Assessment of genetically modified maize 4114 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐123)

GMO, maize (Zea mays), 4114, Cry1F, Cry34Ab1, Cry35Ab1, PAT, insect-resistant,herbicide tolerance, Regulation (EC) No 1829/2003
First published in the EFSA Journal
24 mai 2018
Adopted
19 avril 2018
Last Updated
5 juillet 2018. This version replaces the previous one/s.
Erratum/Corrigendum

A number of editorial corrections were made to the scientific output including removal of the reference to Devos et al. 2018. These do not materially affect the content or outcome of the output. The original version was removed from the EFSA Journal, but is available on request.

Type
Scientific Opinion

Abstract

Maize 4114 was developed through Agrobacterium tumefaciens‐mediated transformation to provide protection against certain lepidopteran and coleopteran pests by expression of the Cry1F, Cry34Ab1 and Cry35Ab1 proteins derived from Bacillus thuringiensis, and tolerance to the herbicidal active ingredient glufosinate‐ammonium by expression of the PAT protein derived from Streptomyces viridochromogenes. The molecular characterisation data did not identify issues requiring assessment for food/feed safety. None of the compositional, agronomic and phenotypic differences identified between maize 4114 and the non‐genetically modified (GM) comparator(s) required further assessment. There were no concerns regarding the potential toxicity and allergenicity of the newly expressed proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT, and no evidence that the genetic modification might significantly change the overall allergenicity of maize 4114. The nutritional value of food/feed derived from maize 4114 is not expected to differ from that derived from non‐GM maize varieties and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize 4114 grains into the environment, maize 4114 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize 4114. The genetically modified organism (GMO) Panel concludes that maize 4114 is as safe as the non‐GM comparator(s) and non‐GM reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.

Panel members at the time of adoption

Andrew Nicholas Birch, Josep Casacuberta, Adinda De Schrijver, Mikolaj AntoniGralak, Philippe Guerche, Huw Jones, Barbara Manachini, Antoine Messéan, Hanspeter Naegeli, ElsaEbbesen Nielsen, Fabien Nogué, Christophe Robaglia, Nils Rostoks, Jeremy Sweet, Christoph Tebbe,Francesco Visioli and Jean-Michel Wal
Panel on Genetically Modified Organisms
Contact
GMO [at] efsa.europa.eu
doi
10.2903/j.efsa.2018.5280
EFSA Journal 2018;16(5):5280
Question Number
On request from
Competent Authority of the Netherlands