EFSA J. 2021 Oct 28;19(10):e06880. doi: 10.2903/j.efsa.2021.6880. eCollection 2021 Oct.
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Corteva submitted a request to the competent national authority in Germany to set an import tolerance for the active substance glyphosate in genetically modified (GM) soyabeans imported from the USA. The genetic modification confers tolerance to the herbicide glyphosate. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for soyabeans. When the MRL is calculated according to the existing residue definition for enforcement in soyabeans (glyphosate only), there is no indication that the existing MRL of 20 mg/kg needs to be modified. However, an MRL of 50 mg/kg was also calculated in line with the residue definition for enforcement which has been proposed during the MRL review for glyphosate-tolerant (CP4-EPSPS) soybeans (sum of glyphosate, AMPA and N-acetyl-glyphosate, expressed as glyphosate). A risk management decision needs to be taken on the possible implementation of the residue definition for enforcement derived by the MRL review and therefore on the need to change the existing MRL for soyabeans. Adequate analytical methods for enforcement are available to control the residues of glyphosate, AMPA and N-acetyl-glyphosate in the commodity under consideration, at the validated limit of quantification (LOQ) of 0.05 mg/kg (for each compound). However, confirmatory methods for N-acetyl-glyphosate (in high water and high fat content matrices and dry commodities) and for AMPA (in all matrices) are still missing. EFSA concluded that the short-term and long-term intake of residues resulting from the existing uses of glyphosate and the import tolerance on soyabeans is unlikely to present a risk to consumer health. The chronic exposure calculation, however, is affected by uncertainties related to the data gaps identified during the MRL review and is based on the assumption that MRLs for the existing uses of glyphosate will be amended as recommended in the recent MRL review.
根据欧盟第396/2005号法规第6条，申请人科迪华向德国主管国家当局提交了一项申请，请求为从美国进口的转基因大豆中的活性物质草甘膦设定进口 tolerance。这种基因改造使大豆对除草剂草甘膦具有耐受性。提交的支持该申请的数据被认为足以得出大豆的最大残留限量（MRL）提案。当根据大豆现行执法残留定义（仅草甘膦）计算MRL时，没有迹象表明需要修改现行的20毫克/千克的MRL。然而，还根据草甘膦耐受（CP4 - EPSPS）大豆MRL审查期间提议的执法残留定义（草甘膦、氨甲基膦酸和N - 乙酰草甘膦之和，以草甘膦表示）计算出了50毫克/千克的MRL。需要就MRL审查得出的执法残留定义的可能实施情况做出风险管理决定，从而也就需要改变大豆现行MRL做出决定。有足够的执法分析方法来控制所审议商品中草甘膦、氨甲基膦酸和N - 乙酰草甘膦的残留，其验证定量限（LOQ）为0.05毫克/千克（每种化合物）。然而，仍然缺少针对N - 乙酰草甘膦（在高水分和高脂肪含量基质以及干燥商品中）和氨甲基膦酸（在所有基质中）的确证方法。欧洲食品安全局得出结论，草甘膦现有用途以及大豆进口 tolerance产生的残留的短期和长期摄入不太可能对消费者健康构成风险。然而，慢性暴露计算受到MRL审查期间确定的数据缺口相关不确定性的影响，并且基于草甘膦现有用途的MRL将按照最近MRL审查中的建议进行修订的假设。
