Brazil | BCH-RA-BR-113499 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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Risk Assessment generated by a regulatory process (RA)

last updated: 27 Dec 2017
General Information
Risk Assessment of NK603 x T25 maize tolerant to the herbicides glyphosate and glufosinate ammonium.
EN
05 Mar 2015
Risk assessment details
Methodology and points to consider
The CP4 EPSPS protein does not exhibit acute toxic effects in mammals. Results from acute oral toxicity studies in mice have demonstrated that the protein does not cause acute toxicity or adverse effects, even at high doses tested, much higher than those related to human exposure. The agronomic and phenotypic observations allowed to conclude that NK603 × T25 maize does not differ consistently from maize control. The data from the trials evaluated together show that NK603 × T25 maize does not impose a greater risk as a weed and does not result in a risk to the environment when compared to conventional maize.
EN
Even though it was concluded that there is no interaction between the CP4 EPSPS and PAT proteins, and these being not proteins with insecticidal activity against target pests, a survey of entomofauna was evaluated in the abundance of non-target organisms in field experiments conducted in Brazil harvest in five locations distributed in representative areas of maize crop in Brazil showed that there are no significant differences between genetically modified maize and conventional maize
EN
It can be concluded that NK603 × T25 maize is so safe, substantially equivalent and has no greater potential to become a weed or cause adverse effects to human and animal health or any adverse environmental impacts when compared to conventional maize or to events already assessed as safe
EN
Gene flow rate evaluation was performed at various distances from the genetically modified pollen source in all four directions. Due to the slope of the terrain and prevailing winds, the dispersion of the pollen produced by the hybrid AG 6016 (yellow seeds) was decreasing from the right side of the quadrant to the left side, counterclockwise. However, the results show that the pollen dispersal frequency in the four quadrants was drastically reduced, with fertilization values close to zero being recorded from the distance of 7.2 meters from the pollen source.
EN
the distance of 25-40 meters between the genetically modified organism and the conventional organism is sufficient to keep the threshold below the 0.9% allowed by the European Commission in the case of labeling. It is important to emphasize that in Brazil, this limit for labeling is 1%, according to Decree No. 4,680, dated 04/24/2003, which regulates the right to information, guaranteed by Law No. 8,078, of 09/11/1990.
EN
NK603 × T25 maize provides Brazilian farmers with the possibility of using two herbicides with different modes of action in weed control and as a weed resistance management tool
EN
As established in art. 1 of Law 11,460, of March 21, 2007, "are prohibited the research and the cultivation of genetically modified organisms in the indigenous lands and areas of conservation units".
EN
Molecular traditional methods
EN
Additional information
EN
Records referencing this document Show in search
Record type Field Record(s)
Country's Decision or any other Communication Risk assessment 1