Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Naegeli, Hanspeter; Bresson, Jean‐Louis; Dalmay, Tamás; Dewhurst, Ian Crawford; Epstein, Michelle M.; Firbank, Leslie George; Guerche, Philippe; Hejátko, Jan; Moreno, F. Javier; Mullins, Ewen; Nogué, Fabien; Rostoks, Nils; Serrano, Jose Juan Sánchez; Savoini, G.; Veromann, Eve; Veronesi, F.; Álvarez, Fernando; Ardizzone, Michele; Paraskevopoulos, K. M.

doi:10.2903/j.efsa.2018.5468

Cited by 3 publications

(2 citation statements)

References 7 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 1). EFSA has recently published a technical report on the safety assessment of genetically modified crops with Cry1Ac confirming previous EFSA opinions (EFSA et al, 2018b). No new information on allergenicity of the proteins newly expressed in this fourevent stack soybean that might change the previous conclusions of the GMO Panel has become available.…”

Section: Assessment Of Allergenicity Of Newly Expressed Proteinsmentioning

confidence: 58%

“…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 1). More recently, this aspect has been discussed in detail by EFSA (EFSA et al, 2018b;Parenti et al, 2019). 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: Assessment Of Allergenicity Of Newly Expressed Proteinsmentioning

confidence: 90%

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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: Assessment Of Allergenicity Of Newly Expressed Proteinsmentioning

confidence: 58%

Section: Assessment Of Allergenicity Of Newly Expressed Proteinsmentioning

confidence: 90%

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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Assessment of genetically modified soybean MON 87705 × MON 87708 × MON 89788, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐126)

Naegeli¹,

Bresson²,

Dalmay³

et al. 2020

EFS2

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Soybean MON 87705 9 MON 87708 9 MON 89788 (three-event stack soybean) was produced by conventional crossing to combine three single soybean events: MON 87705, MON 87708 and MON 89788. This combination is intended to alter the fatty acid profile in the seed (in particular increasing the levels of oleic acid) and tolerance to glyphosate-based and dicamba herbicides. The Genetically Modified Organisms Panel previously assessed the three single soybean events and did not identify safety concerns. No new data on the single soybean events, leading to modification of the original conclusions on their safety have been identified. 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 soybean events and of the newly expressed proteins in the three-event stack soybean does not give rise to food and feed safety and nutritional concerns. In the case of accidental release of viable three-event stack soybean seeds into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and the reporting intervals are in line with the intended uses of soybean MON 87705 9 MON 87708 9 MON 89788. Considering the altered fatty acid profile of the three-event stack soybean, a proposal for post-market monitoring needs to be provided by the applicant. The GMO Panel notes that in the context of this application EFSA-GMO-NL-2015-126 the applicant did not provide a 90-day study on MON 87705 soybean in line with the applicable legal requirements. Therefore, the GMO Panel is not in the position to finalise the risk assessment of soybean MON 87705 9 MON 87708 9 MON 89788 under the current regulatory frame.

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Scientific advice on the Testbiotech's requests for internal review of Commission Implementing Decisions (EU) No 2019/2083 and 2019/2084 on soybean MON 89788 and soybean A2704‐12 (applications EFSA‐GMO‐RX‐011 and EFSA‐GMO‐RX‐009)

2020

EFSA Supporting Publications

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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 Testbiotech against the Commission Implementing Decisions (EU) 2019/2083 and 2019/2084 renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified (GM) soybean MON 89788 (application EFSA‐GMO‐RX‐011) and soybean A2704‐12 (application EFSA‐GMO‐RX‐009). Testbiotech claims that EFSA should have requested from the applicants new field trials reflecting the different management practices and meteorological and agronomic conditions under which soybean A2704‐12 and soybean MON 89788 are expected to be grown, as well as new feeding studies with whole feed and food from these GM soybeans. EFSA analysed each of the scientific arguments put forward in the technical background of Testbiotech's complaint on soybean MON 89788 and soybean A2704‐12 and concludes that none reveals new information that would invalidate the previous risk assessment conclusions and risk management recommendations made by the EFSA scientific Panel on Genetically Modified organisms (GMO Panel). Therefore, EFSA considers that the previous GMO Panel risk assessment conclusions and risk management recommendations on soybean MON 89788 and soybean A2704‐12 remain valid and applicable.

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Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Cited by 3 publications

References 7 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 soybean MON 87705 × MON 87708 × MON 89788, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐126)

Scientific advice on the Testbiotech's requests for internal review of Commission Implementing Decisions (EU) No 2019/2083 and 2019/2084 on soybean MON 89788 and soybean A2704‐12 (applications EFSA‐GMO‐RX‐011 and EFSA‐GMO‐RX‐009)

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