EFSA Panel on Genetically Modified Organisms (GMO), Josep Casacuberta, Francisco Barro, Albert Braeuning, Ruud de Maagd, Michelle M. Epstein, Thomas Frenzel, Jean-Luc Gallois, Frits Koning, Antoine Messéan, F. Javier Moreno, Fabien Nogué, Giovanni Savoini, Alan H. Schulman, Christoph Tebbe, Eve Veromann, Ana M. Camargo, Paolo Lenzi, Pietro Piffanelli, Tommaso Raffaello
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Camargo, Paolo Lenzi, Pietro Piffanelli, Tommaso Raffaello","doi":"10.2903/j.efsa.2025.9380","DOIUrl":null,"url":null,"abstract":"<p>Following the submission of dossier GMFF-2023-21254 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the of tissue-selective herbicide-tolerant genetically modified maize MON 87427, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. 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Under the assumption that the DNA sequence of the event in maize MON 87427 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2023-21254 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 87427.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3000,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9380","citationCount":"0","resultStr":"{\"title\":\"Assessment of genetically modified maize MON 87427 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21254)\",\"authors\":\"EFSA Panel on Genetically Modified Organisms (GMO), Josep Casacuberta, Francisco Barro, Albert Braeuning, Ruud de Maagd, Michelle M. 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引用次数: 0
摘要
继拜耳作物科学有限公司根据法规(EC) No 1829/2003提交GMFF-2023-21254档案后,欧洲食品安全局转基因生物小组被要求在更新组织选择性耐除草剂转基因玉米MON 87427的授权申请的背景下,对提交的数据进行科学风险评估,用于食品和饲料用途,不包括在欧盟境内种植。在续期申请中收到的数据包括上市后环境监测报告、通过范围审查检索到的文献评估、由申请人或代表申请人进行的其他研究的搜索以及更新的生物信息学分析。转基因生物小组对这些数据进行了评估,以确定在授权期间发现的可能的新危害、修改的暴露或新的科学不确定性,而这些在最初的申请背景下没有进行评估。在考虑更新的玉米MON 87427事件的DNA序列与最初评估的事件序列相同的假设下,转基因生物小组得出结论,更新档案GMFF-2023-21254中没有证据表明存在新的危害、修改暴露或科学不确定性,从而改变玉米MON 87427的原始风险评估结论。
Assessment of genetically modified maize MON 87427 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2023-21254)
Following the submission of dossier GMFF-2023-21254 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the of tissue-selective herbicide-tolerant genetically modified maize MON 87427, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in maize MON 87427 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2023-21254 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 87427.
期刊介绍:
The EFSA Journal covers methods of risk assessment, reports on data collected, and risk assessments in the individual areas of plant health, plant protection products and their residues, genetically modified organisms, additives and products or substances used in animal feed, animal health and welfare, biological hazards including BSE/TSE, contaminants in the food chain, food contact materials, enzymes, flavourings and processing aids, food additives and nutrient sources added to food, dietetic products, nutrition and allergies.