Guidance for risk assessment of food and feed from genetically modified plants

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doi:10.2903/j.efsa.2011.2150

Cited by 356 publications

(291 citation statements)

References 14 publications

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“…The GMO Panel took into account Regulation (EU) No 503/2013 and the appropriate principles described in its guidelines for the risk assessment of GM plants and derived food and feed (EFSA GMO Panel, 2011a), the environmental risk assessment (ERA) of GM plants (EFSA GMO Panel, 2010a) and the post-market environmental monitoring (PMEM) of GM plants (EFSA GMO Panel, 2011b).…”

Section: Methodologiesmentioning

confidence: 99%

“…Therefore, animal studies on the food/ feed derived from soybean MON 87751 are not necessary (EFSA GMO Panel, 2011a). In accordance with Regulation (EU) No 503/2013 the applicant provided a 90-day oral repeated-dose toxicity study on whole food and feed from soybean MON 87751 in rats.…”

Section: Testing Of the Whole Genetically Modified Food And Feedmentioning

confidence: 99%

“…The statistical analysis of the agronomic, phenotypic and compositional data from the 2012 field trial study followed the recommendations of the GMO Panel (EFSA GMO Panel, 2010b, 2011a and complied with Regulation (EU) No 503/2013. This includes the application of a difference test (between the GM soybean and its conventional counterpart) and an equivalence test (between the GM soybean and the set of non-GM soybean reference varieties).…”

Section: Statistical Analysis Of Field Trial Data 18mentioning

confidence: 99%

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Assessment of genetically modified soybean MON 87751 for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐121)

Naegeli¹,

Birch²,

Casacuberta³

et al. 2018

EFS2

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Soybean MON 87751 was developed through Agrobacterium tumefaciens-mediated transformation to provide protection certain specific lepidopteran pests by the expression of the Cry1A.105 and Cry2Ab2 proteins derived from Bacillus thuringiensis. The molecular characterisation data and bioinformatic analyses did not identify issues requiring assessment for food and feed safety. None of the compositional, agronomic and phenotypic differences identified between soybean MON 87751 and the conventional counterpart required further assessment. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the Cry1A.105 and Cry2Ab2 proteins as expressed in soybean MON 87751, and found no evidence that the genetic modification might significantly change the overall allergenicity of soybean MON 87751. The nutritional impact of soybean MON 87751-derived food and feed is expected to be the same as those derived from the conventional counterpart and non-GM commercial reference varieties. The GMO Panel concludes that soybean MON 87751, as described in this application, is nutritionally equivalent to and as safe as the conventional counterpart and the non-GM soybean reference varieties tested, and no post-market monitoring of food and feed is considered necessary. In the case of accidental release of viable soybean MON 87751 seeds into the environment, soybean MON 87751 would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87751. In conclusion, soybean MON 87751, as described in this application, is as safe as its conventional counterpart and the tested non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment.

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Section: Methodologiesmentioning

confidence: 99%

Section: Testing Of the Whole Genetically Modified Food And Feedmentioning

confidence: 99%

Section: Statistical Analysis Of Field Trial Data 18mentioning

confidence: 99%

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Assessment of genetically modified soybean MON 87751 for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐121)

Naegeli¹,

Birch²,

Casacuberta³

et al. 2018

EFS2

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“…The applicant followed the relevant parts of the GMO Panel guideline for the risk assessment of GM plants (EFSA GMO Panel, 2011) The applicant had previously submitted information on the sequence of carnation FLO-40685-2, as part of notification C/NL/13/02 (EFSA GMO Panel, 2016). Carnation FLO-40685-2 contains inserts in four loci, as described below: À Locus 1: one copy of the T-DNA, containing the three expression cassettes and an incomplete copy of the T-DNA containing only the f3',5'h cassette with the right T-DNA border.…”

Section: Methodologiesmentioning

confidence: 99%

Risk assessment of new sequencing information on genetically modified carnation FLO‐40685‐2

Gennaro¹,

Olaru²,

Papadopoulou³

et al. 2018

EFS2

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The GMO Panel has previously assessed genetically modified (GM) carnation FLO-40685-2 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO-40685-2 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 7 November 2017, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for carnation FLO-40685-2 and to indicate whether the conclusions of the GMO Panel on the previously assessed GM carnation FLO-40685-2 remain valid. The new sequencing data indicated an additional three base pairs compared to the sequencing data originally provided: one base pair addition to the polyA tail of each of the two inserted flavonoid 3',5'-hydroxylase elements and one base pair addition to the sequence of one of the two D8 promoters in locus 1. These sequence differences are located outside the coding sequence for the newly expressed proteins and the base pairs described as differences in the new nucleic acid sequencing data for carnation FLO-40685-2 were reported to have been already present in the original plant material used for the risk assessment. Thus, with the exception of bioinformatics analyses, the studies performed for the risk assessment of GM carnation FLO-40685-2 remain valid. The new sequencing data and the bioinformatics analyses performed on the new sequence did not give rise to safety issues. Therefore, EFSA concludes that the original risk assessment of carnation FLO-40685-2 remains valid.

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“…The GMO Panel took into account the appropriate principles described in its guidelines for the risk assessment of GM plants and derived food and feed (EFSA, 2006a(EFSA, , 2007EFSA GMO Panel, 2011a), for the environmental risk assessment (ERA) of GM plants (EFSA GMO Panel, 2010b) and for the post-market environmental monitoring (PMEM) of GM plants (EFSA GMO Panel, 2011b).…”

Section: Methodologiesmentioning

confidence: 99%

Scientific Opinion on an application by Dow Agrosciences LLC (EFSA‐GMO‐NL‐2009‐68) for placing on the market of cotton 281‐24‐236 × 3006‐210‐23 × MON 88913 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Birch¹,

Casacuberta²,

Schrijver³

et al. 2016

EFS2

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The Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) previously assessed the three single events combined to produce a three-event stack cotton 281-24-236 9 3006-210-23 9 MON 88913 and did not identify safety concerns. In this opinion, the GMO Panel assesses only the three-event stack cotton. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. The combination of cotton events 281-24-236, 3006-210-23 and MON 88913 in the three-event stack cotton did not give rise to issues -based on the molecular, agronomic, phenotypic or compositional characteristics -regarding food and feed safety and nutrition. The combination of the newly expressed proteins in the threeevent stack cotton did not raise concerns for human and animal health. Considering the introduced traits and the outcome of the comparative analysis, the routes of exposure and limited exposure levels, the GMO Panel concludes that this three-event stack cotton would not raise safety concerns in case of accidental release of viable cottonseeds into the environment. The post-market environmental monitoring plans provided by the applicant are in line with the scope of the three-event stack cotton. No post-market monitoring of food/feed derived from the three-event stack cotton is considered necessary. The GMO Panel concludes that the three-event stack cotton is as safe and as nutritious as its conventional counterpart in the context of its scope.

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Guidance for risk assessment of food and feed from genetically modified plants

Cited by 356 publications

References 14 publications

Assessment of genetically modified soybean MON 87751 for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐121)

Assessment of genetically modified soybean MON 87751 for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐121)

Risk assessment of new sequencing information on genetically modified carnation FLO‐40685‐2

Scientific Opinion on an application by Dow Agrosciences LLC (EFSA‐GMO‐NL‐2009‐68) for placing on the market of cotton 281‐24‐236 × 3006‐210‐23 × MON 88913 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

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