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Following a request of the European Commission, the European Food Safety Authority (EFSA) reviewed the scientific arguments raised by the non‐governmental organisation Testbiotechrequestingthe review of Commission Implementing Decisions (EU) No 2021/66, 2021/61 and 2021/65, authorising the placing on the market of products containing, consisting of or produced from the four‐event stack soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 (application EFSA‐GMO‐NL‐2016‐128), the five‐event stack maize MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 and its subcombinations (application EFSA‐GMO‐NL‐2016‐134) and the four‐event stack maize MON 87427 × MON 89034 × MIR162 × MON 87411 and its subcombinations (application EFSA‐GMO‐NL‐2017‐144).In relation to the four‐event stack soybean and the five‐event stack maize, Testbiotech argued that the risk assessment performed by the EFSA Scientific Panel on Genetically Modified Organisms (EFSA GMO Panel) is insufficientas regards molecular characterisation, comparative analyses, toxicological and allergenicity assessment and environmental assessment. For the four‐event stack maize,Testbiotechclaims that the risk assessment performed by the EFSA GMO Panel is inadequateconsidering the general knowledge gaps in the assessment of RNAi‐based GM plants.EFSA's assessment focuses on scientific elements and does not cover legal aspects, as they are not in EFSA's remit and not in the frame of the mandate received from the EC. The assessment of the scientific arguments provided in the technical background of the three requests does not give enough justification to support the re‐examination of theEFSA GMO Panelrisk assessment conclusions and risk management recommendations. [ABSTRACT FROM AUTHOR]

The Risk "Assessment of genetically engineered organisms in the EU and Switzerland" (RAGES) project (2016‐2019) evaluated the risk assessment of genetically modified plants (GMPs) as performed by the European Food Safety Authority (EFSA) and its Swiss counterpart. RAGES claims shortcomings in several areas of the European risk assessment of GMPs, in particular: (1) the risk posed by herbicide tolerant GMPs on animal and human health; (2) the risk assessment approach of GMPs producing insecticidal proteins; (3) the risk assessment of nutritionally altered GMPs; (4) the assessment of GMPs combining different traits; (5) the environmental risk assessment of GMPs that can persist and spontaneously propagate in the environment; and (6) genetically modified organisms (GMOs) produced using new genetic engineering technologies. Following a request of the European Commission, EFSA reviewed the main scientific arguments raised by RAGES, and assessed whether thereports published by RAGES contain elements that could lead the GMO Panel to reconsider the outcome of its previous scientific opinions on GMPs. EFSA confirms that its risk assessment approach and data requirements are adequate and sufficient for the risk assessment of current GMPs, and that they are consistent with the applicable EU legislation and internationally agreed standards. Moreover, EFSAhas gained more than 20 years of experience in the risk assessment of GMPs, and conducts a continued scientific review of all relevant evidenceby following the scientific and technical developments in the GMO area.Overall, EFSA concludes that the final RAGES reports do not contain elements that would lead the GMO Panel to reconsider the outcome of its previous scientific opinions on GMPs. Therefore, EFSA considers that the previous GMO Panel risk assessment conclusions remain valid. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA assessed the scientific publication by Santos‐Vigil et al. (2018). The outstanding question was whether or not the new scientific information contains elements that could lead the EFSA GMO Panel to reconsider the outcome of its previous risk assessments on genetically modified crops expressing Cry1Ac protein. Santos‐Vigil et al. (2018) investigated the allergenic potential and immunological effects of the Cry1Ac protein and compared it with ovalbumin after intragastric administration to BALB/c mice, using a specific model of food‐allergy. Shortcomings in the study design and data interpretation limit the possibility to attribute findings to the intrinsic properties of the Cry1Ac protein. The publication by Santos‐Vigil et al. (2018) does not bring new elements that would lead the EFSA GMO Panel to reconsider the outcome of its previous scientific opinions on genetically modified crops with Cry1Ac. Therefore, EFSA considers that the previous risk assessment conclusions on GM crops with Cry1Ac remain valid and applicable. [ABSTRACT FROM AUTHOR]