Scientific Opinion on application (EFSA-GMO-CZ-2008-62) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and all sub-combinations of the individual events as present i

,

doi:10.2903/j.efsa.2010.1781

Cited by 10 publications

(13 citation statements)

References 25 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Similar conclusion was drawn for proteins Cry34Ab1, Cry35Ab1, Cry1F and PAT when assessing the two-event maize stack 1507 9 59122 (EFSA, 2009c). Furthermore, in the assessment of the four-event maize stack MON 89034 9 1507 9 MON 88017 9 59122, the GMO Panel concluded that the expression levels of proteins Cry1A.105, Cry2Ab2, Cry1F, PAT, Cry3Bb1, CP4 Table 8: Subcombinations of maize MON 89034 9 1507 9 MON 88017 9 59122 9 DAS-40278-9 not previously assessed and covered by the scope of application EFSA-GMO-NL-2013-113 EPSPS, Cry34Ab1 and Cry35Ab1 are comparable to those in the single events (EFSA GMO Panel, 2010c). This confirms that interactions affecting expression levels of the newly expressed proteins are not expected in the 14 maize subcombinations not previously assessed and included in the scope of application EFSA-GMO-NL-2013-113.…”

Section: Expression Of the Eventsmentioning

confidence: 99%

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐113)

Naegeli¹,

Bresson²,

Dalmay³

et al. 2019

EFS2

View full text Add to dashboard Cite

Maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 (five‐event stack maize) was produced by conventional crossing to combine five single events: MON 89034, 1507, MON 88017, 59122 and DAS‐40278‐9. The GMO Panel previously assessed the 5 single maize events and 11 of their subcombinations and did not identify safety concerns. No new data on the single maize events or their 11 subcombinations that could modify the original conclusions on their safety were identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicates 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 the five‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of the five‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the 14 maize subcombinations for which no experimental data were provided, and concludes that they are expected to be as safe as and nutritionally equivalent to 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 the five‐event stack maize. No post‐market monitoring of food/feed is 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 reference varieties with respect to potential effects on human and animal health and the environment.

show abstract

Section: Expression Of the Eventsmentioning

confidence: 99%

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐113)

Naegeli¹,

Bresson²,

Dalmay³

et al. 2019

EFS2

View full text Add to dashboard Cite

show abstract

“…The GMO Panel has previously assessed the two-event maize stacks 1507 9 59122 and MON 89034 9 MON 88017 and no safety concerns were identified (EFSA GMO Panel, 2009b, EFSA GMO Panel, 2010b. In addition, the GMO Panel has already assessed the four-event stack maize MON 89034 9 1507 9 MON 88017 9 59122 and all its subcombinations independently of their origin (see Table 2) and did not identify any safety concerns (EFSA GMO Panel, 2010c). Moreover, no scientific information relevant to the risk assessment of these maize stacks became available since the validation of application EFSA-GMO-BE-2013-118.…”

Section: Subcombinations Previously Assessedmentioning

confidence: 99%

Scientific Opinion on application EFSA‐GMO‐BE‐2013‐118 for authorisation of genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122 and subcombinations independently of their origin, for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto Company

Naegeli

Birch²,

Casacuberta³

et al. 2017

EFS2

View full text Add to dashboard Cite

In this opinion, the GMO Panel assessed the five‐event stack maize MON 87427 × MON 89034 ×1507 × MON 88017 × 59122 and its 25 subcombinations, independently of their origin. The GMO Panel has previously assessed the five single events combined to produce this five‐event stack maize and 11 subcombinations of these events and did not identify safety concerns. No new data on the single events or their previously assessed subcombinations, leading to modification of the original conclusions were identified. The combination of the single events and of the newly expressed proteins in the five‐event stack maize did not give rise to issues – based on the molecular, agronomic/phenotypic or compositional characteristics – regarding food and feed safety and nutrition. Considering the scope of this application, the known biological function of the newly expressed proteins and the data available for the five‐event stack maize and its previously assessed maize subcombinations, the GMO Panel considered that different combinations of the single events would not raise environmental concerns. The GMO Panel concludes that the five‐event stack maize is as safe and as nutritious as the non‐genetically modified (GM) comparator and the tested non‐GM reference varieties in the context of its scope. For the 14 maize subcombinations for which no experimental data were provided, the GMO Panel assessed the likelihood of interactions among the single events, and concluded that their combinations would not raise safety concerns. These maize subcombinations are therefore expected to be as safe as the single events, the previously assessed subcombinations and maize MON 87427 ×MON 89034 × 1507 × MON 88017 × 59122. Since the post‐market environmental monitoring plan for the five‐event stack maize does not include any provisions for the 14 maize subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly.

show abstract

“…Under the assumption that the DNA sequences of the events in maize MON 89034 × 1507 × MON 88017 × 59122 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF‐2022‐9170 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations (EFSA GMO Panel, 2010 , 2011 ).…”

Section: Discussionmentioning

confidence: 99%

“…Following the submission of application EFSA-GMO-CZ-2008-62 and the publication of the EFSA scientific opinion (EFSA GMO Panel, 2010Panel, , 2011, the placing on the market of maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations for (a) foods and food ingredients containing, consisting of, or produced from these GM maize lines, (b) feed containing, consisting of, or produced from these GM maize lines and (c) these GM maize lines in products containing them or consisting of them for any other use than (a) and (b), excluding cultivation in the EU, was authorised by Commission Implementing Decision 2013/650/EU. 4 A copy of this authorisation was provided by the applicant.…”

Section: Introductionmentioning

confidence: 99%

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2022‐9170)

Mullins,

Bresson,

Dalmay

et al. 2024

EFS2

View full text Add to dashboard Cite

Following the joint submission of dossier GMFF-2022-9170 under Regulation (EC) No 1829/2003 from Bayer Agriculture B.V. and Corteva Agriscience Belgium B.V., 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 herbicide tolerant and insect resistant genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. 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 sequences of the events in maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2022-9170 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations.

show abstract

Scientific Opinion on application (EFSA-GMO-CZ-2008-62) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and all sub-combinations of the individual events as present i

Cited by 10 publications

References 25 publications

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐113)

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐113)

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2022‐9170)

Contact Info

Product

Resources

About