Assessment of genetically modified maize MON 88017 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐014)

Abstract

Following the submission of application EFSA‐GMO‐RX‐014 under Regulation (EC) No 1829/2003 from Monsanto Company 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 insect‐resistant and herbicide‐tolerant genetically modified maize MON 88017, for food and feed uses, excluding cultivation within the EU. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. 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 88017 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐014 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 88017.

Assessment of genetically modified maize MON 88017 × MON 810 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐017)

“…The results of the updated bioinformatic analyses to assess the interruption of maize endogenous genes confirm previous results indicating the partial deletion of a putative maize purine permease 11 (MON 88017) (EFSA GMO Panel, 2020) and a putative maize E3 ubiquitin ligase (MON 810) (EFSA, 2009b). The analysis on gene interruption provided by the applicant using the MON 810 revealed that the sequences flanking the insert correspond to sequences that in the maize reference genome are located 12.5 million bases apart on chromosome 5.…”

“…Analyses of the amino acid sequence of the newly expressed Cry3Bb1, Cry1Ab and CP4 EPSPS proteins reveal no significant similarities to toxins, allergens or immunogenic gluten‐related epitopes. In addition, bioinformatic analyses of the newly created ORFs within the insert or spanning the junctions with genomic DNA confirm the previous conclusions indicating that the expression of ORFs showing significant similarities to toxins or allergens in maize MON 88017 × MON 810 is highly unlikely (EFSA, 2009b,c; EFSA GMO Panel, 2019, 2020).…”

“…The updated bioinformatic analysis for events MON 88017 and MON 810 did not reveal any DNA sequence that could provide sufficient length and identity which could facilitate horizontal gene transfer (HGT) by double homologous recombination, confirming previous conclusions (EFSA, 2009b;EFSA GMO Panel, 2017b, 2019, 2020. Given the results of this analysis and that the recombinant DNA in maize MON 88017 9 MON 810 does not confer selective advantages to microorganisms, the GMO Panel identified no safety concern linked to an unlikely but theoretically possible HGT.…”

Assessment of genetically modified maize DP202216 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2019‐159)

“…The PAT protein has been extensively characterised in previously authorised events assessed by the GMO Panel (e.g. EFSA GMO Panel, 2020 (AP142), 2018b (AP133), 2017b (AP92), and 2022 (AP161), 2023a (AP137), 2023b (AP140). Western blot analysis was employed to demonstrate the equivalence between PAT produced in maize DP202216 with plant‐derived proteins in previously assessed maize events 1507 and 59122 as well as its corresponding Escherichia coli ‐produced PAT protein.…”