**Background:** This document is a scientific opinion from the EFSA Panel on Genetically Modified Organisms (GMO Panel) regarding application EFSA‐GMO‐RX‐024 for the renewal of authorization of genetically modified herbicide-tolerant oilseed rape MS8, RF3, and MS8×RF3 (Unique Identifiers ACS‐BNØØ5‐8, ACS‐BNØØ3‐6, and ACS‐BNØØ5‐8×ACS‐BNØØ3‐6, respectively). The application was submitted by BASF Agricultural Solutions Seed US LLC under Regulation (EC) No 1829/2003. The scope excludes cultivation within the European Union. The original risk assessments were published by the EFSA GMO Panel in 2012 and 2017a, and the products were authorized by Commission Implementing Decision 2013/327/EU and (EU) 2019/1301.
**Methods:** The GMO Panel assessed data submitted in the renewal application, including: (1) 10 annual post-market environmental monitoring (PMEM) reports covering July 2011 to June 2021; (2) a scoping review of literature from June 2013 to November 2022, which identified 953 publications (after deduplication) and, after applying eligibility criteria, yielded 7 relevant publications for food and feed safety assessment; (3) updated bioinformatic analyses of insert and flanking sequences, potential allergenicity/toxicity of newly expressed proteins (Barnase, Barstar, PAT), possible horizontal gene transfer, and celiac disease-related epitopes; (4) additional studies performed by or on behalf of the applicant during the authorization period; and (5) a 90-day oral repeated dose toxicity study in rats with canola RF3 (study number M_584150‐01‐1), conducted in accordance with OECD TG 408 and GLP principles. The Panel evaluated these data for possible new hazards, modified exposure, or new scientific uncertainties not previously assessed.
**Key Results:** No adverse effects were reported in the general surveillance activities over the entire authorization period. The literature searches identified no publications raising safety concerns for human/animal health or the environment that would change original risk assessment conclusions on Barnase, Barstar, and PAT proteins. Updated bioinformatic analyses confirmed that the RF3 insert may have landed in the 3' UTR of a rotundifolia-like 21 gene, while no endogenous genes were interrupted by event MS8. The amino acid sequences of PAT, Barnase, and Barstar showed no significant similarities to toxins, allergens, or immunogenic gluten-related epitopes. Analyses of newly created ORFs within inserts and spanning junction sites also indicated no sequence similarities to toxins or allergens. Three elements of bacterial origin with sufficient length and sequence identity to facilitate homologous recombination with native bacterial genes were identified, but no pairs of sequences enabling transfer by double homologous recombination were found, and the recombinant DNA does not confer selective advantages to microorganisms. In the 90-day rat feeding study (Sprague Dawley Crl:CD(SD) rats, 16 per sex per group, 15% incorporation rate of oilseed rape meal), no treatment-related adverse effects were observed. A small number of statistically significant findings were noted (e.g., 33% reduction in body weight gain in males at weeks 7–8; 50% reduction in ambulatory counts at 51–60 min in both sexes combined; 150% increase in urobilinogen in females; 10% reduction in seminal vesicle/prostate weight; 10–20% reduction in thyroid/parathyroid weight in both sexes combined), but these were considered not adverse due to being within normal variation, of small magnitude, transient, or lacking consistent patterns with related parameters or histopathology findings.
**Clinical Implications:** This is a regulatory risk assessment for renewal of marketing authorization, not a clinical study. The GMO Panel concludes that, under the assumption that the DNA sequence of the events is identical to the originally assessed sequence, there is no evidence for new hazards, modified exposure, or scientific uncertainties that would change the original risk assessment conclusions. The PMEM plan (general surveillance of imported GM plant material coordinated by CropLife Europe) was deemed consistent with the application scope, though the Panel noted that monitoring is a risk management matter outside EFSA's mandate. The Panel also noted that the 15% incorporation rate of oilseed rape meal in the 90-day study was below the 25% upper limit proposed by EFSA (2014) and considered that further scientific investigations are required to confirm the applicability of the 25% limit.