Setting of an import tolerance for glyphosate in soyabeans

Abstract

Abstract 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.

Keywords

• glyphosate
• genetically modified tolerant crop
• soyabeans
• pesticide
• MRL
• consumer risk assessment