Guidance on the Post-Market Environmental Monitoring (PMEM) of genetically modified plants

Andersson, Hans; Arpaia, Salvatore; Bartsch, Detlef K.; Casacuberta, Josep; Davies, Howard V.; Jardin, Patrick du; Flachowsky, Gerhard; Herman, Lieve; Jones, Huw; Kärenlampi, Sirpa; Kiss, J.; Kleter, Gijs; Kuiper, H.A.; Messéan, Antoine; Nielsen, Kaare M.; Perry, J. N.; Pöting, Annette; Sweet, Jeremy; Tebbe, Christoph C.; Wal, Jean‐Michel

doi:10.2903/j.efsa.2011.2316

Cited by 130 publications

(67 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…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%

See 1 more Smart Citation

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

View full text Add to dashboard Cite

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.

show abstract

Section: Methodologiesmentioning

confidence: 99%

“…However, the GMO Panel gives its opinion on the scientific rationale of the PMEM plan provided by the applicant (EFSA GMO Panel, 2011b).…”

mentioning

confidence: 99%

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

View full text Add to dashboard Cite

show abstract

“…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%

“…However, the GMO Panel gives its opinion on the scientific content of the PMEM plan provided by the applicant (EFSA, 2006b;EFSA GMO Panel, 2011b). In addition, the GMO Panel acknowledges the approach proposed by the applicant to put in place appropriate management systems to restrict environmental exposure in the case of accidental release of viable GM cottonseeds.…”

Section: Post-market Environmental Monitoring 30mentioning

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

View full text Add to dashboard Cite

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.

show abstract

“…However, the EFSA GMO Panel gives its opinion on the scientific content of the PMEM plan provided by the notifier (EFSA GMO Panel, 2011). The potential exposure to the environment of carnation SHD-27531-4 would be mainly through (1) unintended release into the environment of GM carnations obtained by vegetative multiplication, (2) pollen dispersal from GM cut flowers to other carnations and wild relatives, (3) dispersal of seeds produced by GM cut flowers and possible progeny and (4) discarded GM carnation cut flowers resulting in possible exposure of environmental bacteria to recombinant DNA.…”

Section: Post-market Environmental Monitoring 12mentioning

confidence: 99%

Part C notification (reference C/NL/13/01) from Suntory Holdings Limited for the import, distribution and retailing of carnation SHD‐27531‐4 cut flowers with modified petal colour for ornamental use

Birch

Casacuberta²,

Schrijver³

et al. 2015

EFS2

View full text Add to dashboard Cite

The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) has evaluated the overall safety of genetically modified (GM) carnation SHD-27531-4 cut flowers to be imported into the European Union (EU) for ornamental use. The genetic modification results in the flowers having purple petals. The stability of the new colour trait was observed over multiple vegetative generations. The purple colour of the petals comes from the altered expression levels of anthocyanins, common pigments found in edible fruits and vegetables. Considering the intended use of the GM carnation and the possible routes of exposure, the EFSA GMO Panel did not find indications that the genetic modification will increase the risk of allergy among those coming into contact with carnations. Overall there are no reasons for safety concerns of carnation SHD-27351-4 for humans. The EFSA GMO Panel also considered whether viable seed or pollen from GM carnation cut flowers could be dispersed into the environment and whether GM carnation can be propagated by rooting. Owing to the limited environmental exposure and the biology of the plant, the EFSA GMO Panel did not identify any environmental safety concerns and agrees with the scope of the post-market environmental monitoring plan. The EFSA GMO Panel concludes that the import, distribution and retailing of the GM carnation will not cause adverse effects on human health or the environment. for humans. The EFSA GMO Panel also considered whether viable seed or pollen from GM carnation cut flowers could be dispersed into the environment and whether GM carnation can be propagated by rooting. Owing to the limited environmental exposure and the biology of the plant, the EFSA GMO Panel did not identify any environmental safety concerns and agrees with the scope of the postmarket environmental monitoring plan. The EFSA GMO Panel concludes that the import, distribution and retailing of the GM carnation will not cause adverse effects on human health or the environment.

show abstract

Guidance on the Post-Market Environmental Monitoring (PMEM) of genetically modified plants

Cited by 130 publications

References 28 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)

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

Part C notification (reference C/NL/13/01) from Suntory Holdings Limited for the import, distribution and retailing of carnation SHD‐27531‐4 cut flowers with modified petal colour for ornamental use

Contact Info

Product

Resources

About