Relevance of new scientific information (Santos‐Vigil et al., 2018[Link]) in relation to the risk assessment of genetically modified crops with Cry1Ac

Dumont, Antonio Fernández; Lanzoni, Anna; Waigmann, Elisabeth; Paoletti, Claudia

doi:10.2903/sp.efsa.2019.en-1504

Cited by 10 publications

(7 citation statements)

References 31 publications

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“…For allergenicity, the GMO Panel has previously evaluated the safety of Cry1A.105, Cry2Ab2, Cry1Ac, DMO and CP4 EPSPS proteins individually, and no concerns on allergenicity were identified in the context of the applications assessed (Table ). EFSA has recently published a technical report on the safety assessment of genetically modified crops with Cry1Ac confirming previous EFSA opinions (EFSA et al., ). No new information on allergenicity of the proteins newly expressed in this four‐event stack soybean that might change the previous conclusions of the GMO Panel has become available.…”

Section: Assessmentsupporting

confidence: 66%

“…The Panel has previously evaluated the safety of Cry1A.105, Cry2Ab2 and Cry1Ac proteins, and no concerns on adjuvanticity were identified in the context of the applications assessed (see Table ). More recently, this aspect has been discussed in detail by EFSA (EFSA et al., ; Parenti et al., ). The levels of the individual Bt proteins in the four‐event stack soybean are comparable to those in the respective single soybean events (see Section 3.4.3).…”

Section: Assessmentmentioning

confidence: 99%

See 1 more Smart Citation

Assessment of genetically modified soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2016‐128)

Naegeli¹,

Bresson²,

Dalmay³

et al. 2019

EFS2

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Soybean MON 87751 9 MON 87701 9 MON 87708 9 MON 89788 (four-event stack soybean) was produced by conventional crossing to combine four single events: MON 87751, MON 87701, MON 87708 and MON 89788. The GMO Panel previously assessed the four single events and did not identify safety concerns. No new data on the single events have been identified that would lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological and allergenicity assessment indicate that the combination of the single soybean events and of the newly expressed proteins in the four-event stack soybean does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the four-event stack soybean, as described in this application, is as safe as and nutritionally equivalent to the non-GM comparator and the non-GM reference varieties tested. In the case of accidental release of viable seeds of the four-event stack soybean into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of the four-event stack soybean. Post-market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the four-event stack soybean is as safe as the non-GM comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.

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Section: Assessmentsupporting

confidence: 66%

Section: Assessmentmentioning

confidence: 99%

Assessment of genetically modified soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2016‐128)

Naegeli¹,

Bresson²,

Dalmay³

et al. 2019

EFS2

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“…The GMO Panel has previously evaluated the safety of the newly expressed proteins, and no evidence of adjuvanticity was identified in the context of the applications assessed (Table 2 ). This aspect has been discussed in detail by EFSA (EFSA, 2018 ; Parenti et al., 2019 ). To date, there is no evidence for adjuvanticity in the GMOs assessed by the Panel.…”

Section: Assessmentmentioning

confidence: 99%

Assessment of genetically modified maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9 for food and feed uses, under regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2018‐151)

Mullins¹,

Bresson²,

Dalmay³

et al. 2022

EFS2

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Genetically modified maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9 was developed by crossing to combine five single events: MON 89034, 1507, MIR162, NK603 and DAS‐40278‐9. The GMO Panel previously assessed the five single maize events and 16 of the subcombinations and did not identify safety concerns. No new data on the single maize events or the assessed subcombinations were identified that could lead to the modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the five‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that five‐event stack maize, as described in this application, is as safe as the non‐GM comparator and non‐GM maize varieties tested. In the case of accidental release of viable five‐event stack maize grains into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in nine of the maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the five‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the five‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM maize varieties with respect to potential effects on human and animal health and the environment.

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“…The GMO Panel and the scientific community at large acknowledge the difficulty in identifying adequate in vitro or in vivo methods for the assessment of the allergenic potential of proteins, in particular those investigating de novo sensitisation risk (FAO/WHO, ; EFSA GMO Panel, , ; Ladics et al., ; EFSA, Remington et al., ; Houben et al., ). The GMO Panel is aware of the fact that for allergenicity assessment in vitro cell‐based assays or in vivo tests on animal models have not yet been validated for regulatory purposes.…”

Section: Assessmentmentioning

confidence: 99%

“…Codex Alimentarius () establishes the principles for the allergenicity assessment highlighting that if additional in vitro and/or in vivo methods are necessary, they should be scientifically sound. In line with these considerations, the need to develop more robust approaches appropriately designed for risk assessment purposes when testing the allergenic potential of novel proteins and more broadly on their effects on the immune system has been highlighted (EFSA GMO Panel, , ; EFSA, ).…”

Section: Assessmentmentioning

confidence: 99%

Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐UK‐2006‐34) for authorisation of food and feed containing, consisting of and produced from genetically modified maize 3272

Naegeli¹,

Bresson²,

Dalmay³

et al. 2019

EFS2

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Following a request from the European Commission, the GMO Panel assessed additional information related to the application for authorisation of food and feed containing, consisting of and produced from genetically modified (GM) maize 3272 (EFSA- GMO-UK-2006-34). The applicant conducted new agronomic, phenotypic and compositional analysis studies on maize 3272 and assessed the allergenic potential of AMY797E protein, addressing elements that remained inconclusive from previous EFSA opinion issued in 2013. The GMO Panel is of the opinion that the agronomic and phenotypic characteristics as well as forage and grain composition of maize 3272 do not give rise to food and feed safety, and nutritional concerns when compared to non-GM maize. Considering the scope of this application and the characteristics of the trait introduced in this GM maize, the effect of processing and potential safety implications of specific food or feed products remain to be further investigated. Regarding the allergenic potential of AMY797E protein and considering all possible food and feed uses of maize 3272, the Panel concludes that the information provided does not fully address the concerns previously raised by the Panel in 2013. Owing to the nature and the knowledge available on this protein family, it is still unclear whether under specific circumstances the alpha-amylase AMY797E has the capacity to sensitise certain individuals and to cause adverse effects. To further support the safety of specific products of maize 3272, the applicant provided thorough information relevant for the allergenicity assessment of dried distiller grains with solubles (DDGS), which is the main product of interest for importation into the EU. Having considered the information provided on this product, the Panel is of the opinion that under the specific conditions of use described by the applicant, DDGS produced from maize 3272 does not raise concerns when compared to DDGS from non-GM maize.

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Relevance of new scientific information (Santos‐Vigil et al., 2018[Link]) in relation to the risk assessment of genetically modified crops with Cry1Ac

Cited by 10 publications

References 31 publications

Assessment of genetically modified soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2016‐128)

Assessment of genetically modified soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2016‐128)

Assessment of genetically modified maize MON 89034 × 1507 × MIR162 × NK603 × DAS‐40278‐9 for food and feed uses, under regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2018‐151)

Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐UK‐2006‐34) for authorisation of food and feed containing, consisting of and produced from genetically modified maize 3272

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