Reasoned opinion on the import tolerance for glyphosate in genetically modified oilseed rape
In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the evaluating Member State (EMS), received an import tolerance application from the company DuPont de Nemours for the authorized use of glyphosate in Canada and United States on genetically modified oilseed rape containing the glyphosate N-acetyltransferase (gat) gene. The EMS assessed a new metabolism study and residue trials of glyphosate on oilseed rape containing the gat gene and concluded that there is no need to modify the existing residue definitions and MRLs for glyphosate. EFSA confirms the conclusions of the EMS that the metabolic pathway of glyphosate in genetically modified oilseed rape, maize and soybean containing the gat gene proceeds similarly and the current risk assessment residue definition is applicable. For enforcement, three options for residue definition as previously proposed by EFSA for glyphosate tolerant crops with gat gene are still valid. For the critical Canadian use, the existing EU MRL of 10 mg/kg in rape seed is found to be sufficient if the current enforcement residue definition “glyphosate” is maintained. For alternative enforcement residue definitions “sum of glyphosate and N-acetyl-glyphosate, expressed as glyphosate” and “N-acetyl-glyphosate, expressed as glyphosate”, a MRL proposal of 20 mg/kg is derived. Based on the risk assessment results, EFSA concludes that residues of glyphosate in genetically modified rape seed containing the gat gene will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern.