能部分由该物种体重较低来解释，从机制上与身体代谢过程不足有关。
